{
"NDC": [
{
"NDCCode": "49281-790-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-790-20) / 10 mL in 1 VIAL, MULTI-DOSE (49281-790-38) ",
"NDC11Code": "49281-0790-20",
"ProductNDC": "49281-790",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Typhim Vi",
"NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19941128",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103936",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
"StrengthNumber": "25",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19941128",
"SamplePackage": "N",
"IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
"Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
},
{
"NDCCode": "49281-790-51",
"PackageDescription": "1 SYRINGE in 1 PACKAGE (49281-790-51) / .5 mL in 1 SYRINGE (49281-790-88) ",
"NDC11Code": "49281-0790-51",
"ProductNDC": "49281-790",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Typhim Vi",
"NonProprietaryName": "Salmonella Typhi Ty2 Vi Polysaccharide Antigen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19941128",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103936",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN",
"StrengthNumber": "25",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19941128",
"SamplePackage": "N",
"IndicationAndUsage": "Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.",
"Description": "Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex."
},
{
"NDCCode": "49281-190-20",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (49281-190-20) > 2 mL in 1 VIAL, SINGLE-DOSE (49281-190-58) ",
"NDC11Code": "49281-0190-20",
"ProductNDC": "49281-190",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Imogam Rabies-ht",
"NonProprietaryName": "Human Rabies Virus Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19840427",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103932",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "HUMAN RABIES VIRUS IMMUNE GLOBULIN",
"StrengthNumber": "150",
"StrengthUnit": "[iU]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19840427",
"SamplePackage": "N",
"IndicationAndUsage": "Rabies Immune Globulin (Human) Heat Treated, Imogam Rabies – HT, in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine. Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1). Inject Imogam Rabies – HT, as promptly as possible after exposure, along with the first dose of vaccine. If initiation of treatment is delayed for any reason, still administer Imogam Rabies – HT and the first dose of vaccine, regardless of the interval between exposure and treatment. If Rabies Immune Globulin (Human) was not administered when vaccination was begun (i.e., day 0), it can be administered up to and including day 7 of the post-exposure prophylaxis series. (1). In order to manage potential human exposures to rabies appropriately, the risk of infection must be accurately assessed. Rabies virus is usually transmitted by the bite of a rabid animal (dog, bat, etc.) but can occasionally penetrate abraded skin contaminated with the saliva of infected animals. Progress of the virus after exposure is believed to follow a neural pathway, and the time between exposure and clinical rabies is a function of the proximity of the bite (or abrasion) to the central nervous system and the dose of virus injected. The incubation is usually 2 to 6 weeks but can be longer. After severe bites about the face, neck, and arms, it may be as short as 10 days. After initiation of the vaccine series (human diploid cell origin), it takes approximately one week for development of immunity to rabies; therefore, the value of immediate passive immunization with rabies antibodies in the form of Rabies Immune Globulin (Human) cannot be overemphasized. Recommendations for passive and active immunization after exposure to an animal suspected of having rabies have been outlined by the WHO (3) and by the United States Public Health Service Advisory Committee on Immunization Practices (ACIP). (1). Centers for Disease Control (CDC) recommendations were derived from data on the safety and efficacy of active and passive rabies immunization from both uncontrolled human and animal studies.",
"Description": "Rabies Immune Globulin (Human) USP, Heat Treated, Imogam® Rabies – HT, is a sterile solution of antirabies immunoglobulin (10-16% protein) for wound infiltration and intramuscular administration. Rabies immune globulin (RIG) is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0.3 M glycine. The immune globulin solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. Imogam Rabies – HT is a clear or slightly opalescent, colorless or pale-yellow or light-brown liquid. During storage it may show formation of slight turbidity or a small amount of visible particulate matter. A heat-treatment process step (58° to 60°C, 10 hours) to inactivate viruses is used to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model laboratory strains of enveloped and non-enveloped viruses during the manufacturing and heat treatment processes for Imogam Rabies – HT have been validated by spiking experiments. Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were selected as relevant viruses for plasma derived products. Bovine viral diarrhea virus and Sindbis virus were chosen to model hepatitis C virus. Porcine pseudorabies virus was selected to model hepatitis B virus and herpes virus. Avian reovirus was used to model non-enveloped RNA viruses and for its relative resistance to inactivation by chemical and physical methods. Finally, porcine parvovirus was selected to model human parvovirus B19 and its notable resistance to inactivation by heat treatment. Removal and/or inactivation of the spiked model viruses was demonstrated at the precipitation III stage of manufacturing. In addition, inactivation was demonstrated to occur during the 10-hour (58° to 60°C) heat treatment process for the representative enveloped and non-enveloped viruses. The product is standardized against the United States (US) Standard Rabies Immune Globulin. The US unit of potency is equivalent to the International Unit (IU) for rabies antibody. The minimal potency is 150 IU/mL. The vial stopper is not made with natural rubber latex."
},
{
"NDCCode": "49281-400-20",
"PackageDescription": "5 SYRINGE in 1 PACKAGE (49281-400-20) / .5 mL in 1 SYRINGE (49281-400-89) ",
"NDC11Code": "49281-0400-20",
"ProductNDC": "49281-400",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Adacel",
"ProprietaryNameSuffix": "Tdap",
"NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20050610",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125111",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN",
"StrengthNumber": "5; 2; 2.5; 5; 3; 5",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050610",
"SamplePackage": "N",
"IndicationAndUsage": "Adacel® is a vaccine indicated for:. Active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in individuals 10 through 64 years of age. Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.",
"Description": "Adacel is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 5 Lf tetanus toxoid (T), 2 Lf diphtheria toxoid (d), and acellular pertussis antigens [2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL; however, Adacel is formulated with reduced quantities of diphtheria and detoxified PT. The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (2) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate. The tetanus toxin is produced from Clostridium tetani grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection. Adacel does not contain a preservative. In the guinea pig potency test, the tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of each of the FHA, PRN, and FIM acellular pertussis antigens is measured by an in vitro antigenicity enzyme-linked immunosorbent assay (ELISA). The potency of the PT acellular pertussis antigen is evaluated by the antibody response of immunized mice to detoxified PT as measured by ELISA. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate."
},
{
"NDCCode": "49281-618-20",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (49281-618-20) > 2.5 mL in 1 VIAL, MULTI-DOSE (49281-618-78) ",
"NDC11Code": "49281-0618-20",
"ProductNDC": "49281-618",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Antigen Component",
"NonProprietaryName": "Cov-2 Pres Dtm Antigen",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20201110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "COV-2 PRES DTM ANTIGEN",
"StrengthNumber": "50",
"StrengthUnit": "ug/2.5mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201110",
"SamplePackage": "N"
},
{
"NDCCode": "12634-790-57",
"PackageDescription": "20 TABLET in 1 BLISTER PACK (12634-790-57)",
"NDC11Code": "12634-0790-57",
"ProductNDC": "12634-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "12634-790-80",
"PackageDescription": "20 TABLET in 1 BOTTLE (12634-790-80)",
"NDC11Code": "12634-0790-80",
"ProductNDC": "12634-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "51079-790-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-790-20) > 1 TABLET in 1 BLISTER PACK (51079-790-01) ",
"NDC11Code": "51079-0790-20",
"ProductNDC": "51079-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19981023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074215",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19981023",
"SamplePackage": "N"
},
{
"NDCCode": "51523-790-25",
"PackageDescription": "1 CONTAINER in 1 CARTON (51523-790-25) > 20 g in 1 CONTAINER",
"NDC11Code": "51523-0790-25",
"ProductNDC": "51523-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Face It Aqua Uv Color Control",
"ProprietaryNameSuffix": "32800790",
"NonProprietaryName": "Octinoxate, Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THEFACESHOP CO., LTD.",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".2; .8; 2.3",
"StrengthUnit": "g/20g; g/20g; g/20g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71610-790-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (71610-790-20) ",
"NDC11Code": "71610-0790-20",
"ProductNDC": "71610-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075468",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240205",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders. Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS:Loss of Effect). Panic Disorder. Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ and Λ containing 1 mg or 2 mg of clonazepam respectively. Each tablet also contains lactose monohydrate, polyethylene 66 67 69 glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, with the following colourants: 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:."
},
{
"NDCCode": "49281-252-51",
"PackageDescription": "1 KIT in 1 PACKAGE (49281-252-51) * 1 mL in 1 VIAL, SINGLE-USE (49281-246-58) * 1 mL in 1 SYRINGE (49281-263-58) ",
"NDC11Code": "49281-0252-51",
"ProductNDC": "49281-252",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Imovax Rabies",
"NonProprietaryName": "Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water",
"DosageFormName": "KIT",
"StartMarketingDate": "20191025",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103931",
"LabelerName": "Sanofi Vaccines US Inc.",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "IMOVAX RABIES is a vaccine indicated for the prevention of rabies in all age groups. : 1 IMOVAX RABIES is approved for pre-exposure prophylaxis to prevent rabies., 2 IMOVAX RABIES is approved for post-exposure prophylaxis to prevent rabies.",
"Description": "IMOVAX RABIES (Rabies Vaccine) is a sterile, injectable suspension for intramuscular use. IMOVAX RABIES is supplied as a vial of lyophilized vaccine which must be reconstituted with the accompanying Sterile Water diluent. The vaccine is prepared from rabies vaccine virus strain PM-1503-3M. The vaccine virus is harvested from infected human diploid cells, MRC-5 cell line, concentrated by ultrafiltration and is inactivated by beta-propiolactone. One dose of reconstituted vaccine contains less than 100 mg human albumin, less than 150 mcg neomycin sulfate and 20 mcg of phenol red indicator. Beta-propiolactone, a residual component of the manufacturing process, is present in less than 50 parts per million. IMOVAX RABIES contains no preservative. The potency of one dose (1 mL) of IMOVAX RABIES is equal to or greater than 2.5 international units (IU) of rabies antigen. The vial stopper, the plunger rod and the tip cap of the syringe are not made with natural rubber latex."
},
{
"NDCCode": "49281-489-91",
"PackageDescription": "1 KIT in 1 PACKAGE (49281-489-91) * 5 mL in 1 VIAL, MULTI-DOSE (49281-488-78) * 6 mL in 1 VIAL (49281-466-91)",
"NDC11Code": "49281-0489-91",
"ProductNDC": "49281-489",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Menomune - A/c/y/w-135 Combined",
"NonProprietaryName": "Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen",
"DosageFormName": "KIT",
"StartMarketingDate": "19811123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103926",
"LabelerName": "Sanofi Pasteur Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-01-20"
},
{
"NDCCode": "49281-511-05",
"PackageDescription": "1 KIT in 1 PACKAGE (49281-511-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) ",
"NDC11Code": "49281-0511-05",
"ProductNDC": "49281-511",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Pentacel",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus And Haemophilus B Conjugate (tetanus Toxoid Conjugate) Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20080620",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125145",
"LabelerName": "Sanofi Vaccines US Inc.",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080620",
"SamplePackage": "N",
"IndicationAndUsage": "Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday).",
"Description": "Pentacel consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® component combined through reconstitution for intramuscular use. ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB component to form Pentacel. Pentacel is a uniform, cloudy, white to off-white (yellow tinge) suspension. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)] and 10 mcg PRP of H. influenzae type b covalently bound to 24 mcg of tetanus toxoid (PRP-T). Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 42.5 mg sucrose, 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (7) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (8) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (9) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype. PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (10) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The toxoid is filter sterilized prior to the conjugation process. The ActHIB component does not contain a preservative. Potency of the ActHIB component is specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate. The vial stoppers for the DTaP-IPV and ActHIB components of Pentacel are not made with natural rubber latex."
},
{
"NDCCode": "49281-562-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 PACKAGE (49281-562-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-562-58) ",
"NDC11Code": "49281-0562-10",
"ProductNDC": "49281-562",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Quadracel",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125525",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "20; 5; 3; 20; 5; 15; 40; 8; 32",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150324",
"SamplePackage": "N",
"IndicationAndUsage": "Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).",
"Description": "Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile suspension for intramuscular injection. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. Poliovirus Type 1, Type 2 and Type 3 are each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells, by the microcarrier method. (4) (5) The cells are grown in CMRL (Connaught Medical Research Laboratories) 1969 medium, supplemented with calf serum. For viral growth, the culture medium is replaced by Medium 199, without calf serum. After clarification and filtration, the viral suspensions are concentrated by ultrafiltration, and purified by liquid chromatography steps. The monovalent viral suspensions are inactivated with formaldehyde. Monovalent concentrates of each inactivated poliovirus are combined to produce a trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 ppm by calculation), <2 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 pg of neomycin and <4 pg polymyxin B sulfate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the inactivated poliovirus antigens is determined by measuring antibody-mediated neutralization of poliovirus in sera from immunized rats."
},
{
"NDCCode": "49281-564-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-564-58) ",
"NDC11Code": "49281-0564-10",
"ProductNDC": "49281-564",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Quadracel",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125525",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 5; 20; 20; 3; 5; 29; 7; 26",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150324",
"SamplePackage": "N",
"IndicationAndUsage": "Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).",
"Description": "Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype."
},
{
"NDCCode": "49281-564-15",
"PackageDescription": "10 SYRINGE in 1 PACKAGE (49281-564-15) / .5 mL in 1 SYRINGE (49281-564-88) ",
"NDC11Code": "49281-0564-15",
"ProductNDC": "49281-564",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Quadracel",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125525",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 5; 20; 20; 3; 5; 29; 7; 26",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
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"StartMarketingDatePackage": "20150324",
"SamplePackage": "N",
"IndicationAndUsage": "Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).",
"Description": "Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype."
},
{
"NDCCode": "49281-620-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-620-10) / .5 mL in 1 SYRINGE (49281-620-88) ",
"NDC11Code": "49281-0620-10",
"ProductNDC": "49281-620",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240304",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240304",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus contained in the vaccine. Flublok is approved for use in persons 18 years of age and older.",
"Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "49281-722-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-722-10) / .5 mL in 1 SYRINGE (49281-722-88) ",
"NDC11Code": "49281-0722-10",
"ProductNDC": "49281-722",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Quadrivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220701",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)].",
"Description": "Flublok Quadrivalent [Quadrivalent Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from four influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the four HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok Quadrivalent is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 180 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 4 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. A single 0.5 mL dose of Flublok Quadrivalent contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok Quadrivalent may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤19 mcg), baculovirus and cellular DNA (≤10 ng), and Triton X-100 (≤100 mcg). Flublok Quadrivalent contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "49281-723-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-723-10) / .5 mL in 1 SYRINGE (49281-723-88) ",
"NDC11Code": "49281-0723-10",
"ProductNDC": "49281-723",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Quadrivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20230630",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230630",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)].",
"Description": "Flublok Quadrivalent [Quadrivalent Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from four influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the four HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok Quadrivalent is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 180 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 4 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. A single 0.5 mL dose of Flublok Quadrivalent contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok Quadrivalent may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤19 mcg), baculovirus and cellular DNA (≤10 ng), and Triton X-100 (≤100 mcg). Flublok Quadrivalent contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "49281-724-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-724-10) / .5 mL in 1 SYRINGE (49281-724-88) ",
"NDC11Code": "49281-0724-10",
"ProductNDC": "49281-724",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/massachusetts/18/2022 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240701",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/MASSACHUSETTS/18/2022 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240701",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.",
"Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2024-2025 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Massachusetts/18/2022 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "49281-725-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-725-10) / .5 mL in 1 SYRINGE (49281-725-88) ",
"NDC11Code": "49281-0725-10",
"ProductNDC": "49281-725",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/district Of Columbia/27/2023 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250701",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/DISTRICT OF COLUMBIA/27/2023 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250701",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.",
"Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2025-2026 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/District of Columbia/27/2023 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "49281-726-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-726-10) / .5 mL in 1 SYRINGE (49281-726-88) ",
"NDC11Code": "49281-0726-10",
"ProductNDC": "49281-726",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260702",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260702",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.",
"Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
},
{
"NDCCode": "50090-7544-0",
"PackageDescription": "1 KIT in 1 KIT (50090-7544-0) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) ",
"NDC11Code": "50090-7544-00",
"ProductNDC": "50090-7544",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Pentacel",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus And Haemophilus B Conjugate (tetanus Toxoid Conjugate) Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20080620",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125145",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080620",
"SamplePackage": "N",
"IndicationAndUsage": "Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday).",
"Description": "Pentacel consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® component combined through reconstitution for intramuscular injection. ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB component to form Pentacel. Pentacel is a uniform, cloudy, white to off-white (yellow tinge) suspension. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)] and 10 mcg PRP of H. influenzae type b covalently bound to 24 mcg of tetanus toxoid (PRP-T). Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 42.5 mg sucrose, 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (7) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (8) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (9) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The potency of inactivated poliovirus antigens is determined by measuring antibody-mediated neutralization of poliovirus in sera from immunized rats. PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (10) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The toxoid is filter sterilized prior to the conjugation process. The ActHIB component does not contain a preservative. Potency of the ActHIB component is specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate. The vial stoppers for the DTaP-IPV and ActHIB components of Pentacel are not made with natural rubber latex."
},
{
"NDCCode": "0409-7811-37",
"PackageDescription": "20 POUCH in 1 CASE (0409-7811-37) / 4 BAG in 1 POUCH (0409-7811-32) / 100 mL in 1 BAG (0409-7811-11) ",
"NDC11Code": "00409-7811-37",
"ProductNDC": "0409-7811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050907",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018890",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20050919",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Anaerobic Infections. Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. Metronidazole is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. Intra-abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus). Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. Skin and Skin Structure Infections caused by Bacteroides species including B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species. Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species. Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species. Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. Endocarditis caused by Bacteroides species including the B. fragilis group. Prophylaxis. The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION). To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole Injection, USP is a sterile, nonpyrogenic, isotonic, buffered parenteral dosage form of metronidazole in water for injection. Each 100 mL contains metronidazole 500 mg (5 mg/mL) and sodium chloride 790 mg in water for injection; with dibasic sodium phosphate (anhydrous) 48 mg and citric acid (anhydrous) 23 mg added as buffers. The osmolarity of this solution is 314 mOsmol/liter (calc.). Each 100 mL contains 14 mEq sodium, pH 5.8 (4.5 ― 7.0). Metronidazole is classified as a synthetic antibacterial and antiprotozoal agent and is administered by the intravenous route. Metronidazole, USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C6H9N3O3), a crystalline powder sparingly soluble in water. It has the following structural formula. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "10967-790-27",
"PackageDescription": "76 g in 1 BOTTLE, WITH APPLICATOR (10967-790-27) ",
"NDC11Code": "10967-0790-27",
"ProductNDC": "10967-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mitchum Ultimate- 72 Hour Protection - Wild Energy Solid - Apdeo",
"NonProprietaryName": "Antiperspirant And Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Revlon Consumer Products Corp.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "20.2",
"StrengthUnit": "g/76g",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underam wetness."
},
{
"NDCCode": "11712-790-01",
"PackageDescription": "25 kg in 1 DRUM (11712-790-01)",
"NDC11Code": "11712-0790-01",
"ProductNDC": "11712-790",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pentamidine Isethionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19860723",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DELMAR CHEMICALS INC",
"SubstanceName": "PENTAMIDINE ISETHIONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2017-12-20",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "24208-790-62",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-790-62) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0790-62",
"ProductNDC": "24208-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Gramicidin",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Gramicidin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064047",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN",
"StrengthNumber": "1.75; 10000; .025",
"StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2024-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960131",
"SamplePackage": "N",
"IndicationAndUsage": "Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.",
"Description": "Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: Actives:neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg; Inactives:sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0). Preservative:thimerosal 0.001%. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiaeWaksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are. Polymyxin B Sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of Bacillus polymyxa(Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:. Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevisDubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:."
},
{
"NDCCode": "36800-790-10",
"PackageDescription": "1 BOTTLE in 1 BOX (36800-790-10) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "36800-0790-10",
"ProductNDC": "36800-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TOP CARE (Topco Associates LLC)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "36800-790-40",
"PackageDescription": "400 TABLET in 1 BOTTLE (36800-790-40) ",
"NDC11Code": "36800-0790-40",
"ProductNDC": "36800-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TOP CARE (Topco Associates LLC)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "42291-790-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42291-790-30) ",
"NDC11Code": "42291-0790-30",
"ProductNDC": "42291-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204415",
"LabelerName": "AvKARE",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171220",
"SamplePackage": "N",
"Description": "Telmisartan is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc. Telmisartan tablets, USP are hygroscopic and require protection from moisture."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49281-790-20</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-790-20) / 10 mL in 1 VIAL, MULTI-DOSE (49281-790-38) </PackageDescription>
<NDC11Code>49281-0790-20</NDC11Code>
<ProductNDC>49281-790</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Typhim Vi</ProprietaryName>
<NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19941128</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103936</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
<Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-790-51</NDCCode>
<PackageDescription>1 SYRINGE in 1 PACKAGE (49281-790-51) / .5 mL in 1 SYRINGE (49281-790-88) </PackageDescription>
<NDC11Code>49281-0790-51</NDC11Code>
<ProductNDC>49281-790</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Typhim Vi</ProprietaryName>
<NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19941128</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103936</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>19941128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi. Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14). Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14). Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14). An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section. Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.</IndicationAndUsage>
<Description>Typhim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Winthrop Industrie , for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. The organism is grown in a semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper and the plunger stopper of the syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-190-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (49281-190-20) > 2 mL in 1 VIAL, SINGLE-DOSE (49281-190-58) </PackageDescription>
<NDC11Code>49281-0190-20</NDC11Code>
<ProductNDC>49281-190</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Imogam Rabies-ht</ProprietaryName>
<NonProprietaryName>Human Rabies Virus Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19840427</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103932</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>HUMAN RABIES VIRUS IMMUNE GLOBULIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rabies Immune Globulin (Human) Heat Treated, Imogam Rabies – HT, in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine. Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1). Inject Imogam Rabies – HT, as promptly as possible after exposure, along with the first dose of vaccine. If initiation of treatment is delayed for any reason, still administer Imogam Rabies – HT and the first dose of vaccine, regardless of the interval between exposure and treatment. If Rabies Immune Globulin (Human) was not administered when vaccination was begun (i.e., day 0), it can be administered up to and including day 7 of the post-exposure prophylaxis series. (1). In order to manage potential human exposures to rabies appropriately, the risk of infection must be accurately assessed. Rabies virus is usually transmitted by the bite of a rabid animal (dog, bat, etc.) but can occasionally penetrate abraded skin contaminated with the saliva of infected animals. Progress of the virus after exposure is believed to follow a neural pathway, and the time between exposure and clinical rabies is a function of the proximity of the bite (or abrasion) to the central nervous system and the dose of virus injected. The incubation is usually 2 to 6 weeks but can be longer. After severe bites about the face, neck, and arms, it may be as short as 10 days. After initiation of the vaccine series (human diploid cell origin), it takes approximately one week for development of immunity to rabies; therefore, the value of immediate passive immunization with rabies antibodies in the form of Rabies Immune Globulin (Human) cannot be overemphasized. Recommendations for passive and active immunization after exposure to an animal suspected of having rabies have been outlined by the WHO (3) and by the United States Public Health Service Advisory Committee on Immunization Practices (ACIP). (1). Centers for Disease Control (CDC) recommendations were derived from data on the safety and efficacy of active and passive rabies immunization from both uncontrolled human and animal studies.</IndicationAndUsage>
<Description>Rabies Immune Globulin (Human) USP, Heat Treated, Imogam® Rabies – HT, is a sterile solution of antirabies immunoglobulin (10-16% protein) for wound infiltration and intramuscular administration. Rabies immune globulin (RIG) is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0.3 M glycine. The immune globulin solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. Imogam Rabies – HT is a clear or slightly opalescent, colorless or pale-yellow or light-brown liquid. During storage it may show formation of slight turbidity or a small amount of visible particulate matter. A heat-treatment process step (58° to 60°C, 10 hours) to inactivate viruses is used to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model laboratory strains of enveloped and non-enveloped viruses during the manufacturing and heat treatment processes for Imogam Rabies – HT have been validated by spiking experiments. Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were selected as relevant viruses for plasma derived products. Bovine viral diarrhea virus and Sindbis virus were chosen to model hepatitis C virus. Porcine pseudorabies virus was selected to model hepatitis B virus and herpes virus. Avian reovirus was used to model non-enveloped RNA viruses and for its relative resistance to inactivation by chemical and physical methods. Finally, porcine parvovirus was selected to model human parvovirus B19 and its notable resistance to inactivation by heat treatment. Removal and/or inactivation of the spiked model viruses was demonstrated at the precipitation III stage of manufacturing. In addition, inactivation was demonstrated to occur during the 10-hour (58° to 60°C) heat treatment process for the representative enveloped and non-enveloped viruses. The product is standardized against the United States (US) Standard Rabies Immune Globulin. The US unit of potency is equivalent to the International Unit (IU) for rabies antibody. The minimal potency is 150 IU/mL. The vial stopper is not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-400-20</NDCCode>
<PackageDescription>5 SYRINGE in 1 PACKAGE (49281-400-20) / .5 mL in 1 SYRINGE (49281-400-89) </PackageDescription>
<NDC11Code>49281-0400-20</NDC11Code>
<ProductNDC>49281-400</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Adacel</ProprietaryName>
<ProprietaryNameSuffix>Tdap</ProprietaryNameSuffix>
<NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20050610</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125111</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN</SubstanceName>
<StrengthNumber>5; 2; 2.5; 5; 3; 5</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adacel® is a vaccine indicated for:. Active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in individuals 10 through 64 years of age. Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.</IndicationAndUsage>
<Description>Adacel is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 5 Lf tetanus toxoid (T), 2 Lf diphtheria toxoid (d), and acellular pertussis antigens [2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL; however, Adacel is formulated with reduced quantities of diphtheria and detoxified PT. The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (2) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate. The tetanus toxin is produced from Clostridium tetani grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection. Adacel does not contain a preservative. In the guinea pig potency test, the tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of each of the FHA, PRN, and FIM acellular pertussis antigens is measured by an in vitro antigenicity enzyme-linked immunosorbent assay (ELISA). The potency of the PT acellular pertussis antigen is evaluated by the antibody response of immunized mice to detoxified PT as measured by ELISA. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.</Description>
</NDC>
<NDC>
<NDCCode>49281-618-20</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (49281-618-20) > 2.5 mL in 1 VIAL, MULTI-DOSE (49281-618-78) </PackageDescription>
<NDC11Code>49281-0618-20</NDC11Code>
<ProductNDC>49281-618</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Antigen Component</ProprietaryName>
<NonProprietaryName>Cov-2 Pres Dtm Antigen</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20201110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>COV-2 PRES DTM ANTIGEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/2.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12634-790-57</NDCCode>
<PackageDescription>20 TABLET in 1 BLISTER PACK (12634-790-57)</PackageDescription>
<NDC11Code>12634-0790-57</NDC11Code>
<ProductNDC>12634-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>12634-790-80</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (12634-790-80)</PackageDescription>
<NDC11Code>12634-0790-80</NDC11Code>
<ProductNDC>12634-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51079-790-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-790-20) > 1 TABLET in 1 BLISTER PACK (51079-790-01) </PackageDescription>
<NDC11Code>51079-0790-20</NDC11Code>
<ProductNDC>51079-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074215</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51523-790-25</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51523-790-25) > 20 g in 1 CONTAINER</PackageDescription>
<NDC11Code>51523-0790-25</NDC11Code>
<ProductNDC>51523-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Face It Aqua Uv Color Control</ProprietaryName>
<ProprietaryNameSuffix>32800790</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THEFACESHOP CO., LTD.</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.2; .8; 2.3</StrengthNumber>
<StrengthUnit>g/20g; g/20g; g/20g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71610-790-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (71610-790-20) </PackageDescription>
<NDC11Code>71610-0790-20</NDC11Code>
<ProductNDC>71610-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075468</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders. Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS:Loss of Effect). Panic Disorder. Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ and Λ containing 1 mg or 2 mg of clonazepam respectively. Each tablet also contains lactose monohydrate, polyethylene 66 67 69 glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, with the following colourants: 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>49281-252-51</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (49281-252-51) * 1 mL in 1 VIAL, SINGLE-USE (49281-246-58) * 1 mL in 1 SYRINGE (49281-263-58) </PackageDescription>
<NDC11Code>49281-0252-51</NDC11Code>
<ProductNDC>49281-252</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Imovax Rabies</ProprietaryName>
<NonProprietaryName>Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191025</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103931</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMOVAX RABIES is a vaccine indicated for the prevention of rabies in all age groups. : 1 IMOVAX RABIES is approved for pre-exposure prophylaxis to prevent rabies., 2 IMOVAX RABIES is approved for post-exposure prophylaxis to prevent rabies.</IndicationAndUsage>
<Description>IMOVAX RABIES (Rabies Vaccine) is a sterile, injectable suspension for intramuscular use. IMOVAX RABIES is supplied as a vial of lyophilized vaccine which must be reconstituted with the accompanying Sterile Water diluent. The vaccine is prepared from rabies vaccine virus strain PM-1503-3M. The vaccine virus is harvested from infected human diploid cells, MRC-5 cell line, concentrated by ultrafiltration and is inactivated by beta-propiolactone. One dose of reconstituted vaccine contains less than 100 mg human albumin, less than 150 mcg neomycin sulfate and 20 mcg of phenol red indicator. Beta-propiolactone, a residual component of the manufacturing process, is present in less than 50 parts per million. IMOVAX RABIES contains no preservative. The potency of one dose (1 mL) of IMOVAX RABIES is equal to or greater than 2.5 international units (IU) of rabies antigen. The vial stopper, the plunger rod and the tip cap of the syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-489-91</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (49281-489-91) * 5 mL in 1 VIAL, MULTI-DOSE (49281-488-78) * 6 mL in 1 VIAL (49281-466-91)</PackageDescription>
<NDC11Code>49281-0489-91</NDC11Code>
<ProductNDC>49281-489</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Menomune - A/c/y/w-135 Combined</ProprietaryName>
<NonProprietaryName>Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19811123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103926</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-01-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>49281-511-05</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (49281-511-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) </PackageDescription>
<NDC11Code>49281-0511-05</NDC11Code>
<ProductNDC>49281-511</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Pentacel</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus And Haemophilus B Conjugate (tetanus Toxoid Conjugate) Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20080620</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125145</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday).</IndicationAndUsage>
<Description>Pentacel consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® component combined through reconstitution for intramuscular use. ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB component to form Pentacel. Pentacel is a uniform, cloudy, white to off-white (yellow tinge) suspension. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)] and 10 mcg PRP of H. influenzae type b covalently bound to 24 mcg of tetanus toxoid (PRP-T). Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 42.5 mg sucrose, 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (7) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (8) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (9) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype. PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (10) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The toxoid is filter sterilized prior to the conjugation process. The ActHIB component does not contain a preservative. Potency of the ActHIB component is specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate. The vial stoppers for the DTaP-IPV and ActHIB components of Pentacel are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-562-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 PACKAGE (49281-562-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-562-58) </PackageDescription>
<NDC11Code>49281-0562-10</NDC11Code>
<ProductNDC>49281-562</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Quadracel</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125525</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>20; 5; 3; 20; 5; 15; 40; 8; 32</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).</IndicationAndUsage>
<Description>Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile suspension for intramuscular injection. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. Poliovirus Type 1, Type 2 and Type 3 are each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells, by the microcarrier method. (4) (5) The cells are grown in CMRL (Connaught Medical Research Laboratories) 1969 medium, supplemented with calf serum. For viral growth, the culture medium is replaced by Medium 199, without calf serum. After clarification and filtration, the viral suspensions are concentrated by ultrafiltration, and purified by liquid chromatography steps. The monovalent viral suspensions are inactivated with formaldehyde. Monovalent concentrates of each inactivated poliovirus are combined to produce a trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 ppm by calculation), <2 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 pg of neomycin and <4 pg polymyxin B sulfate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the inactivated poliovirus antigens is determined by measuring antibody-mediated neutralization of poliovirus in sera from immunized rats.</Description>
</NDC>
<NDC>
<NDCCode>49281-564-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-564-58) </PackageDescription>
<NDC11Code>49281-0564-10</NDC11Code>
<ProductNDC>49281-564</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Quadracel</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125525</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 5; 20; 20; 3; 5; 29; 7; 26</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).</IndicationAndUsage>
<Description>Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype.</Description>
</NDC>
<NDC>
<NDCCode>49281-564-15</NDCCode>
<PackageDescription>10 SYRINGE in 1 PACKAGE (49281-564-15) / .5 mL in 1 SYRINGE (49281-564-88) </PackageDescription>
<NDC11Code>49281-0564-15</NDC11Code>
<ProductNDC>49281-564</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Quadracel</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125525</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 5; 20; 20; 3; 5; 29; 7; 26</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<StartMarketingDatePackage>20150324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).</IndicationAndUsage>
<Description>Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], and inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)]. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate, 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the vaccine is diluted to its final concentration. Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Quadracel does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined by using an in vitro D-Antigen ELISA for each serotype.</Description>
</NDC>
<NDC>
<NDCCode>49281-620-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-620-10) / .5 mL in 1 SYRINGE (49281-620-88) </PackageDescription>
<NDC11Code>49281-0620-10</NDC11Code>
<ProductNDC>49281-620</ProductNDC>
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<ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240304</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus contained in the vaccine. Flublok is approved for use in persons 18 years of age and older.</IndicationAndUsage>
<Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-722-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-722-10) / .5 mL in 1 SYRINGE (49281-722-88) </PackageDescription>
<NDC11Code>49281-0722-10</NDC11Code>
<ProductNDC>49281-722</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Quadrivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Flublok Quadrivalent [Quadrivalent Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from four influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the four HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok Quadrivalent is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 180 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 4 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. A single 0.5 mL dose of Flublok Quadrivalent contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok Quadrivalent may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤19 mcg), baculovirus and cellular DNA (≤10 ng), and Triton X-100 (≤100 mcg). Flublok Quadrivalent contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-723-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-723-10) / .5 mL in 1 SYRINGE (49281-723-88) </PackageDescription>
<NDC11Code>49281-0723-10</NDC11Code>
<ProductNDC>49281-723</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Quadrivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/6/2021 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20230630</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230630</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Flublok Quadrivalent [Quadrivalent Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from four influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the four HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok Quadrivalent is standardized according to United States Public Health Service (USPHS) requirements. For the 2023-2024 influenza season it is formulated to contain 180 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 4 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Darwin/6/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. A single 0.5 mL dose of Flublok Quadrivalent contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok Quadrivalent may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤19 mcg), baculovirus and cellular DNA (≤10 ng), and Triton X-100 (≤100 mcg). Flublok Quadrivalent contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-724-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-724-10) / .5 mL in 1 SYRINGE (49281-724-88) </PackageDescription>
<NDC11Code>49281-0724-10</NDC11Code>
<ProductNDC>49281-724</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/massachusetts/18/2022 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/MASSACHUSETTS/18/2022 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.</IndicationAndUsage>
<Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2024-2025 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Massachusetts/18/2022 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-725-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-725-10) / .5 mL in 1 SYRINGE (49281-725-88) </PackageDescription>
<NDC11Code>49281-0725-10</NDC11Code>
<ProductNDC>49281-725</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/west Virginia/30/2022 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/district Of Columbia/27/2023 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/austria/1359417/2021 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/DISTRICT OF COLUMBIA/27/2023 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.</IndicationAndUsage>
<Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2025-2026 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/District of Columbia/27/2023 (H3N2) and B/Austria/1359417/2021. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>49281-726-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-726-10) / .5 mL in 1 SYRINGE (49281-726-88) </PackageDescription>
<NDC11Code>49281-0726-10</NDC11Code>
<ProductNDC>49281-726</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260702</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260702</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.</IndicationAndUsage>
<Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50090-7544-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-7544-0) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) </PackageDescription>
<NDC11Code>50090-7544-00</NDC11Code>
<ProductNDC>50090-7544</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Pentacel</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus And Haemophilus B Conjugate (tetanus Toxoid Conjugate) Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20080620</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125145</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday).</IndicationAndUsage>
<Description>Pentacel consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® component combined through reconstitution for intramuscular injection. ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB component to form Pentacel. Pentacel is a uniform, cloudy, white to off-white (yellow tinge) suspension. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)] and 10 mcg PRP of H. influenzae type b covalently bound to 24 mcg of tetanus toxoid (PRP-T). Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, <8.1 mcg polysorbate 80, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), 42.5 mg sucrose, 2 mcg to 7 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤10 ng residual bovine serum albumin, <0.0001 pg streptomycin sulphate, <0.01 pg of neomycin and <0.000001 pg polymyxin B sulphate. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (7) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (8) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (9) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells (a continuous line of monkey kidney cells). Prior to viral propagation, the cells are grown in Iscove's medium, supplemented with calf serum. For viral propagation, the culture medium is replaced by M199 medium without calf serum. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The potency of inactivated poliovirus antigens is determined by measuring antibody-mediated neutralization of poliovirus in sera from immunized rats. PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (10) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The toxoid is filter sterilized prior to the conjugation process. The ActHIB component does not contain a preservative. Potency of the ActHIB component is specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate. The vial stoppers for the DTaP-IPV and ActHIB components of Pentacel are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>0409-7811-37</NDCCode>
<PackageDescription>20 POUCH in 1 CASE (0409-7811-37) / 4 BAG in 1 POUCH (0409-7811-32) / 100 mL in 1 BAG (0409-7811-11) </PackageDescription>
<NDC11Code>00409-7811-37</NDC11Code>
<ProductNDC>0409-7811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050907</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018890</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Anaerobic Infections. Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. Metronidazole is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. Intra-abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus). Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. Skin and Skin Structure Infections caused by Bacteroides species including B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species. Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species. Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species. Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. Endocarditis caused by Bacteroides species including the B. fragilis group. Prophylaxis. The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION). To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole Injection, USP is a sterile, nonpyrogenic, isotonic, buffered parenteral dosage form of metronidazole in water for injection. Each 100 mL contains metronidazole 500 mg (5 mg/mL) and sodium chloride 790 mg in water for injection; with dibasic sodium phosphate (anhydrous) 48 mg and citric acid (anhydrous) 23 mg added as buffers. The osmolarity of this solution is 314 mOsmol/liter (calc.). Each 100 mL contains 14 mEq sodium, pH 5.8 (4.5 ― 7.0). Metronidazole is classified as a synthetic antibacterial and antiprotozoal agent and is administered by the intravenous route. Metronidazole, USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C6H9N3O3), a crystalline powder sparingly soluble in water. It has the following structural formula. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>10967-790-27</NDCCode>
<PackageDescription>76 g in 1 BOTTLE, WITH APPLICATOR (10967-790-27) </PackageDescription>
<NDC11Code>10967-0790-27</NDC11Code>
<ProductNDC>10967-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mitchum Ultimate- 72 Hour Protection - Wild Energy Solid - Apdeo</ProprietaryName>
<NonProprietaryName>Antiperspirant And Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Revlon Consumer Products Corp.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>20.2</StrengthNumber>
<StrengthUnit>g/76g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underam wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11712-790-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (11712-790-01)</PackageDescription>
<NDC11Code>11712-0790-01</NDC11Code>
<ProductNDC>11712-790</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pentamidine Isethionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19860723</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DELMAR CHEMICALS INC</LabelerName>
<SubstanceName>PENTAMIDINE ISETHIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24208-790-62</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-790-62) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0790-62</NDC11Code>
<ProductNDC>24208-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Gramicidin</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Gramicidin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064047</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN</SubstanceName>
<StrengthNumber>1.75; 10000; .025</StrengthNumber>
<StrengthUnit>mg/mL; [USP'U]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.</IndicationAndUsage>
<Description>Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: Actives:neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg; Inactives:sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0). Preservative:thimerosal 0.001%. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiaeWaksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are. Polymyxin B Sulfate is the sulfate salt of polymyxin B 1and B 2which are produced by the growth of Bacillus polymyxa(Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:. Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevisDubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:.</Description>
</NDC>
<NDC>
<NDCCode>36800-790-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (36800-790-10) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0790-10</NDC11Code>
<ProductNDC>36800-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TOP CARE (Topco Associates LLC)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-790-40</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE (36800-790-40) </PackageDescription>
<NDC11Code>36800-0790-40</NDC11Code>
<ProductNDC>36800-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TOP CARE (Topco Associates LLC)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-790-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42291-790-30) </PackageDescription>
<NDC11Code>42291-0790-30</NDC11Code>
<ProductNDC>42291-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204415</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Telmisartan is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc. Telmisartan tablets, USP are hygroscopic and require protection from moisture.</Description>
</NDC>
</NDCList>