RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "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": "25021-252-51",
      "PackageDescription": "1 VIAL in 1 CARTON (25021-252-51)  / 80 mL in 1 VIAL",
      "NDC11Code": "25021-0252-51",
      "ProductNDC": "25021-252",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mitomycin",
      "NonProprietaryName": "Mitomycin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216648",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "MITOMYCIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/80mL",
      "Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.",
      "Description": "Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. Each Single-Dose vial contains mitomycin 40 mg and mannitol 80 mg. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;."
    },
    {
      "NDCCode": "49281-250-51",
      "PackageDescription": "1 KIT in 1 PACKAGE (49281-250-51)  *  1 mL in 1 VIAL, SINGLE-USE (49281-248-58)  *  1 mL in 1 SYRINGE (49281-249-01) ",
      "NDC11Code": "49281-0250-51",
      "ProductNDC": "49281-250",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Imovax Rabies",
      "NonProprietaryName": "Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19800609",
      "EndMarketingDate": "20211207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103931",
      "LabelerName": "Sanofi Pasteur Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19800609",
      "EndMarketingDatePackage": "20211207",
      "SamplePackage": "N"
    },
    {
      "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": "61269-252-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (61269-252-10) ",
      "NDC11Code": "61269-0252-10",
      "ProductNDC": "61269-252",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Seroquel",
      "NonProprietaryName": "Quetiapine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19971001",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020639",
      "LabelerName": "H2-Pharma, LLC",
      "SubstanceName": "QUETIAPINE FUMARATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19971001",
      "SamplePackage": "N",
      "IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
      "Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
    },
    {
      "NDCCode": "69452-125-51",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69452-125-51)  / 250 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "69452-0125-51",
      "ProductNDC": "69452-125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxcarbazepine",
      "NonProprietaryName": "Oxcarbazepine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209652",
      "LabelerName": "Bionpharma Inc.",
      "SubstanceName": "OXCARBAZEPINE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
      "Description": "Oxcarbazepine, USP is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5 H­ dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine, USP is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: ascorbic acid; methylparaben; microcrystalline cellulose and carboxymethylcellulose sodium; polyoxyl stearate; propylene glycol; propylparaben; purified water; sodium saccharin; sorbic acid; sorbitol solution; and xanthan gum."
    },
    {
      "NDCCode": "49281-013-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-013-10)  > .5 mL in 1 VIAL, SINGLE-DOSE (49281-013-58)",
      "NDC11Code": "49281-0013-10",
      "ProductNDC": "49281-013",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-013-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50)  > .5 mL in 1 SYRINGE, GLASS (49281-013-88)",
      "NDC11Code": "49281-0013-50",
      "ProductNDC": "49281-013",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-014-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-014-50)  > .5 mL in 1 SYRINGE, GLASS (49281-014-88)",
      "NDC11Code": "49281-0014-50",
      "ProductNDC": "49281-014",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140627",
      "EndMarketingDate": "20150630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "49281-016-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50)  / .5 mL in 1 SYRINGE, GLASS (49281-016-88) ",
      "NDC11Code": "49281-0016-50",
      "ProductNDC": "49281-016",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Hd Tiv Sh 2026",
      "NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260220",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260220",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-026-50",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) ",
      "NDC11Code": "49281-0026-50",
      "ProductNDC": "49281-026",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Nuvaxovid 2026-27",
      "NonProprietaryName": "Nvx-cov2928",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260827",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125817",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "NVX-COV2928",
      "StrengthNumber": "5",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260827",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
      "Description": "NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), Tergitol (NP9) (< 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-113-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-113-25)  > .25 mL in 1 SYRINGE, GLASS (49281-113-00)",
      "NDC11Code": "49281-0113-25",
      "ProductNDC": "49281-113",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-116-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-116-25)  > .25 mL in 1 SYRINGE, GLASS (49281-116-00)",
      "NDC11Code": "49281-0116-25",
      "ProductNDC": "49281-116",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20160324",
      "EndMarketingDate": "20161231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-05"
    },
    {
      "NDCCode": "49281-120-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-120-65)  / .7 mL in 1 SYRINGE, GLASS (49281-120-88) ",
      "NDC11Code": "49281-0120-65",
      "ProductNDC": "49281-120",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200702",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-121-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-121-65)  / .7 mL in 1 SYRINGE, GLASS (49281-121-88) ",
      "NDC11Code": "49281-0121-65",
      "ProductNDC": "49281-121",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210702",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-122-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-122-65)  / .7 mL in 1 SYRINGE, GLASS (49281-122-88) ",
      "NDC11Code": "49281-0122-65",
      "ProductNDC": "49281-122",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-123-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-123-65)  / .7 mL in 1 SYRINGE, GLASS (49281-123-88) ",
      "NDC11Code": "49281-0123-65",
      "ProductNDC": "49281-123",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230630",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Fluzone High-Dose Quadrivalent suspension for injection is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-124-65",
      "PackageDescription": "5 SYRINGE, GLASS in 1 PACKAGE (49281-124-65)  / .5 mL in 1 SYRINGE, GLASS (49281-124-88) ",
      "NDC11Code": "49281-0124-65",
      "ProductNDC": "49281-124",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High Dose Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240701",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240701",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose. The Fluzone High-Dose prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2024–2025 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/California/122/2022 SAN-022 (an A/Thailand/8/2022-like virus) (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-125-65",
      "PackageDescription": "5 SYRINGE, GLASS in 1 PACKAGE (49281-125-65)  / .5 mL in 1 SYRINGE, GLASS (49281-125-88) ",
      "NDC11Code": "49281-0125-65",
      "ProductNDC": "49281-125",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High Dose Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250701",
      "EndMarketingDate": "20260630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250701",
      "EndMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose. The Fluzone High-Dose prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2025–2026 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-126-65",
      "PackageDescription": "5 SYRINGE, GLASS in 1 PACKAGE (49281-126-65)  / .5 mL in 1 SYRINGE, GLASS (49281-126-88) ",
      "NDC11Code": "49281-0126-65",
      "ProductNDC": "49281-126",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High Dose Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (a/missouri/11/2025 Pdm09-like Virus) (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260702",
      "EndMarketingDate": "20270630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260702",
      "EndMarketingDatePackage": "20270630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose. The Fluzone High-Dose prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose is formulated to contain HA of each of the following three influenza strains recommended for the 2026-2027 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Michigan/105/2025 SAN-049A (A/Darwin/1454/2025-like virus) (H3N2), and B/Tokyo/EIS13-175/2025 (B Victoria lineage). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-181-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-181-25)  > .25 mL in 1 SYRINGE, GLASS (49281-181-00) ",
      "NDC11Code": "49281-0181-25",
      "ProductNDC": "49281-181",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190930",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190930",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-182-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-182-25)  > .25 mL in 1 SYRINGE, GLASS (49281-182-00) ",
      "NDC11Code": "49281-0182-25",
      "ProductNDC": "49281-182",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210204",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210204",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-183-71",
      "PackageDescription": "1 TUBE in 1 BOX (49281-183-71)  > 117 g in 1 TUBE",
      "NDC11Code": "49281-0183-71",
      "ProductNDC": "49281-183",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sklice",
      "NonProprietaryName": "Ivermectin",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120709",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202736",
      "LabelerName": "Sanofi Pasteur, Inc",
      "SubstanceName": "IVERMECTIN",
      "StrengthNumber": ".585",
      "StrengthUnit": "g/117g",
      "Pharm_Classes": "Antiparasitic [EPC],Pediculicide [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "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": "49281-215-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10)  / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58) ",
      "NDC11Code": "49281-0215-10",
      "ProductNDC": "49281-215",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Tenivac",
      "NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20101208",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103171",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "5; 2",
      "StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101208",
      "SamplePackage": "N",
      "IndicationAndUsage": "TENIVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.",
      "Description": "TENIVAC, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate. Each 0.5 mL dose of TENIVAC contains the following active ingredients. Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde. Clostridium tetani is 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. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate. The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative. In the guinea pig potency test, the tetanus toxoid component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum. The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex."
    },
    {
      "NDCCode": "49281-215-15",
      "PackageDescription": "10 SYRINGE in 1 PACKAGE (49281-215-15)  / .5 mL in 1 SYRINGE (49281-215-88) ",
      "NDC11Code": "49281-0215-15",
      "ProductNDC": "49281-215",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Tenivac",
      "NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20101208",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103171",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "5; 2",
      "StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101208",
      "SamplePackage": "N",
      "IndicationAndUsage": "TENIVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.",
      "Description": "TENIVAC, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate. Each 0.5 mL dose of TENIVAC contains the following active ingredients. Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde. Clostridium tetani is 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. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate. The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative. In the guinea pig potency test, the tetanus toxoid component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum. The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex."
    },
    {
      "NDCCode": "49281-224-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-224-65)  / .7 mL in 1 SYRINGE, GLASS (49281-224-88) ",
      "NDC11Code": "49281-0224-65",
      "ProductNDC": "49281-224",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240701",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240701",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher HA antigen concentration. Fluzone High-Dose Quadrivalent is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2024-2025 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/California/122/2022 SAN-022 (an A/Thailand/8/2022-like virus) (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-225-10",
      "PackageDescription": "10 VIAL in 1 PACKAGE (49281-225-10)  > .5 mL in 1 VIAL (49281-225-58) ",
      "NDC11Code": "49281-0225-10",
      "ProductNDC": "49281-225",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Diphtheria And Tetanus Toxoids Adsorbed",
      "NonProprietaryName": "Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20100329",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103944",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "5; 25",
      "StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated. Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.",
      "Description": "Diphtheria and Tetanus Toxoids Adsorbed is a sterile, cloudy, white, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution for intramuscular injection only. Diphtheria and Tetanus Toxoids Adsorbed vaccine does not contain a preservative. Each 0.5 mL dose is formulated to contain: 25 Lf diphtheria toxoid and 5 Lf tetanus toxoid. Other ingredients per 0.5 mL dose include: 1.5 mg aluminum phosphate and <100 mcg free formaldehyde. Diphtheria toxoid is prepared from the toxin produced during the growth of a selected strain of Corynebacterium diphtheriae grown with aeration in submerged culture. The toxin is purified by precipitation, converted to toxoid by the addition of formalin and concentrated by ultrafiltration. The culture medium consists of a tryptic digest of casein, supplemented with cystine, maltose, uracil, inorganic salts and vitamins. Tetanus toxoid is prepared from the toxin produced during the growth of a selected strain of Clostridium tetani. The toxin is converted to toxoid by the addition of formalin, concentrated and then purified. The culture medium consists of a tryptic digest of casein, supplemented with cystine, dextrose, uracil, inorganic salts and vitamins. When tested in guinea pigs, the tetanus and diphtheria components induce at least 2 neutralizing units/mL of serum. The vial stopper is not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-226-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-226-65)  / .7 mL in 1 SYRINGE, GLASS (49281-226-88) ",
      "NDC11Code": "49281-0226-65",
      "ProductNDC": "49281-226",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250701",
      "EndMarketingDate": "20260630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250701",
      "EndMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher HA antigen concentration. The purified split virus from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone High-Dose Quadrivalent is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2025-2026 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-286-01",
      "PackageDescription": "1 VIAL in 1 PACKAGE (49281-286-01)  / .5 mL in 1 VIAL (49281-286-58) ",
      "NDC11Code": "49281-0286-01",
      "ProductNDC": "49281-286",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Daptacel",
      "NonProprietaryName": "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, And Bordetella Pertussis Fimbriae 2/3 Antigen",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20020514",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103666",
      "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",
      "StrengthNumber": "15; 5; 10; 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": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020514",
      "SamplePackage": "N",
      "IndicationAndUsage": "DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).",
      "Description": "DAPTACEL is a sterile isotonic injectable suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular use. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), and 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of 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 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. The FIM components are extracted and co-purified 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. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (4) 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 adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection. The potency of tetanus and diphtheria toxoids is measured by in vitro antigenicity enzyme-linked immunosorbent assays (ELISAs), which detect immunologically relevant epitopes. The potency of the acellular pertussis vaccine components is determined by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by ELISA."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49281-252-51","ProprietaryName":"Imovax Rabies","NonProprietaryName":"Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water"},{"NDCCode":"25021-252-51","ProprietaryName":"Mitomycin","NonProprietaryName":"Mitomycin"},{"NDCCode":"49281-250-51","ProprietaryName":"Imovax Rabies","NonProprietaryName":"Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water"},{"NDCCode":"49281-790-51","ProprietaryName":"Typhim Vi","NonProprietaryName":"Salmonella Typhi Ty2 Vi Polysaccharide Antigen"},{"NDCCode":"61269-252-10","ProprietaryName":"Seroquel","NonProprietaryName":"Quetiapine"},{"NDCCode":"69452-125-51","ProprietaryName":"Oxcarbazepine","NonProprietaryName":"Oxcarbazepine"},{"NDCCode":"49281-013-10","ProprietaryName":"Fluzone","NonProprietaryName":"Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-013-50","ProprietaryName":"Fluzone","NonProprietaryName":"Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-014-50","ProprietaryName":"Fluzone","NonProprietaryName":"Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-016-50","ProprietaryName":"Fluzone Hd Tiv Sh 2026","NonProprietaryName":"Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-026-50","ProprietaryName":"Nuvaxovid 2026-27","NonProprietaryName":"Nvx-cov2928"},{"NDCCode":"49281-113-25","ProprietaryName":"Fluzone","NonProprietaryName":"Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-116-25","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-120-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-121-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-122-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-123-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-124-65","ProprietaryName":"Fluzone High Dose Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-125-65","ProprietaryName":"Fluzone High Dose Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-126-65","ProprietaryName":"Fluzone High Dose Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/switzerland/6849/2025 Ivr-278 (a/missouri/11/2025 Pdm09-like Virus) (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-181-25","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-182-25","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-183-71","ProprietaryName":"Sklice","NonProprietaryName":"Ivermectin"},{"NDCCode":"49281-190-20","ProprietaryName":"Imogam Rabies-ht","NonProprietaryName":"Human Rabies Virus Immune Globulin"},{"NDCCode":"49281-215-10","ProprietaryName":"Tenivac","NonProprietaryName":"Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-215-15","ProprietaryName":"Tenivac","NonProprietaryName":"Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-224-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-225-10","ProprietaryName":"Diphtheria And Tetanus Toxoids Adsorbed","NonProprietaryName":"Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-226-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-286-01","ProprietaryName":"Daptacel","NonProprietaryName":"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, And Bordetella Pertussis Fimbriae 2/3 Antigen"}]}
                    

<NDCList><NDC><NDCCode>49281-252-51</NDCCode><ProprietaryName>Imovax Rabies</ProprietaryName><NonProprietaryName>Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water</NonProprietaryName></NDC><NDC><NDCCode>25021-252-51</NDCCode><ProprietaryName>Mitomycin</ProprietaryName><NonProprietaryName>Mitomycin</NonProprietaryName></NDC><NDC><NDCCode>49281-250-51</NDCCode><ProprietaryName>Imovax Rabies</ProprietaryName><NonProprietaryName>Rabies Virus Strain Pm-1503-3m Antigen (propiolactone Inactivated) And Water</NonProprietaryName></NDC><NDC><NDCCode>49281-790-51</NDCCode><ProprietaryName>Typhim Vi</ProprietaryName><NonProprietaryName>Salmonella Typhi Ty2 Vi Polysaccharide Antigen</NonProprietaryName></NDC><NDC><NDCCode>61269-252-10</NDCCode><ProprietaryName>Seroquel</ProprietaryName><NonProprietaryName>Quetiapine</NonProprietaryName></NDC><NDC><NDCCode>69452-125-51</NDCCode><ProprietaryName>Oxcarbazepine</ProprietaryName><NonProprietaryName>Oxcarbazepine</NonProprietaryName></NDC><NDC><NDCCode>49281-013-10</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-013-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-014-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-016-50</NDCCode><ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName><NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-026-50</NDCCode><ProprietaryName>Nuvaxovid 2026-27</ProprietaryName><NonProprietaryName>Nvx-cov2928</NonProprietaryName></NDC><NDC><NDCCode>49281-113-25</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-116-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-120-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-121-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-122-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-123-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-124-65</NDCCode><ProprietaryName>Fluzone High Dose Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-125-65</NDCCode><ProprietaryName>Fluzone High Dose Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-126-65</NDCCode><ProprietaryName>Fluzone High Dose Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (a/missouri/11/2025 Pdm09-like Virus) (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-181-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-182-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-183-71</NDCCode><ProprietaryName>Sklice</ProprietaryName><NonProprietaryName>Ivermectin</NonProprietaryName></NDC><NDC><NDCCode>49281-190-20</NDCCode><ProprietaryName>Imogam Rabies-ht</ProprietaryName><NonProprietaryName>Human Rabies Virus Immune Globulin</NonProprietaryName></NDC><NDC><NDCCode>49281-215-10</NDCCode><ProprietaryName>Tenivac</ProprietaryName><NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-215-15</NDCCode><ProprietaryName>Tenivac</ProprietaryName><NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-224-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-225-10</NDCCode><ProprietaryName>Diphtheria And Tetanus Toxoids Adsorbed</ProprietaryName><NonProprietaryName>Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-226-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-286-01</NDCCode><ProprietaryName>Daptacel</ProprietaryName><NonProprietaryName>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, And Bordetella Pertussis Fimbriae 2/3 Antigen</NonProprietaryName></NDC></NDCList>