{
"NDC": [
{
"NDCCode": "63361-245-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-245-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-245-58) ",
"NDC11Code": "63361-0245-10",
"ProductNDC": "63361-245",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Vaxelis",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus B Conjugate (meningococcal Protein Conjugate) And Hepatitis B (recombinant) Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20181221",
"EndMarketingDate": "20200410",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125563",
"LabelerName": "MCM Vaccine Co.",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
"StrengthNumber": "15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS],Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181221",
"EndMarketingDatePackage": "20200410",
"SamplePackage": "N"
},
{
"NDCCode": "63361-243-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-243-10) / .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58) ",
"NDC11Code": "63361-0243-10",
"ProductNDC": "63361-243",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Vaxelis",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125563",
"LabelerName": "MSP Vaccine Company",
"SubstanceName": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "20; 5; 3; 20; 5; 15; 3; 10; 29; 7; 26",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).",
"Description": "VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (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 acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The vial stopper, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex."
},
{
"NDCCode": "63361-243-15",
"PackageDescription": "10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88) ",
"NDC11Code": "63361-0243-15",
"ProductNDC": "63361-243",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Vaxelis",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125563",
"LabelerName": "MSP Vaccine Company",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
"StrengthNumber": "15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; 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], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).",
"Description": "VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (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 acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The syringe plunger stopper and syringe tip cap are not made with natural rubber latex."
},
{
"NDCCode": "0280-0056-10",
"PackageDescription": "245 mL in 1 BOTTLE, PLASTIC (0280-0056-10) ",
"NDC11Code": "00280-0056-10",
"ProductNDC": "0280-0056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold And Cough Night",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150731",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10544-245-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (10544-245-10)",
"NDC11Code": "10544-0245-10",
"ProductNDC": "10544-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076710",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients. 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, synthetic yellow iron oxide and titanium dioxide."
},
{
"NDCCode": "17271-245-03",
"PackageDescription": "10 CARTON in 1 BOX (17271-245-03) > 30 PACKAGE in 1 CARTON > 11 mL in 1 PACKAGE",
"NDC11Code": "17271-0245-03",
"ProductNDC": "17271-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bd E-z Scrub",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19950601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Becton Dickinson and Company",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19950601",
"SamplePackage": "N"
},
{
"NDCCode": "21749-368-10",
"PackageDescription": "100 PACKAGE in 1 PACKAGE (21749-368-10) / 245 mL in 1 PACKAGE",
"NDC11Code": "21749-0368-10",
"ProductNDC": "21749-368",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Hand Sanitizing Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120314",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120314",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "24658-245-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (24658-245-10)",
"NDC11Code": "24658-0245-10",
"ProductNDC": "24658-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "Blu Pharmaceuticals, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-09"
},
{
"NDCCode": "33342-245-10",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-245-10) ",
"NDC11Code": "33342-0245-10",
"ProductNDC": "33342-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207088",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to light yellowish-white powder or crystalline powder, amlodipine besylate USP, a white to off-white crystalline powder, and hydrochlorothiazide USP, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets)."
},
{
"NDCCode": "42023-245-10",
"PackageDescription": "10 BAG in 1 CARTON (42023-245-10) > 250 mL in 1 BAG",
"NDC11Code": "42023-0245-10",
"ProductNDC": "42023-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine Bitartrate",
"NonProprietaryName": "Norepinephrine In Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214628",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/250mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20230104",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5."
},
{
"NDCCode": "42571-245-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42571-245-10) ",
"NDC11Code": "42571-0245-10",
"ProductNDC": "42571-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207437",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink)."
},
{
"NDCCode": "52125-245-08",
"PackageDescription": "10 TABLET, FILM COATED in 1 VIAL (52125-245-08)",
"NDC11Code": "52125-0245-08",
"ProductNDC": "52125-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-24"
},
{
"NDCCode": "52125-245-10",
"PackageDescription": "6 TABLET, FILM COATED in 1 VIAL (52125-245-10)",
"NDC11Code": "52125-0245-10",
"ProductNDC": "52125-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-24"
},
{
"NDCCode": "55390-245-10",
"PackageDescription": "10 VIAL in 1 BOX (55390-245-10) > 5 mL in 1 VIAL",
"NDC11Code": "55390-0245-10",
"ProductNDC": "55390-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19960520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062975",
"LabelerName": "Bedford Laboratories",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-06-23"
},
{
"NDCCode": "55570-245-10",
"PackageDescription": "25 kg in 1 BOX (55570-245-10) ",
"NDC11Code": "55570-0245-10",
"ProductNDC": "55570-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ferrous Sulfate, Dried",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180418",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "FERROUS SULFATE, DRIED",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-05-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "18-APR-18"
},
{
"NDCCode": "59746-245-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59746-245-10) ",
"NDC11Code": "59746-0245-10",
"ProductNDC": "59746-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079132",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures. , 3 generalized seizures of Lennox-Gastaut syndrome. (1.1) .",
"Description": "Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is off-white to white crystalline powder. Lamotrigine is very slightly soluble in water, and slightly soluble in 0.1 M HCl. The structural formula is. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (white), 150 mg (white), and 200 mg (white) tablets. In addition, each tablet contains the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; sodium starch glycolate."
},
{
"NDCCode": "60592-245-10",
"PackageDescription": "1000 g in 1 BOTTLE (60592-245-10) ",
"NDC11Code": "60592-0245-10",
"ProductNDC": "60592-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nitrofurazone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Kalchem International inc",
"SubstanceName": "NITROFURAZONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-NOV-19"
},
{
"NDCCode": "61314-245-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "61314-0245-03",
"ProductNDC": "61314-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betaxolol Hydrochloride",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20000515",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019270",
"LabelerName": "Sandoz Inc",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "5.6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000515",
"SamplePackage": "N",
"IndicationAndUsage": "Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.",
"Description": "Betaxolol Hydrochloride Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.89. The chemical structure is presented below. Empirical Formula:. C18H29NO3HCl. Chemical Name. (±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, purified water, sodium chloride, with hydrochloric acid and/or sodium hydroxide (to adjust pH)."
},
{
"NDCCode": "62856-245-41",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (62856-245-41) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62856-0245-41",
"ProductNDC": "62856-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aricept",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020690",
"LabelerName": "Eisai Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "63187-245-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10) ",
"NDC11Code": "63187-0245-10",
"ProductNDC": "63187-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantion Macrocrystals",
"NonProprietaryName": "Nitrofurantion Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2023-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140901",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin Macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Macrocrystals is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10."
},
{
"NDCCode": "63776-245-23",
"PackageDescription": "10 mL in 1 BOTTLE (63776-245-23)",
"NDC11Code": "63776-0245-23",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "66794-245-41",
"PackageDescription": "10 VIAL in 1 CARTON (66794-245-41) / 5 mL in 1 VIAL (66794-245-02) ",
"NDC11Code": "66794-0245-41",
"ProductNDC": "66794-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215516",
"LabelerName": "PIRAMAL CRITICAL CARE INC",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium besylate injection is indicated. as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age. to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU. to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. Limitations of Use. Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.",
"Description": "Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 R-[1α, 2α (1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4- dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C 53H 72N 2O 12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C 65H 82N 2O 18S 2 and the molecular weight is 1243.49. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of. cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate Injection is between 3.0 and 3.8."
},
{
"NDCCode": "67091-245-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (67091-245-10) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "67091-0245-10",
"ProductNDC": "67091-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "WinCo Foods, LLC",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2018-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150108",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "67457-245-01",
"PackageDescription": "10 SYRINGE in 1 CARTON (67457-245-01) / 1 mL in 1 SYRINGE (67457-245-00) ",
"NDC11Code": "67457-0245-01",
"ProductNDC": "67457-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreotide Acetate",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079198",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "OCTREOTIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110401",
"SamplePackage": "N",
"IndicationAndUsage": "Octreotide acetate injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).",
"Description": "Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or intravenous (IV) injection. Octreotide acetate, known chemically as D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamidecyclic(2--7)-disulfide acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL syringes in 3 strengths, with each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate) and also contains L-lactic acid 3 mg, sodium chloride 7 mg, sodium hydroxide to adjust pH, and water for injection, q.s. L-Lactic acid and sodium hydroxide are added to provide a buffered solution, pH range 3.9 to 4.5. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
},
{
"NDCCode": "67777-245-04",
"PackageDescription": "1000 BOX in 1 CASE (67777-245-04) / 10 PACKET in 1 BOX (67777-245-14) / .55 mL in 1 PACKET",
"NDC11Code": "67777-0245-04",
"ProductNDC": "67777-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bzk Pads",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110405",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent skin infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "67777-245-16",
"PackageDescription": "1000 BOX in 1 CASE (67777-245-16) / 10 PACKET in 1 BOX (67777-245-06) / .55 mL in 1 PACKET",
"NDC11Code": "67777-0245-16",
"ProductNDC": "67777-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bzk Pads",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110405",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent skin infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "67877-245-33",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-245-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67877-0245-33",
"ProductNDC": "67877-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine 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": "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 USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light 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 iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "67877-245-38",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (67877-245-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67877-0245-38",
"ProductNDC": "67877-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine 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": "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 USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light 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 iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68382-245-78",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68382-245-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-245-30) ",
"NDC11Code": "68382-0245-78",
"ProductNDC": "68382-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210658",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210121",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRαfusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRαfusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a pale yellow to light green powder. Its molecular formula is. C29H31N7OCH4SO3 and its molecular weight is 589.7. It is freely soluble in water and sparingly soluble in methanol. Each film-coated imatinib mesylate tablet contains 100 mg or 400 mg of imatinib free base and contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone (Type A), hypromellose, magnesium stearate, mannitol and microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "68462-245-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-245-10)",
"NDC11Code": "68462-0245-10",
"ProductNDC": "68462-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090169",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
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<NDC>
<NDCCode>63361-245-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-245-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-245-58) </PackageDescription>
<NDC11Code>63361-0245-10</NDC11Code>
<ProductNDC>63361-245</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaxelis</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus B Conjugate (meningococcal Protein Conjugate) And Hepatitis B (recombinant) Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<EndMarketingDate>20200410</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125563</ApplicationNumber>
<LabelerName>MCM Vaccine Co.</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN</SubstanceName>
<StrengthNumber>15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS],Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<EndMarketingDatePackage>20200410</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63361-243-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-243-10) / .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58) </PackageDescription>
<NDC11Code>63361-0243-10</NDC11Code>
<ProductNDC>63361-243</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaxelis</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125563</ApplicationNumber>
<LabelerName>MSP Vaccine Company</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>20; 5; 3; 20; 5; 15; 3; 10; 29; 7; 26</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).</IndicationAndUsage>
<Description>VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (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 acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The vial stopper, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>63361-243-15</NDCCode>
<PackageDescription>10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88) </PackageDescription>
<NDC11Code>63361-0243-15</NDC11Code>
<ProductNDC>63361-243</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaxelis</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125563</ApplicationNumber>
<LabelerName>MSP Vaccine Company</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN</SubstanceName>
<StrengthNumber>15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).</IndicationAndUsage>
<Description>VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (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 acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The syringe plunger stopper and syringe tip cap are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>0280-0056-10</NDCCode>
<PackageDescription>245 mL in 1 BOTTLE, PLASTIC (0280-0056-10) </PackageDescription>
<NDC11Code>00280-0056-10</NDC11Code>
<ProductNDC>0280-0056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold And Cough Night</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<EndMarketingDate>20180531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10544-245-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (10544-245-10)</PackageDescription>
<NDC11Code>10544-0245-10</NDC11Code>
<ProductNDC>10544-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076710</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients. 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, synthetic yellow iron oxide and titanium dioxide.</Description>
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<PackageDescription>10 CARTON in 1 BOX (17271-245-03) > 30 PACKAGE in 1 CARTON > 11 mL in 1 PACKAGE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bd E-z Scrub</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Becton Dickinson and Company</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<ProductNDC>21749-368</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Hand Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
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<PackageDescription>1000 TABLET in 1 BOTTLE (24658-245-10)</PackageDescription>
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<ProductNDC>24658-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>Blu Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-09</LastUpdate>
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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-245-10) </PackageDescription>
<NDC11Code>33342-0245-10</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</NonProprietaryName>
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<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207088</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
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<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to light yellowish-white powder or crystalline powder, amlodipine besylate USP, a white to off-white crystalline powder, and hydrochlorothiazide USP, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).</Description>
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<PackageDescription>10 BAG in 1 CARTON (42023-245-10) > 250 mL in 1 BAG</PackageDescription>
<NDC11Code>42023-0245-10</NDC11Code>
<ProductNDC>42023-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine Bitartrate</ProprietaryName>
<NonProprietaryName>Norepinephrine In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214628</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/250mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5.</Description>
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<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
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<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207437</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
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<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C 29H 30N 6O 6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine, hydrochlorothiazide tablet is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white to almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odorless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; slightly soluble in water; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acid. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients. 20 /5 /12.5 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide black, iron oxide red and iron oxide yellow (opadry II white). 40 /5 /12.5 mg and 40 /5 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide yellow (opadry II yellow). 40 /10 /12.5 mg and 40 /10 /25 mg-silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol 3350, talc, iron oxide yellow and iron oxide red (opadry II pink).</Description>
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<ProprietaryName>Ciprofloxacin</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
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<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-245-10</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 VIAL (52125-245-10)</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>55390-245-10</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (55390-245-10) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>55390-0245-10</NDC11Code>
<ProductNDC>55390-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19960520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062975</ApplicationNumber>
<LabelerName>Bedford Laboratories</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-06-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>55570-245-10</NDCCode>
<PackageDescription>25 kg in 1 BOX (55570-245-10) </PackageDescription>
<NDC11Code>55570-0245-10</NDC11Code>
<ProductNDC>55570-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ferrous Sulfate, Dried</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180418</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>FERROUS SULFATE, DRIED</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59746-245-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59746-245-10) </PackageDescription>
<NDC11Code>59746-0245-10</NDC11Code>
<ProductNDC>59746-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079132</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic seizures. , 3 generalized seizures of Lennox-Gastaut syndrome. (1.1) .</IndicationAndUsage>
<Description>Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is off-white to white crystalline powder. Lamotrigine is very slightly soluble in water, and slightly soluble in 0.1 M HCl. The structural formula is. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (white), 150 mg (white), and 200 mg (white) tablets. In addition, each tablet contains the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>60592-245-10</NDCCode>
<PackageDescription>1000 g in 1 BOTTLE (60592-245-10) </PackageDescription>
<NDC11Code>60592-0245-10</NDC11Code>
<ProductNDC>60592-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nitrofurazone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Kalchem International inc</LabelerName>
<SubstanceName>NITROFURAZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-NOV-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61314-245-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61314-0245-03</NDC11Code>
<ProductNDC>61314-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betaxolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20000515</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019270</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5.6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.</IndicationAndUsage>
<Description>Betaxolol Hydrochloride Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.89. The chemical structure is presented below. Empirical Formula:. C18H29NO3HCl. Chemical Name. (±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride. Each mL contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, purified water, sodium chloride, with hydrochloric acid and/or sodium hydroxide (to adjust pH).</Description>
</NDC>
<NDC>
<NDCCode>62856-245-41</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (62856-245-41) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62856-0245-41</NDC11Code>
<ProductNDC>62856-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aricept</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020690</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-245-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10) </PackageDescription>
<NDC11Code>63187-0245-10</NDC11Code>
<ProductNDC>63187-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantion Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantion Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin Macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Macrocrystals is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>63776-245-23</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (63776-245-23)</PackageDescription>
<NDC11Code>63776-0245-23</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66794-245-41</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (66794-245-41) / 5 mL in 1 VIAL (66794-245-02) </PackageDescription>
<NDC11Code>66794-0245-41</NDC11Code>
<ProductNDC>66794-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215516</ApplicationNumber>
<LabelerName>PIRAMAL CRITICAL CARE INC</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium besylate injection is indicated. as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age. to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU. to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. Limitations of Use. Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.</IndicationAndUsage>
<Description>Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 R-[1α, 2α (1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4- dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C 53H 72N 2O 12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C 65H 82N 2O 18S 2 and the molecular weight is 1243.49. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of. cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate Injection is between 3.0 and 3.8.</Description>
</NDC>
<NDC>
<NDCCode>67091-245-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (67091-245-10) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67091-0245-10</NDC11Code>
<ProductNDC>67091-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>WinCo Foods, LLC</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67457-245-01</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (67457-245-01) / 1 mL in 1 SYRINGE (67457-245-00) </PackageDescription>
<NDC11Code>67457-0245-01</NDC11Code>
<ProductNDC>67457-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Octreotide Acetate</ProprietaryName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079198</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Octreotide acetate injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).</IndicationAndUsage>
<Description>Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or intravenous (IV) injection. Octreotide acetate, known chemically as D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamidecyclic(2--7)-disulfide acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL syringes in 3 strengths, with each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate) and also contains L-lactic acid 3 mg, sodium chloride 7 mg, sodium hydroxide to adjust pH, and water for injection, q.s. L-Lactic acid and sodium hydroxide are added to provide a buffered solution, pH range 3.9 to 4.5. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
</NDC>
<NDC>
<NDCCode>67777-245-04</NDCCode>
<PackageDescription>1000 BOX in 1 CASE (67777-245-04) / 10 PACKET in 1 BOX (67777-245-14) / .55 mL in 1 PACKET</PackageDescription>
<NDC11Code>67777-0245-04</NDC11Code>
<ProductNDC>67777-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bzk Pads</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67777-245-16</NDCCode>
<PackageDescription>1000 BOX in 1 CASE (67777-245-16) / 10 PACKET in 1 BOX (67777-245-06) / .55 mL in 1 PACKET</PackageDescription>
<NDC11Code>67777-0245-16</NDC11Code>
<ProductNDC>67777-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bzk Pads</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67877-245-33</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (67877-245-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0245-33</NDC11Code>
<ProductNDC>67877-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine 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).</IndicationAndUsage>
<Description>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 USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light 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 iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>67877-245-38</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (67877-245-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0245-38</NDC11Code>
<ProductNDC>67877-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine 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).</IndicationAndUsage>
<Description>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 USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light 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 iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68382-245-78</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68382-245-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-245-30) </PackageDescription>
<NDC11Code>68382-0245-78</NDC11Code>
<ProductNDC>68382-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210658</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRαfusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRαfusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a pale yellow to light green powder. Its molecular formula is. C29H31N7OCH4SO3 and its molecular weight is 589.7. It is freely soluble in water and sparingly soluble in methanol. Each film-coated imatinib mesylate tablet contains 100 mg or 400 mg of imatinib free base and contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone (Type A), hypromellose, magnesium stearate, mannitol and microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-245-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-245-10)</PackageDescription>
<NDC11Code>68462-0245-10</NDC11Code>
<ProductNDC>68462-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090169</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>