RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "72936-010-88",
      "PackageDescription": "1 TUBE in 1 CARTON (72936-010-88)  / 88.7 g in 1 TUBE",
      "NDC11Code": "72936-0010-88",
      "ProductNDC": "72936-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "NonProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210621",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M020",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "6.9; 3; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210621",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn.  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "72936-010-75",
      "PackageDescription": "1 TUBE in 1 CARTON (72936-010-75)  > 75 g in 1 TUBE",
      "NDC11Code": "72936-0010-75",
      "ProductNDC": "72936-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "NonProprietaryName": "Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "6.9; 3; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190309",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71977-010-03",
      "PackageDescription": "88.72 mL in 1 CONTAINER (71977-010-03) ",
      "NDC11Code": "71977-0010-03",
      "ProductNDC": "71977-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daredevil Strength Muscle And Arthritis Pain Relieving Roll On",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181025",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "DDR Products, LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20181025",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80808-010-98",
      "PackageDescription": "24 CANISTER in 1 CARTON (80808-010-98)  > 80 PATCH in 1 CANISTER (80808-010-88)  > 5 mL in 1 PATCH (80808-010-80) ",
      "NDC11Code": "80808-0010-98",
      "ProductNDC": "80808-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hygenize Alcohol Wipes",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "PATCH",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20201004",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Hygenize Corp.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201004",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83254-010-88",
      "PackageDescription": "88 mL in 1 BOTTLE (83254-010-88) ",
      "NDC11Code": "83254-0010-88",
      "ProductNDC": "83254-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nanz Povidone Iodine 10% Solution",
      "NonProprietaryName": "Povidone Iodine 10% Solution",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230208",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "M005",
      "LabelerName": "1201258 Ontario Inc Nanz Pharma",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230312",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84178-010-01",
      "PackageDescription": "88.5 g in 1 BOTTLE, WITH APPLICATOR (84178-010-01) ",
      "NDC11Code": "84178-0010-01",
      "ProductNDC": "84178-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanar Natural-arnica Roll On",
      "ProprietaryNameSuffix": "Arnica Pain Relieving With Camphor",
      "NonProprietaryName": "Evi Labs",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20250123",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "EVI LABS",
      "SubstanceName": "CAMPHOR (SYNTHETIC)",
      "StrengthNumber": ".885",
      "StrengthUnit": "g/88.5g",
      "Status": "Active",
      "LastUpdate": "2025-02-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250123",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints.",
      "Description": "Directions: Adults and Children over 12 years Apply to affected area not more than 3 or 4 times daily. Childen under 12 years Do not use, consult a Doctor."
    },
    {
      "NDCCode": "16590-010-20",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (16590-010-20)",
      "NDC11Code": "16590-0010-20",
      "ProductNDC": "16590-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambien",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019908",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
    },
    {
      "NDCCode": "16590-010-28",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (16590-010-28)",
      "NDC11Code": "16590-0010-28",
      "ProductNDC": "16590-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambien",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019908",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
    },
    {
      "NDCCode": "16590-010-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-010-30)",
      "NDC11Code": "16590-0010-30",
      "ProductNDC": "16590-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambien",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019908",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
    },
    {
      "NDCCode": "16590-010-56",
      "PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (16590-010-56)",
      "NDC11Code": "16590-0010-56",
      "ProductNDC": "16590-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambien",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019908",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
    },
    {
      "NDCCode": "43066-010-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (43066-010-01)  / 16 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "43066-0010-01",
      "ProductNDC": "43066-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Docetaxel",
      "NonProprietaryName": "Docetaxel",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180219",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA201525",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DOCETAXEL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
      "Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80."
    },
    {
      "NDCCode": "49281-122-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-122-65)  / .7 mL in 1 SYRINGE, GLASS (49281-122-88) ",
      "NDC11Code": "49281-0122-65",
      "ProductNDC": "49281-122",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-123-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-123-65)  / .7 mL in 1 SYRINGE, GLASS (49281-123-88) ",
      "NDC11Code": "49281-0123-65",
      "ProductNDC": "49281-123",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230630",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Fluzone High-Dose Quadrivalent suspension for injection is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-312-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-312-50)  / .5 mL in 1 SYRINGE, GLASS (49281-312-88) ",
      "NDC11Code": "49281-0312-50",
      "ProductNDC": "49281-312",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240304",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240304",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-322-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-322-50)  > .5 mL in 1 SYRINGE, GLASS (49281-322-88) ",
      "NDC11Code": "49281-0322-50",
      "ProductNDC": "49281-322",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220215",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220215",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-323-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-323-50)  / .5 mL in 1 SYRINGE, GLASS (49281-323-88) ",
      "NDC11Code": "49281-0323-50",
      "ProductNDC": "49281-323",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230213",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SYDNEY/5/2021 SAN-013 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230213",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-379-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-379-50)  / .7 mL in 1 SYRINGE, GLASS (49281-379-88) ",
      "NDC11Code": "49281-0379-50",
      "ProductNDC": "49281-379",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230213",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SYDNEY/5/2021 SAN-013 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230213",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-418-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-418-50)  / .5 mL in 1 SYRINGE, GLASS (49281-418-88) ",
      "NDC11Code": "49281-0418-50",
      "ProductNDC": "49281-418",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190123",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-420-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-420-50)  / .5 mL in 1 SYRINGE, GLASS (49281-420-88) ",
      "NDC11Code": "49281-0420-50",
      "ProductNDC": "49281-420",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200702",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-421-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-421-50)  / .5 mL in 1 SYRINGE, GLASS (49281-421-88) ",
      "NDC11Code": "49281-0421-50",
      "ProductNDC": "49281-421",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210702",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-422-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-422-50)  / .5 mL in 1 SYRINGE, GLASS (49281-422-88) ",
      "NDC11Code": "49281-0422-50",
      "ProductNDC": "49281-422",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-423-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-423-50)  / .5 mL in 1 SYRINGE, GLASS (49281-423-88) ",
      "NDC11Code": "49281-0423-50",
      "ProductNDC": "49281-423",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230630",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-467-65",
      "PackageDescription": "5 SYRINGE, GLASS in 1 PACKAGE (49281-467-65)  / .5 mL in 1 SYRINGE, GLASS (49281-467-88) ",
      "NDC11Code": "49281-0467-65",
      "ProductNDC": "49281-467",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High Dose Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240304",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240304",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose. The Fluzone High-Dose prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "61315-010-01",
      "PackageDescription": "30 mL in 1 CARTON (61315-010-01)",
      "NDC11Code": "61315-0010-01",
      "ProductNDC": "61315-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arllin Golden Combination Charisma Cc",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Golden Bridge International",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "2.9; 1.5; .88",
      "StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Indications and Usage:1. Tighten the lid after using it.2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3. Use it after basic skin care."
    },
    {
      "NDCCode": "69894-010-01",
      "PackageDescription": "160 mL in 1 CARTON (69894-010-01)",
      "NDC11Code": "69894-0010-01",
      "ProductNDC": "69894-010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Co2 Carbonic Body Fit",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150501",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "WOW VENTURES",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "6.88",
      "StrengthUnit": "mg/160mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-29"
    },
    {
      "NDCCode": "83703-044-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (83703-044-50)  / .5 mL in 1 SYRINGE, GLASS (83703-044-88) ",
      "NDC11Code": "83703-0044-50",
      "ProductNDC": "83703-044",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Bamboo US BidCo LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72936-020-04",
      "PackageDescription": "1 TUBE in 1 CARTON (72936-020-04)  > 4 g in 1 TUBE",
      "NDC11Code": "72936-0020-04",
      "ProductNDC": "72936-020",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Make Out Ready Moisturizing Lip Balm Spf 15",
      "NonProprietaryName": "Higher Education Make Out Ready Moisturizing Lip Balm Spf 15",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "2; 4.5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190309",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn."
    },
    {
      "NDCCode": "72936-030-60",
      "PackageDescription": "60 PATCH in 1 CARTON (72936-030-60)  > 60 g in 1 PATCH",
      "NDC11Code": "72936-0030-60",
      "ProductNDC": "72936-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid",
      "NonProprietaryName": "Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Higher Education Skincare, LLC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190309",
      "SamplePackage": "N",
      "IndicationAndUsage": " for the management of acne   reduces the severity of oiliness and smooths complexion   helps prevent the development of new acne blemishes."
    },
    {
      "NDCCode": "72936-777-15",
      "PackageDescription": "5 g in 1 TUBE (72936-777-15) ",
      "NDC11Code": "72936-0777-15",
      "ProductNDC": "72936-777",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Spf15 Sunscreen Lip Balm",
      "NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Octocrylene",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210401",
      "EndMarketingDate": "20250706",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "HIGHER EDUCATION SKINCARE, LLC",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 7.5; 5; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210401",
      "EndMarketingDatePackage": "20250706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use helps prevent sunburn."
    },
    {
      "NDCCode": "0254-2000-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2000-01) ",
      "NDC11Code": "00254-2000-01",
      "ProductNDC": "0254-2000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penicillamine",
      "NonProprietaryName": "Penicillamine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211196",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "PENICILLAMINE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antirheumatic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Penicillamine tablets are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine tablets are not of value in ankylosing spondylitis. Wilson’s Disease - Wilson’s disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. The metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal. As a result, copper is deposited in several organs and appears eventually to produce pathologic effects most prominently seen in the brain, where degeneration is widespread; in the liver, where fatty infiltration, inflammation, and hepatocellular damage progress to postnecrotic cirrhosis; in the kidney, where tubular and glomerular dysfunction results; and in the eye, where characteristic corneal copper deposits are known as Kayser-Fleischer rings. Two types of patients require treatment for Wilson’s disease: (1) the symptomatic, and (2) the asymptomatic in whom it can be assumed the disease will develop in the future if the patient is not treated. Diagnosis, suspected on the basis of family or individual history, physical examination, or a low serum concentration of ceruloplasmin*, is confirmed by the demonstration of Kayser-Fleischer rings or, particularly in the asymptomatic patient, by the quantitative demonstration in a liver biopsy specimen of a concentration of copper in excess of 250 mcg/g dry weight. Treatment has two objectives. (1) to minimize dietary intake and absorption of copper. (2) to promote excretion of copper deposited in tissues. The first objective is attained by a daily diet that contains no more than one or two milligrams of copper. Such a diet should exclude, most importantly, chocolate, nuts, shellfish, mushrooms, liver, molasses, broccoli, and cereals enriched with copper, and be composed to as great an extent as possible of foods with a low copper content. Distilled or demineralized water should be used if the patient’s drinking water contains more than 0.1 mg of copper per liter. For the second objective, a copper chelating agent is used. In symptomatic patients, this treatment usually produces marked neurologic improvement, fading of Kayser-Fleischer rings, and gradual amelioration of hepatic dysfunction and psychic disturbances. Clinical experience to date suggests that life is prolonged with the above regimen. Noticeable improvement may not occur for one to three months. Occasionally, neurologic symptoms become worse during initiation of therapy with penicillamine tablets. Despite this, the drug should not be discontinued permanently. Although temporary interruption may result in clinical improvement of the neurological symptoms, it carries an increased risk of developing a sensitivity reaction upon resumption of therapy (See WARNINGS). * For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease,” F.W. Sunderman; F.W. Sunderman, Jr., (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195. Treatment of asymptomatic patients has been carried out for over ten years. Symptoms and signs of the disease appear to be prevented indefinitely if daily treatment with penicillamine tablets can be continued. Cystinuria - Cystinuria is characterized by excessive urinary excretion of the dibasic amino acids, arginine, lysine, ornithine, and cystine, and the mixed disulfide of cysteine and homocysteine. The metabolic defect that leads to cystinuria is inherited as an autosomal, recessive trait. Metabolism of the affected amino acids is influenced by at least two abnormal factors: (1) defective gastrointestinal absorption and (2) renal tubular dysfunction. Arginine, lysine, ornithine, and cysteine are soluble substances, readily excreted. There is no apparent pathology connected with their excretion in excessive quantities. Cystine, however, is so slightly soluble at the usual range of urinary pH that it is not excreted readily, and so crystallizes and forms stones in the urinary tract. Stone formation is the only known pathology in cystinuria. Normal daily output of cystine is 40 to 80 mg. In cystinuria, output is greatly increased and may exceed 1 g/day. At 500 to 600 mg/day, stone formation is almost certain. When it is more than 300 mg/day, treatment is indicated. Conventional treatment is directed at keeping urinary cystine diluted enough to prevent stone formation, keeping the urine alkaline enough to dissolve as much cystine as possible, and minimizing cystine production by a diet low in methionine (the major dietary precursor of cystine). Patients must drink enough fluid to keep urine specific gravity below 1.010, take enough alkali to keep urinary pH at 7.5 to 8, and maintain a diet low in methionine. This diet is not recommended in growing children and probably is contraindicated in pregnancy because of its low protein content (see PRECAUTIONS). When these measures are inadequate to control recurrent stone formation, penicillamine tablets may be used as additional therapy. When patients refuse to adhere to conventional treatment, penicillamine tablets may be a useful substitute. It is capable of keeping cystine excretion to near normal values, thereby hindering stone formation and the serious consequences of pyelonephritis and impaired renal function that develop in some patients. Bartter and colleagues depict the process by which penicillamine interacts with cystine to form penicillamine-cysteine mixed disulfide as. CSSC = cystine. CS' = deprotonated cysteine. PSSP = penicillamine. PS' = deprotonated penicillamine sulfhydryl. CSSP = penicillamine-cysteine mixed disulphide. In this process, it is assumed that the deprotonated form of penicillamine, PS', is the active factor in bringing about the disulfide interchange. Rheumatoid Arthritis - Because penicillamine tablets can cause severe adverse reactions, its use in rheumatoid arthritis should be restricted to patients who have severe, active disease and who have failed to respond to an adequate trial of conventional therapy. Even then, benefit-to-risk ratio should be carefully considered. Other measures, such as rest, physiotherapy, salicylates, and corticosteroids should be used, when indicated, in conjunction with penicillamine tablets (see PRECAUTIONS).",
      "Description": "Penicillamine is 3-mercapto-D-valine, a disease modifying antirheumatic drug. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:[α]25° = -62.5° ± 2.0° (C = 1, 1 NNaOH)   DThe empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine tablets, USP (Titratable Tablets) for oral administration contain 250 mg of penicillamine. Other ingredients (inactive): anhydrous lactose, copovidone, corn starch (maize), edetate disodium dihydrate, hypromellose, lactose monohydrate, magnesium stearate, magnesium trisilicate, polyethylene glycol, povidone and stearic acid."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"72936-010-88","ProprietaryName":"Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30","NonProprietaryName":"Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30"},{"NDCCode":"72936-010-75","ProprietaryName":"Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30","NonProprietaryName":"Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30"},{"NDCCode":"71977-010-03","ProprietaryName":"Daredevil Strength Muscle And Arthritis Pain Relieving Roll On","NonProprietaryName":"Menthol"},{"NDCCode":"80808-010-98","ProprietaryName":"Hygenize Alcohol Wipes","NonProprietaryName":"Alcohol"},{"NDCCode":"83254-010-88","ProprietaryName":"Nanz Povidone Iodine 10% Solution","NonProprietaryName":"Povidone Iodine 10% Solution"},{"NDCCode":"84178-010-01","ProprietaryName":"Sanar Natural-arnica Roll On","NonProprietaryName":"Evi Labs"},{"NDCCode":"16590-010-20","ProprietaryName":"Ambien","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"16590-010-28","ProprietaryName":"Ambien","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"16590-010-30","ProprietaryName":"Ambien","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"16590-010-56","ProprietaryName":"Ambien","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"43066-010-01","ProprietaryName":"Docetaxel","NonProprietaryName":"Docetaxel"},{"NDCCode":"49281-122-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-123-65","ProprietaryName":"Fluzone High-dose Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-312-50","ProprietaryName":"Fluzone Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-322-50","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-323-50","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-379-50","ProprietaryName":"Fluzone High-dose Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-418-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-420-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-421-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-422-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-423-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49281-467-65","ProprietaryName":"Fluzone High Dose Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"61315-010-01","ProprietaryName":"Arllin Golden Combination Charisma Cc","NonProprietaryName":"Titanium Dioxide, Octinoxate, Zinc Oxide"},{"NDCCode":"69894-010-01","ProprietaryName":"Co2 Carbonic Body Fit","NonProprietaryName":"Glycerin"},{"NDCCode":"83703-044-50","ProprietaryName":"Fluzone Quadrivalent Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"72936-020-04","ProprietaryName":"Higher Education Make Out Ready Moisturizing Lip Balm Spf 15","NonProprietaryName":"Higher Education Make Out Ready Moisturizing Lip Balm Spf 15"},{"NDCCode":"72936-030-60","ProprietaryName":"Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid","NonProprietaryName":"Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid"},{"NDCCode":"72936-777-15","ProprietaryName":"Spf15 Sunscreen Lip Balm","NonProprietaryName":"Avobenzone, Octinoxate, Octisalate, Octocrylene"},{"NDCCode":"0254-2000-01","ProprietaryName":"Penicillamine","NonProprietaryName":"Penicillamine"}]}
                    

<NDCList><NDC><NDCCode>72936-010-88</NDCCode><ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName><NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName></NDC><NDC><NDCCode>72936-010-75</NDCCode><ProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</ProprietaryName><NonProprietaryName>Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30</NonProprietaryName></NDC><NDC><NDCCode>71977-010-03</NDCCode><ProprietaryName>Daredevil Strength Muscle And Arthritis Pain Relieving Roll On</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>80808-010-98</NDCCode><ProprietaryName>Hygenize Alcohol Wipes</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83254-010-88</NDCCode><ProprietaryName>Nanz Povidone Iodine 10% Solution</ProprietaryName><NonProprietaryName>Povidone Iodine 10% Solution</NonProprietaryName></NDC><NDC><NDCCode>84178-010-01</NDCCode><ProprietaryName>Sanar Natural-arnica Roll On</ProprietaryName><NonProprietaryName>Evi Labs</NonProprietaryName></NDC><NDC><NDCCode>16590-010-20</NDCCode><ProprietaryName>Ambien</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>16590-010-28</NDCCode><ProprietaryName>Ambien</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>16590-010-30</NDCCode><ProprietaryName>Ambien</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>16590-010-56</NDCCode><ProprietaryName>Ambien</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>43066-010-01</NDCCode><ProprietaryName>Docetaxel</ProprietaryName><NonProprietaryName>Docetaxel</NonProprietaryName></NDC><NDC><NDCCode>49281-122-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-123-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-312-50</NDCCode><ProprietaryName>Fluzone Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-322-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-323-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-379-50</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-418-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-420-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-421-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-422-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-423-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-467-65</NDCCode><ProprietaryName>Fluzone High Dose Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>61315-010-01</NDCCode><ProprietaryName>Arllin Golden Combination Charisma Cc</ProprietaryName><NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>69894-010-01</NDCCode><ProprietaryName>Co2 Carbonic Body Fit</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>83703-044-50</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>72936-020-04</NDCCode><ProprietaryName>Higher Education Make Out Ready Moisturizing Lip Balm Spf 15</ProprietaryName><NonProprietaryName>Higher Education Make Out Ready Moisturizing Lip Balm Spf 15</NonProprietaryName></NDC><NDC><NDCCode>72936-030-60</NDCCode><ProprietaryName>Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid</ProprietaryName><NonProprietaryName>Higher Education Rush Clear Complexion Wipes With 2% Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>72936-777-15</NDCCode><ProprietaryName>Spf15 Sunscreen Lip Balm</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>0254-2000-01</NDCCode><ProprietaryName>Penicillamine</ProprietaryName><NonProprietaryName>Penicillamine</NonProprietaryName></NDC></NDCList>