RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "24488-024-26",
      "PackageDescription": "74 mL in 1 BOTTLE, WITH APPLICATOR (24488-024-26)",
      "NDC11Code": "24488-0024-26",
      "ProductNDC": "24488-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Creations Garden",
      "ProprietaryNameSuffix": "Pain Relief Roll On",
      "NonProprietaryName": "Camphor, Menthol, And Methyl Salicylate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100310",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Creations Garden Natural Products, Inc.",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
      "StrengthNumber": "2.96; 7.4; 22.2",
      "StrengthUnit": "mL/74mL; mL/74mL; mL/74mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "IndicationAndUsage": "Temporarily relieves the minor aches and  pains of muscles and joints  associated with: 1 arthritis, 2 strains, 3 bruises, 4 sprains, 5 backache."
    },
    {
      "NDCCode": "24488-024-03",
      "PackageDescription": "74 mL in 1 BOTTLE, WITH APPLICATOR (24488-024-03)",
      "NDC11Code": "24488-0024-03",
      "ProductNDC": "24488-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "True Essentials",
      "ProprietaryNameSuffix": "Pain Relief Roll On",
      "NonProprietaryName": "Camphor, Menthol, And Methyl Salicylate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100310",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Fortune Hi-Tech Marketing, Inc",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
      "StrengthNumber": "2.96; 7.4; 22.2",
      "StrengthUnit": "mL/74mL; mL/74mL; mL/74mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temporarily relieves the minor aches and  pains of muscles and joints  associated with: 1 arthritis, 2 strains, 3 bruises, 4 sprains, 5 backache."
    },
    {
      "NDCCode": "13537-024-26",
      "PackageDescription": "1 TUBE in 1 BOX (13537-024-26)  > 4 g in 1 TUBE (13537-024-25)",
      "NDC11Code": "13537-0024-26",
      "ProductNDC": "13537-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Hd Color High Definition Color Spf 20",
      "ProprietaryNameSuffix": "(hd Ciruela Glam) - Red",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140403",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": ".068",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "42388-024-26",
      "PackageDescription": "30 TABLET in 1 BOTTLE (42388-024-26) ",
      "NDC11Code": "42388-0024-26",
      "ProductNDC": "42388-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cabometyx",
      "NonProprietaryName": "Cabozantinib",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160425",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208692",
      "LabelerName": "Exelixis, Inc.",
      "SubstanceName": "CABOZANTINIB S-MALATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160425",
      "SamplePackage": "N",
      "IndicationAndUsage": "CABOMETYX is a kinase inhibitor indicated for the treatment of: 1 patients with advanced renal cell carcinoma (RCC). (1.1), 2 patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab (1.1), 3 patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.2), 4 adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible (1.3), 5 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). (1.4), 6 adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). (1.4).",
      "Description": "CABOMETYX is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)-malate is described chemically as N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5C4H6O5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib (S)-malate salt is. Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media. CABOMETYX (cabozantinib) tablets for oral use are supplied as film-coated tablets containing 20 mg, 40 mg, or 60 mg of cabozantinib, which is equivalent to 25 mg, 51 mg, or 76 mg of cabozantinib (S)-malate, respectively. CABOMETYX also contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow."
    },
    {
      "NDCCode": "49738-024-26",
      "PackageDescription": "80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49738-024-26) ",
      "NDC11Code": "49738-0024-26",
      "ProductNDC": "49738-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Extra Strength Pain Relief",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Kmart Corporation",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:. the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever."
    },
    {
      "NDCCode": "59779-024-26",
      "PackageDescription": "226 g in 1 BOTTLE, PLASTIC (59779-024-26)",
      "NDC11Code": "59779-0024-26",
      "ProductNDC": "59779-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Pharmacy Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121219",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "2; 10; 5; 2; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in water."
    },
    {
      "NDCCode": "67544-024-26",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (67544-024-26)",
      "NDC11Code": "67544-0024-26",
      "ProductNDC": "67544-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040201",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "68405-024-26",
      "PackageDescription": "1 KIT in 1 KIT (68405-024-26)  *  30 TABLET in 1 BOTTLE (52959-321-30)  *  60 CAPSULE in 1 BOTTLE",
      "NDC11Code": "68405-0024-26",
      "ProductNDC": "68405-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabazolamine",
      "NonProprietaryName": "Alprazolam, Choline",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20110707",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Physician Therapeutics LLC",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "73069-024-26",
      "PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-024-26)  > 2 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0024-26",
      "ProductNDC": "73069-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-adipose",
      "NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
      "StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0093-3186-20",
      "PackageDescription": "1 TUBE in 1 CARTON (0093-3186-20)  > 5 g in 1 TUBE",
      "NDC11Code": "00093-3186-20",
      "ProductNDC": "0093-3186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penciclovir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212710",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2022-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Penciclovir cream 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
      "Description": "Penciclovir cream 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir cream is available for topical administration as a 1% white cream. Each gram of penciclovir cream contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Figure 1: Structural Formula of Penciclovir. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
    },
    {
      "NDCCode": "0378-0896-55",
      "PackageDescription": "1 TUBE in 1 CARTON (0378-0896-55)  / 5 g in 1 TUBE",
      "NDC11Code": "00378-0896-55",
      "ProductNDC": "0378-0896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penciclovir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221116",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020629",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
      "Description": "Penciclovir cream 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir cream is available for topical administration as a 1% white cream. Each gram of penciclovir cream contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
    },
    {
      "NDCCode": "0378-9720-55",
      "PackageDescription": "1 TUBE in 1 CARTON (0378-9720-55)  / 5 g in 1 TUBE",
      "NDC11Code": "00378-9720-55",
      "ProductNDC": "0378-9720",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Denavir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180924",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020629",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180924",
      "SamplePackage": "N",
      "IndicationAndUsage": "DENAVIR is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
      "Description": "DENAVIR (penciclovir) cream 1% contains penciclovir, an antiviral agent active against herpes viruses. DENAVIR is available for topical administration as a 1% white cream. Each gram of DENAVIR contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
    },
    {
      "NDCCode": "13537-606-26",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-606-26)  > 30 g in 1 BOTTLE (13537-606-25)",
      "NDC11Code": "13537-0606-26",
      "ProductNDC": "13537-606",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(medium 7) - Brown",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13668-661-10",
      "PackageDescription": "1 TUBE in 1 CARTON (13668-661-10)  / 5 g in 1 TUBE",
      "NDC11Code": "13668-0661-10",
      "ProductNDC": "13668-661",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penciclovir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216981",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
      "Description": "Penciclovir cream contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir cream is available for topical administration as a 1% white cream. Each gram of penciclovir cream contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Figure 1: Structural Formula of Penciclovir. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
    },
    {
      "NDCCode": "14783-606-26",
      "PackageDescription": "1 BOTTLE in 1 BOX (14783-606-26)  > 30 g in 1 BOTTLE (14783-606-25)",
      "NDC11Code": "14783-0606-26",
      "ProductNDC": "14783-606",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
      "ProprietaryNameSuffix": "(medium 7) - Brown",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": ".065; .024; .015",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "21922-024-11",
      "PackageDescription": "430 g in 1 JAR (21922-024-11) ",
      "NDC11Code": "21922-0024-11",
      "ProductNDC": "21922-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide Ointment Usp, 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212384",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone Acetonide Ointment 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Graphic Formula:. C24H31FO6, MW 434.50 Each gram of 0.05% Triamcinolone Acetonide Ointment USP provides 0.5 mg of Triamcinolone Acetonide in a water­ in-oil emulsion composed of light mineral oil, purified water, white petrolatum, mineral oil, ceresin wax 155/165, and lanolin alcohols."
    },
    {
      "NDCCode": "33332-024-03",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-024-03)  / .5 mL in 1 SYRINGE, GLASS (33332-024-04) ",
      "NDC11Code": "33332-0024-03",
      "ProductNDC": "33332-024",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Afluria",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/thailand/8/2022 Ivr-237 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240701",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125254",
      "LabelerName": "Seqirus PTY LTD.",
      "SubstanceName": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240701",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "AFLURIA® is an inactivated influenza vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. AFLURIA is approved for use in persons 6 months of age and older.",
      "Description": "AFLURIA, Influenza Vaccine, is a sterile, clear, colorless to slightly opalescent injectable suspension for intramuscular use with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza viruses propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the viruses are purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified viruses are inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce “split virions”. The disrupted viruses are further purified and suspended in a phosphate buffered isotonic solution. AFLURIA is standardized according to USPHS requirements for the 2024-2025 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2024-2025 Northern Hemisphere influenza season:. A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus); A/Thailand/8/2022 IVR-237 (an A/Thailand/8/2022 (H3N2)-like virus); and B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus). A 0.25 mL dose contains 7.5 mcg HA of each of the same influenza strains. Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain preservative. The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury. A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 61.5 nanograms [ng]), polymyxin B (≤ 10.5 ng), beta-propiolactone (< 2.3 ng) and hydrocortisone (≤ 0.56 ng). A single 0.25 mL dose of AFLURIA contains half of these quantities. The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial are not made with natural rubber latex."
    },
    {
      "NDCCode": "45802-440-75",
      "PackageDescription": "1 TUBE in 1 CARTON (45802-440-75)  / 5 g in 1 TUBE",
      "NDC11Code": "45802-0440-75",
      "ProductNDC": "45802-440",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penciclovir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241107",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212368",
      "LabelerName": "Padagis Israel Pharmaceuticals Ltd",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2024-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
      "Description": "Penciclovir Cream, 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir Cream, 1% is available for topical administration as a 1% white cream. Each gram of Penciclovir Cream, 1% contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Figure 1: Structural Formula of Penciclovir. penciclovir. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
    },
    {
      "NDCCode": "49629-024-99",
      "PackageDescription": "27878 TABLET in 1 DRUM (49629-024-99) ",
      "NDC11Code": "49629-0024-99",
      "ProductNDC": "49629-024",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20180207",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Rottendorf Pharma GmbH",
      "SubstanceName": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
      "StrengthNumber": "50; 200; 25",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-04-17",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "15-APR-26"
    },
    {
      "NDCCode": "51224-024-50",
      "PackageDescription": "100 TABLET in 1 BOTTLE (51224-024-50) ",
      "NDC11Code": "51224-0024-50",
      "ProductNDC": "51224-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methazolamide",
      "NonProprietaryName": "Methazolamide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215615",
      "LabelerName": "TAGI Pharma, Inc.",
      "SubstanceName": "METHAZOLAMIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methazolamide Tablets, USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.",
      "Description": "Methazolamide, a sulfonamide derivative, is a white or faintly yellow, crystalline powder, soluble in dimethyl formamide, slightly soluble in acetone, very slightly soluble in water and alcohol. The chemical name for methazolamide is. Acetamide, N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]- and it has the following structural formula. C5H8N4O3S2236.26. Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and isopropyl alcohol. Isopropyl alcohol is removed during manufacturing process."
    },
    {
      "NDCCode": "54868-4956-0",
      "PackageDescription": "1 TUBE in 1 CARTON (54868-4956-0)  > 1.5 g in 1 TUBE",
      "NDC11Code": "54868-4956-00",
      "ProductNDC": "54868-4956",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Denavir",
      "NonProprietaryName": "Penciclovir",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20031113",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020629",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "PENCICLOVIR",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.",
      "Description": "Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl) butyl]guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62)."
    },
    {
      "NDCCode": "63189-024-20",
      "PackageDescription": "1 BAG in 1 DRUM (63189-024-20)  / 121212 TABLET in 1 BAG",
      "NDC11Code": "63189-0024-20",
      "ProductNDC": "63189-024",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "AMOL PHARMACEUTICALS PRIVATE LIMITED",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "8.6",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-01",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-26"
    },
    {
      "NDCCode": "66019-112-10",
      "PackageDescription": "10 APPLICATOR in 1 CARTON (66019-112-10)  / .2 mL in 1 APPLICATOR (66019-112-00) ",
      "NDC11Code": "66019-0112-10",
      "ProductNDC": "66019-112",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250801",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/PERTH/722/2024 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250801",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Each of the reassortant strains in FluMist express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2025-2026 influenza season. The viruses (A/H1N1, A/H3N2 and the B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent influenza vaccine formulation. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Norway/31694/2022 (H1N1) (an A/Victoria/4897/2022 (H1N1)pdm09 - like virus), A/Perth/722/2024 (H3N2) (an A/Croatia/10136RV/2023 (H3N2) - like virus), and B/Austria/1359417/2021 (B/Victoria lineage) (a B/Austria/1359417/2021 (B/Victoria lineage) - like virus). Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "66019-112-51",
      "PackageDescription": "1 APPLICATOR in 1 CARTON (66019-112-51)  / .2 mL in 1 APPLICATOR (66019-112-00) ",
      "NDC11Code": "66019-0112-51",
      "ProductNDC": "66019-112",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250801",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/PERTH/722/2024 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250801",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Each of the reassortant strains in FluMist express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2025-2026 influenza season. The viruses (A/H1N1, A/H3N2 and the B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent influenza vaccine formulation. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Norway/31694/2022 (H1N1) (an A/Victoria/4897/2022 (H1N1)pdm09 - like virus), A/Perth/722/2024 (H3N2) (an A/Croatia/10136RV/2023 (H3N2) - like virus), and B/Austria/1359417/2021 (B/Victoria lineage) (a B/Austria/1359417/2021 (B/Victoria lineage) - like virus). Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "66019-113-10",
      "PackageDescription": "10 APPLICATOR in 1 CARTON (66019-113-10)  / .2 mL in 1 APPLICATOR (66019-113-00) ",
      "NDC11Code": "66019-0113-10",
      "ProductNDC": "66019-113",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260722",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260722",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses expected to circulate during the 2026-2027 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Switzerland/6849/2025 (H1N1) (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Darwin/1369/2025 (H3N2) (an A/Darwin/1454/2025 (H3N2)-like virus), and B/Perth/115/2025 (B/Victoria lineage) (a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "66019-113-51",
      "PackageDescription": "1 APPLICATOR in 1 CARTON (66019-113-51)  / .2 mL in 1 APPLICATOR (66019-113-00) ",
      "NDC11Code": "66019-0113-51",
      "ProductNDC": "66019-113",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20260722",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260722",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses expected to circulate during the 2026-2027 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Switzerland/6849/2025 (H1N1) (an A/Missouri/11/2025 (H1N1)pdm09-like virus), A/Darwin/1369/2025 (H3N2) (an A/Darwin/1454/2025 (H3N2)-like virus), and B/Perth/115/2025 (B/Victoria lineage) (a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus). These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "66019-310-10",
      "PackageDescription": "10 APPLICATOR in 1 PACKAGE (66019-310-10)  / .2 mL in 1 APPLICATOR (66019-310-01) ",
      "NDC11Code": "66019-0310-10",
      "ProductNDC": "66019-310",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist Quadrivalent",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20230814",
      "EndMarketingDate": "20250303",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/NORWAY/16606/2021 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230814",
      "EndMarketingDatePackage": "20250303",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist® 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 [see Description (11)]. FluMist Quadrivalent is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is a live quadrivalent vaccine for administration by intranasal spray. FluMist Quadrivalent contains four vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and two B strains. FluMist Quadrivalent contains B strains from both the B/Yamagata/16/88 and the B/Victoria/2/87 lineages. FluMist Quadrivalent is manufactured according to the same process as FluMist. The influenza virus strains in FluMist Quadrivalent are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strains) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the four reassortant strains in FluMist Quadrivalent, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the four viruses contained in FluMist Quadrivalent maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Each of the reassortant strains in FluMist Quadrivalent express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2023-2024 influenza season. Three of the viruses (A/H1N1, A/H3N2 and one B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent and quadrivalent influenza vaccine formulations. An additional B strain has been recommended by the USPHS for inclusion in the quadrivalent influenza vaccine formulation. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the four strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the quadrivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist Quadrivalent sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5‑7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the four strains: A/Norway/31694/2022 (H1N1) (an A/Victoria/4897/2022 (H1N1)pdm09 - like virus), A/Norway/16606/2021 (H3N2) (an A/Darwin/9/2021 (H3N2) - like virus), B/Phuket/3073/2013 (B/Yamagata lineage), and B/Austria/1359417/2021 (B/Victoria lineage). Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist Quadrivalent contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist Quadrivalent is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "66019-311-10",
      "PackageDescription": "10 APPLICATOR in 1 PACKAGE (66019-311-10)  / .2 mL in 1 APPLICATOR (66019-311-00) ",
      "NDC11Code": "66019-0311-10",
      "ProductNDC": "66019-311",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flumist",
      "NonProprietaryName": "Influenza Vaccine Live Intranasal",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20240806",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125020",
      "LabelerName": "MedImmune, LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/THAILAND/8/2022 (H3N2) LIVE; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN",
      "StrengthNumber": "10000000; 10000000; 10000000",
      "StrengthUnit": "[FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240806",
      "SamplePackage": "N",
      "IndicationAndUsage": "FluMist® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11)]. FluMist is approved for use in persons 2 through 49 years of age.",
      "Description": "FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection). No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see Clinical Pharmacology (12.2)]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property. Each of the reassortant strains in FluMist express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2024-2025 influenza season. The viruses (A/H1N1, A/H3N2 and the B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent influenza vaccine formulation. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Norway/31694/2022 (H1N1) (an A/Victoria/4897/2022 (H1N1)pdm09 - like virus), A/Thailand/8/2022 (H3N2) (an A/Thailand/8/2022 (H3N2) – like virus), and B/Austria/1359417/2021 (B/Victoria lineage) (a B/Austria/1359417/2021 (B/Victoria lineage) – like virus). Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy."
    },
    {
      "NDCCode": "69962-024-30",
      "PackageDescription": "30 g in 1 JAR (69962-024-30)",
      "NDC11Code": "69962-0024-30",
      "ProductNDC": "69962-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fidelis Topical Anesthetic",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "GEL",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Webco Dental & Medical Supplies, Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "70461-024-03",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (70461-024-03)  / .5 mL in 1 SYRINGE, GLASS (70461-024-04) ",
      "NDC11Code": "70461-0024-03",
      "ProductNDC": "70461-024",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluad",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/thailand/8/2022 Ivr-237 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240701",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125510",
      "LabelerName": "Seqirus, Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240701",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
      "Description": "FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus. FLUAD is standardized according to United States Public Health Service requirements and each 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following influenza strains recommended for the 2024-2025 influenza season: A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Thailand/8/2022 IVR-237 (an A/Thailand/8/2022 (H3N2)-like virus), B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus). FLUAD also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. Each of the strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). The antigen preparation is further purified. FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant. After combining, FLUAD is a sterile, milky-white injectable emulsion supplied in single-dose pre-filled syringes containing 0.5 mL dose. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7. FLUAD may contain trace amounts of neomycin (≤ 0.02 mcg by calculation), kanamycin (≤ 0.03 mcg by calculation) and hydrocortisone (≤ 0.005 ng by calculation) which are used during the initial stages of manufacture, as well as residual egg protein (ovalbumin) (≤ 0.4 mcg), formaldehyde (≤ 10 mcg) or CTAB (≤ 12 mcg). FLUAD does not contain a preservative. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex."
    }
  ]
}
                    

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