{
"NDC": [
{
"NDCCode": "0078-0518-16",
"PackageDescription": ".025 L in 1 BOTTLE, DROPPER (0078-0518-16)",
"NDC11Code": "00078-0518-16",
"ProductNDC": "0078-0518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal",
"ProprietaryNameSuffix": "Mild To Moderate",
"NonProprietaryName": "Hypromellose",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Novartis Pharmaceutical Corporation",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": ".003",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0078-0518-24",
"PackageDescription": ".015 L in 1 BOTTLE, DROPPER (0078-0518-24)",
"NDC11Code": "00078-0518-24",
"ProductNDC": "0078-0518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal",
"ProprietaryNameSuffix": "Mild To Moderate",
"NonProprietaryName": "Hypromellose",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Novartis Pharmaceutical Corporation",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": ".003",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "63824-518-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (63824-518-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "63824-0518-16",
"ProductNDC": "63824-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Mucinex Fast-max Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180728",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180728",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: nasal congestionheadachecoughminor aches and painssore throatsinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "0078-0425-16",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0078-0425-16) > 25 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00078-0425-16",
"ProductNDC": "0078-0425",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal",
"ProprietaryNameSuffix": "Moderate To Severe",
"NonProprietaryName": "Hypromelloses And Carboxymethylcellulose Sodium",
"DosageFormName": "GEL",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Novartis Pharmaceutical Corporation",
"SubstanceName": "HYPROMELLOSES; CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "3; 2.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0078-0517-16",
"PackageDescription": ".025 L in 1 BOTTLE, DROPPER (0078-0517-16) ",
"NDC11Code": "00078-0517-16",
"ProductNDC": "0078-0517",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal",
"ProprietaryNameSuffix": "Mild",
"NonProprietaryName": "Hypromellose",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Novartis Pharmaceutical Corporation",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": "200",
"StrengthUnit": "mg/L",
"Status": "Deprecated",
"LastUpdate": "2020-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090914",
"SamplePackage": "N"
},
{
"NDCCode": "0869-0078-16",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (0869-0078-16) ",
"NDC11Code": "00869-0078-16",
"ProductNDC": "0869-0078",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Castor Oil",
"NonProprietaryName": "Castor Oil",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19890715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "CASTOR OIL",
"StrengthNumber": "1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19890715",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "16729-078-16",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-16)",
"NDC11Code": "16729-0078-16",
"ProductNDC": "16729-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202323",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55312-078-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (55312-078-16) ",
"NDC11Code": "55312-0078-16",
"ProductNDC": "55312-078",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"ProprietaryNameSuffix": "91 Percent",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Western Family Foods, Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "91",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141031",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "68382-078-16",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-078-16) ",
"NDC11Code": "68382-0078-16",
"ProductNDC": "68382-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081215",
"EndMarketingDate": "20190316",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022224",
"LabelerName": "Zydus Pharmaceuticals USA Inc",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081215",
"EndMarketingDatePackage": "20190316",
"SamplePackage": "N"
},
{
"NDCCode": "11673-518-24",
"PackageDescription": "1 KIT in 1 KIT (11673-518-24) * 8 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "11673-0518-24",
"ProductNDC": "11673-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Mucus Relief Severe Cold Nighttime Cold And Flu",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin",
"DosageFormName": "KIT",
"StartMarketingDate": "20180531",
"EndMarketingDate": "20250530",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TARGET Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180531",
"EndMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "DAYTIME: 1 temporarily relieves these common cold and flu symptomsheadachenasal congestionsore throatcoughminor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever."
},
{
"NDCCode": "21130-518-24",
"PackageDescription": "1 KIT in 1 CARTON (21130-518-24) * 8 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "21130-0518-24",
"ProductNDC": "21130-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin",
"DosageFormName": "KIT",
"StartMarketingDate": "20180331",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Safeway, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180331",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "DAYTIME: 1 temporarily relieves these common cold and flu symptomsheadachenasal congestionsore throatcoughminor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever."
},
{
"NDCCode": "43742-0518-1",
"PackageDescription": "960 mL in 1 BOTTLE (43742-0518-1) ",
"NDC11Code": "43742-0518-01",
"ProductNDC": "43742-0518",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cytomegalovirus Nosode",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140930",
"EndMarketingDate": "20241219",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HUMAN HERPESVIRUS 5",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "05-APR-16",
"EndMarketingDatePackage": "19-DEC-24"
},
{
"NDCCode": "43857-0518-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0518-1) ",
"NDC11Code": "43857-0518-01",
"ProductNDC": "43857-0518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neurotox",
"NonProprietaryName": "Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190905",
"EndMarketingDate": "20241120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190905",
"EndMarketingDatePackage": "20241120",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain."
},
{
"NDCCode": "49035-518-18",
"PackageDescription": "70 g in 1 JAR (49035-518-18) ",
"NDC11Code": "49035-0518-18",
"ProductNDC": "49035-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "White Petrolatum",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to diaper rash. helps seal out wetness."
},
{
"NDCCode": "49035-518-96",
"PackageDescription": "212 g in 1 JAR (49035-518-96) ",
"NDC11Code": "49035-0518-96",
"ProductNDC": "49035-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "White Petrolatum",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to diaper rash. helps seal out wetness."
},
{
"NDCCode": "49281-518-25",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-518-25) > .25 mL in 1 SYRINGE, GLASS (49281-518-00) ",
"NDC11Code": "49281-0518-25",
"ProductNDC": "49281-518",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Quadrivalent",
"NonProprietaryName": "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/phuket/3073/2013 Antigen (formaldehyde Inactivated), And 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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
"Status": "Deprecated",
"LastUpdate": "2019-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N"
},
{
"NDCCode": "61269-518-12",
"PackageDescription": "1 INHALER in 1 CARTON (61269-518-12) / 120 AEROSOL, POWDER in 1 INHALER",
"NDC11Code": "61269-0518-12",
"ProductNDC": "61269-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pulmicort",
"ProprietaryNameSuffix": "Flexhaler",
"NonProprietaryName": "Budesonide",
"DosageFormName": "AEROSOL, POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021949",
"LabelerName": "H2-Pharma LLC",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "180",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070319",
"SamplePackage": "N",
"IndicationAndUsage": "PULMICORT FLEXHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older (1) .",
"Description": "Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. PULMICORT FLEXHALER is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see Contraindications (4), Adverse Reactions (6.2)]. Each actuation of PULMICORT FLEXHALER 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER 180 mcg contains 120 actuations and each PULMICORT FLEXHALER 90 mcg contains 60 actuations. In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40-50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see Patient Information and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV1 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery."
},
{
"NDCCode": "72789-518-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01) ",
"NDC11Code": "72789-0518-01",
"ProductNDC": "72789-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218912",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72789-518-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15) ",
"NDC11Code": "72789-0518-15",
"ProductNDC": "72789-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218912",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72789-518-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90) ",
"NDC11Code": "72789-0518-90",
"ProductNDC": "72789-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218912",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0078-0179-05",
"PackageDescription": "100 TABLET in 1 BOTTLE (0078-0179-05) ",
"NDC11Code": "00078-0179-05",
"ProductNDC": "0078-0179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamisil",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020539",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine [CS],Allylamine Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19960510",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0179-15",
"PackageDescription": "30 TABLET in 1 BOTTLE (0078-0179-15) ",
"NDC11Code": "00078-0179-15",
"ProductNDC": "0078-0179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamisil",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020539",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine [CS],Allylamine Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19960510",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0314-34",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34) ",
"NDC11Code": "00078-0314-34",
"ProductNDC": "0078-0314",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980306",
"SamplePackage": "N",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "0078-0315-34",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34) ",
"NDC11Code": "00078-0315-34",
"ProductNDC": "0078-0315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "160; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980306",
"SamplePackage": "N",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "0078-0343-45",
"PackageDescription": "3 BOX in 1 CARTON (0078-0343-45) > 8 POUCH in 1 BOX (0078-0343-42) > 1 PATCH in 1 POUCH (0078-0343-62) > 3.5 d in 1 PATCH",
"NDC11Code": "00078-0343-45",
"ProductNDC": "0078-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivelle-dot",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "19990108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020538",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-16",
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"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
}
]
}
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<NDCCode>21130-518-24</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21130-518-24) * 8 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0518-24</NDC11Code>
<ProductNDC>21130-518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,guaifenesin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180331</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<EndMarketingDatePackage>20250331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYTIME: 1 temporarily relieves these common cold and flu symptomsheadachenasal congestionsore throatcoughminor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43742-0518-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE (43742-0518-1) </PackageDescription>
<NDC11Code>43742-0518-01</NDC11Code>
<ProductNDC>43742-0518</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cytomegalovirus Nosode</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140930</StartMarketingDate>
<EndMarketingDate>20241219</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>HUMAN HERPESVIRUS 5</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>05-APR-16</StartMarketingDatePackage>
<EndMarketingDatePackage>19-DEC-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43857-0518-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0518-1) </PackageDescription>
<NDC11Code>43857-0518-01</NDC11Code>
<ProductNDC>43857-0518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neurotox</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190905</StartMarketingDate>
<EndMarketingDate>20241120</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190905</StartMarketingDatePackage>
<EndMarketingDatePackage>20241120</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-518-18</NDCCode>
<PackageDescription>70 g in 1 JAR (49035-518-18) </PackageDescription>
<NDC11Code>49035-0518-18</NDC11Code>
<ProductNDC>49035-518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>White Petrolatum</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to diaper rash. helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-518-96</NDCCode>
<PackageDescription>212 g in 1 JAR (49035-518-96) </PackageDescription>
<NDC11Code>49035-0518-96</NDC11Code>
<ProductNDC>49035-518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>White Petrolatum</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to diaper rash. helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49281-518-25</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-518-25) > .25 mL in 1 SYRINGE, GLASS (49281-518-00) </PackageDescription>
<NDC11Code>49281-0518-25</NDC11Code>
<ProductNDC>49281-518</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
<NonProprietaryName>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/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61269-518-12</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (61269-518-12) / 120 AEROSOL, POWDER in 1 INHALER</PackageDescription>
<NDC11Code>61269-0518-12</NDC11Code>
<ProductNDC>61269-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pulmicort</ProprietaryName>
<ProprietaryNameSuffix>Flexhaler</ProprietaryNameSuffix>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>AEROSOL, POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021949</ApplicationNumber>
<LabelerName>H2-Pharma LLC</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PULMICORT FLEXHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older (1) .</IndicationAndUsage>
<Description>Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. PULMICORT FLEXHALER is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see Contraindications (4), Adverse Reactions (6.2)]. Each actuation of PULMICORT FLEXHALER 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER 180 mcg contains 120 actuations and each PULMICORT FLEXHALER 90 mcg contains 60 actuations. In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40-50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see Patient Information and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV1 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery.</Description>
</NDC>
<NDC>
<NDCCode>72789-518-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01) </PackageDescription>
<NDC11Code>72789-0518-01</NDC11Code>
<ProductNDC>72789-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218912</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72789-518-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15) </PackageDescription>
<NDC11Code>72789-0518-15</NDC11Code>
<ProductNDC>72789-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218912</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72789-518-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90) </PackageDescription>
<NDC11Code>72789-0518-90</NDC11Code>
<ProductNDC>72789-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218912</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H-phenothiazine ( Z)-2-butenedioate (1:2) and has the following structure:. Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Diovan HCT may be substituted for the titrated components. Initial Therapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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