{
"NDC": [
{
"NDCCode": "50580-397-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-397-40) > 40 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0397-40",
"ProductNDC": "50580-397",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imodium",
"ProprietaryNameSuffix": "A-d",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20070201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020448",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "10812-397-90",
"PackageDescription": "1 KIT in 1 CARTON (10812-397-90) * 50 mL in 1 TUBE * 40 mL in 1 TUBE * 150 mL in 1 TUBE",
"NDC11Code": "10812-0397-90",
"ProductNDC": "10812-397",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Complete Acne Therapy System",
"NonProprietaryName": "Salicylic Acid, Octinoxate, Zinc Oxide, And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20120523",
"EndMarketingDate": "20160315",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Neutrogena Corporation",
"Status": "Deprecated",
"LastUpdate": "2016-03-18"
},
{
"NDCCode": "63833-387-02",
"PackageDescription": "1 KIT in 1 CARTON (63833-387-02) * 40 mL in 1 VIAL, SINGLE-USE (63833-397-01) * 40 mL in 1 VIAL, SINGLE-USE (63833-761-40) ",
"NDC11Code": "63833-0387-02",
"ProductNDC": "63833-387",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kcentra",
"NonProprietaryName": "Prothrombin, Coagulation Factor Vii Human, Coagulation Factor Ix Human, Coagulation Factor X Human, Protein C, Protein S Human, And Water",
"DosageFormName": "KIT",
"StartMarketingDate": "20131213",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125421",
"LabelerName": "CSL Behring GmbH",
"Status": "Active",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131213",
"SamplePackage": "N",
"IndicationAndUsage": "KCENTRA, (Prothrombin Complex Concentrate (Human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: 1 acute major bleeding or, 2 need for an urgent surgery/invasive procedure.",
"Description": "KCENTRA is a purified, heat-treated, nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate (Human) prepared from human U.S. Source Plasma (21 CFR 640.60). It contains the Vitamin K dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S. Factor IX is the lead factor for the potency of the preparation as stated on the vial label. The excipients are human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate. KCENTRA is sterile, pyrogen-free, and does not contain preservatives. The product contents are shown in Table 6 and listed as ranges for the blood coagulation factors. All plasma used in the manufacture of KCENTRA is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV, and HBV, and found to be non-reactive (negative), and the plasma is also tested by NAT for human parvovirus B19 (B19V) in order to exclude donations with high titers. The limit for B19V in the fractionation pool is set not to exceed 104 units of B19V DNA per mL. Only plasma that passed virus screening is used for production. The KCENTRA manufacturing process includes various steps, which contribute towards the reduction/inactivation of viruses. KCENTRA is manufactured from cryo-depleted plasma that is adsorbed via ion exchange chromatography, heat treated in aqueous solution for 10 hours at 60°C, precipitated, adsorbed to calcium phosphate, virus filtered, and lyophilized. Manufacturing steps were independently validated in a series of in vitro experiments for their virus inactivation / reduction capacity for both enveloped and non-enveloped viruses. Table 7 shows the virus clearance during the manufacturing process for KCENTRA, expressed as the mean log10 reduction factor."
},
{
"NDCCode": "50580-397-20",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-397-20) > 20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0397-20",
"ProductNDC": "50580-397",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imodium",
"ProprietaryNameSuffix": "A-d",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20070201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020448",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "50580-397-25",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-397-25) > 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0397-25",
"ProductNDC": "50580-397",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imodium",
"ProprietaryNameSuffix": "A-d",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20070201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020448",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "50580-397-41",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-397-41) > 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0397-41",
"ProductNDC": "50580-397",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imodium",
"ProprietaryNameSuffix": "A-d",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20070201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020448",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "50580-176-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-176-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0176-40",
"ProductNDC": "50580-176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div. McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "50580-244-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-244-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0244-40",
"ProductNDC": "50580-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-12"
},
{
"NDCCode": "50580-469-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-469-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "50580-0469-40",
"ProductNDC": "50580-469",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:."
},
{
"NDCCode": "50580-482-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-482-40) > 40 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50580-0482-40",
"ProductNDC": "50580-482",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19910424",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part338",
"LabelerName": "McNeil Consumer Healthcare Div McNeil-PPC, Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "50580-563-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50580-563-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0563-40",
"ProductNDC": "50580-563",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin",
"ProprietaryNameSuffix": "Pm",
"NonProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079113",
"LabelerName": "Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division",
"SubstanceName": "IBUPROFEN; DIPHENHYDRAMINE CITRATE",
"StrengthNumber": "200; 38",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50580-726-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50580-0726-40",
"ProductNDC": "50580-726",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019835",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140120",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "50580-726-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50580-0726-72",
"ProductNDC": "50580-726",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019835",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "50580-779-40",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (50580-779-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "50580-0779-40",
"ProductNDC": "50580-779",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20100208",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022429",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100208",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "50580-786-40",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "50580-0786-40",
"ProductNDC": "50580-786",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213105",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "50580-786-41",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "50580-0786-41",
"ProductNDC": "50580-786",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213105",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "0132-0194-14",
"PackageDescription": "397 g in 1 JAR (0132-0194-14) ",
"NDC11Code": "00132-0194-14",
"ProductNDC": "0132-0194",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boudreauxs",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "40",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "0132-0323-14",
"PackageDescription": "397 g in 1 JAR (0132-0323-14) ",
"NDC11Code": "00132-0323-14",
"ProductNDC": "0132-0323",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boudreauxs",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "40",
"StrengthUnit": "g/113g",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120201",
"SamplePackage": "N",
"IndicationAndUsage": "Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "0722-6094-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0722-6094-01) ",
"NDC11Code": "00722-6094-01",
"ProductNDC": "0722-6094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ascomp With Codeine",
"NonProprietaryName": "Butalbital, Aspirin, Cafeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075231",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20011130",
"SamplePackage": "N",
"IndicationAndUsage": "ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "ASCOMP with CODEINE (butalbital, aspirin, caffeine, and codeine phosphate, USP) is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:. Butalbital, USP……………..50mg. Aspirin, USP………………..325mg. Caffeine, USP………………40mg. Codeine phosphate, USP…...30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has a molecular formula of: C11H16N2O3, with a molecular weight of 224.26, and the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has a molecular formula of C9H8O4 with a molecular weight of 180.6, and the following structural formula:. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has a molecular formula of C8H10N4O2 with a molecular weight of 194.19, and the following structural formula:. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has a molecular formula of C18H24NO7P with an anhydrous molecular weight of 397.37, and the following structural formula:. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink."
},
{
"NDCCode": "0722-6094-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0722-6094-05) ",
"NDC11Code": "00722-6094-05",
"ProductNDC": "0722-6094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ascomp With Codeine",
"NonProprietaryName": "Butalbital, Aspirin, Cafeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075231",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20011130",
"SamplePackage": "N",
"IndicationAndUsage": "ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "ASCOMP with CODEINE (butalbital, aspirin, caffeine, and codeine phosphate, USP) is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:. Butalbital, USP……………..50mg. Aspirin, USP………………..325mg. Caffeine, USP………………40mg. Codeine phosphate, USP…...30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has a molecular formula of: C11H16N2O3, with a molecular weight of 224.26, and the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has a molecular formula of C9H8O4 with a molecular weight of 180.6, and the following structural formula:. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has a molecular formula of C8H10N4O2 with a molecular weight of 194.19, and the following structural formula:. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has a molecular formula of C18H24NO7P with an anhydrous molecular weight of 397.37, and the following structural formula:. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink."
},
{
"NDCCode": "13668-397-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-397-05) ",
"NDC11Code": "13668-0397-05",
"ProductNDC": "13668-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 20",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161026",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-397-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-397-30) ",
"NDC11Code": "13668-0397-30",
"ProductNDC": "13668-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 20",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161026",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-397-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (13668-397-90) ",
"NDC11Code": "13668-0397-90",
"ProductNDC": "13668-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 20",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161026",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "47335-046-40",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (47335-046-40) > 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "47335-0046-40",
"ProductNDC": "47335-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202922",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for.",
"Description": "Oxaliplatin injection is an antineoplastic agent with the molecular formula C8H14N2O4Ptand the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP is for intravenous use. Each mL of oxaliplatin injection contains 5 mg of oxaliplatin, USP. It is supplied as a sterile, preservative-free, aqueous solution in 50 mg/10 mL and 100 mg/20 mL vials. Water for injection is present as an inactive ingredient."
},
{
"NDCCode": "47335-047-40",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (47335-047-40) > 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "47335-0047-40",
"ProductNDC": "47335-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202922",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for.",
"Description": "Oxaliplatin injection is an antineoplastic agent with the molecular formula C8H14N2O4Ptand the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP is for intravenous use. Each mL of oxaliplatin injection contains 5 mg of oxaliplatin, USP. It is supplied as a sterile, preservative-free, aqueous solution in 50 mg/10 mL and 100 mg/20 mL vials. Water for injection is present as an inactive ingredient."
},
{
"NDCCode": "47335-176-40",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (47335-176-40) > 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "47335-0176-40",
"ProductNDC": "47335-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078818",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090819",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer.",
"Description": "Oxaliplatin for injection USP is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin for injection USP is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively."
},
{
"NDCCode": "47335-178-40",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (47335-178-40) > 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "47335-0178-40",
"ProductNDC": "47335-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078818",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090819",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer.",
"Description": "Oxaliplatin for injection USP is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin for injection USP is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively."
},
{
"NDCCode": "47781-397-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-397-60) ",
"NDC11Code": "47781-0397-60",
"ProductNDC": "47781-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate",
"NonProprietaryName": "Hydrocodone Bitartrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208269",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210303",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Hydrocodone bitartrate extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist. Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is. Empirical formula: C18H21NO3 C4H6O6 2½H2O; Molecular weight: 494.49. Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform. The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyethylene oxide, polysorbate 80, polyvinyl alcohol, talc, and titanium dioxide. The 30 mg tablets also contain iron oxide red and iron oxide yellow. The 40 mg tablets also contain iron oxide red. The 60 mg tablets also contain FD&C Blue #2. The 80 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 100 mg tablets also contain FD&C Blue #2 and iron oxide yellow. The 120 mg tablets also contain iron oxide yellow. The tablet imprinting ink contains ammonium hydroxide, butyl alcohol, iron oxide black, isopropyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "54868-1037-1",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-1037-1)",
"NDC11Code": "54868-1037-01",
"ProductNDC": "54868-1037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074359",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.",
"Description": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP ……………………..50 mgaspirin, USP ……………………....325 mgcaffeine, USP ………………………40 mgcodeine phosphate, USP …………30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula. C18H24NO7P anhydrous molecular weight 397.37. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide."
},
{
"NDCCode": "54868-1037-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-1037-3)",
"NDC11Code": "54868-1037-03",
"ProductNDC": "54868-1037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074359",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.",
"Description": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP ……………………..50 mgaspirin, USP ……………………....325 mgcaffeine, USP ………………………40 mgcodeine phosphate, USP …………30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula. C18H24NO7P anhydrous molecular weight 397.37. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50580-397-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-397-40) > 40 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0397-40</NDC11Code>
<ProductNDC>50580-397</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imodium</ProprietaryName>
<ProprietaryNameSuffix>A-d</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020448</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>10812-397-90</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10812-397-90) * 50 mL in 1 TUBE * 40 mL in 1 TUBE * 150 mL in 1 TUBE</PackageDescription>
<NDC11Code>10812-0397-90</NDC11Code>
<ProductNDC>10812-397</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Complete Acne Therapy System</ProprietaryName>
<NonProprietaryName>Salicylic Acid, Octinoxate, Zinc Oxide, And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120523</StartMarketingDate>
<EndMarketingDate>20160315</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-03-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>63833-387-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (63833-387-02) * 40 mL in 1 VIAL, SINGLE-USE (63833-397-01) * 40 mL in 1 VIAL, SINGLE-USE (63833-761-40) </PackageDescription>
<NDC11Code>63833-0387-02</NDC11Code>
<ProductNDC>63833-387</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kcentra</ProprietaryName>
<NonProprietaryName>Prothrombin, Coagulation Factor Vii Human, Coagulation Factor Ix Human, Coagulation Factor X Human, Protein C, Protein S Human, And Water</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131213</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125421</ApplicationNumber>
<LabelerName>CSL Behring GmbH</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KCENTRA, (Prothrombin Complex Concentrate (Human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: 1 acute major bleeding or, 2 need for an urgent surgery/invasive procedure.</IndicationAndUsage>
<Description>KCENTRA is a purified, heat-treated, nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate (Human) prepared from human U.S. Source Plasma (21 CFR 640.60). It contains the Vitamin K dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S. Factor IX is the lead factor for the potency of the preparation as stated on the vial label. The excipients are human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate. KCENTRA is sterile, pyrogen-free, and does not contain preservatives. The product contents are shown in Table 6 and listed as ranges for the blood coagulation factors. All plasma used in the manufacture of KCENTRA is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV, and HBV, and found to be non-reactive (negative), and the plasma is also tested by NAT for human parvovirus B19 (B19V) in order to exclude donations with high titers. The limit for B19V in the fractionation pool is set not to exceed 104 units of B19V DNA per mL. Only plasma that passed virus screening is used for production. The KCENTRA manufacturing process includes various steps, which contribute towards the reduction/inactivation of viruses. KCENTRA is manufactured from cryo-depleted plasma that is adsorbed via ion exchange chromatography, heat treated in aqueous solution for 10 hours at 60°C, precipitated, adsorbed to calcium phosphate, virus filtered, and lyophilized. Manufacturing steps were independently validated in a series of in vitro experiments for their virus inactivation / reduction capacity for both enveloped and non-enveloped viruses. Table 7 shows the virus clearance during the manufacturing process for KCENTRA, expressed as the mean log10 reduction factor.</Description>
</NDC>
<NDC>
<NDCCode>50580-397-20</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-397-20) > 20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0397-20</NDC11Code>
<ProductNDC>50580-397</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imodium</ProprietaryName>
<ProprietaryNameSuffix>A-d</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020448</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-397-25</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-397-25) > 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0397-25</NDC11Code>
<ProductNDC>50580-397</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imodium</ProprietaryName>
<ProprietaryNameSuffix>A-d</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020448</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-397-41</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-397-41) > 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0397-41</NDC11Code>
<ProductNDC>50580-397</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imodium</ProprietaryName>
<ProprietaryNameSuffix>A-d</ProprietaryNameSuffix>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020448</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-176-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-176-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0176-40</NDC11Code>
<ProductNDC>50580-176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div. McNeil-PPC, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-244-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-244-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0244-40</NDC11Code>
<ProductNDC>50580-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div McNeil-PPC, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-09-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-469-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-469-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0469-40</NDC11Code>
<ProductNDC>50580-469</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Extra Strength</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-482-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-482-40) > 40 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0482-40</NDC11Code>
<ProductNDC>50580-482</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910424</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>McNeil Consumer Healthcare Div McNeil-PPC, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>50580-563-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50580-563-40) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0563-40</NDC11Code>
<ProductNDC>50580-563</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin</ProprietaryName>
<ProprietaryNameSuffix>Pm</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079113</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division</LabelerName>
<SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
<StrengthNumber>200; 38</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50580-726-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50580-0726-40</NDC11Code>
<ProductNDC>50580-726</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zyrtec Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019835</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-726-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0726-72</NDC11Code>
<ProductNDC>50580-726</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zyrtec Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019835</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-779-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (50580-779-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0779-40</NDC11Code>
<ProductNDC>50580-779</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zyrtec</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100208</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022429</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100208</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-786-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0786-40</NDC11Code>
<ProductNDC>50580-786</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zyrtec Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213105</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-786-41</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0786-41</NDC11Code>
<ProductNDC>50580-786</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zyrtec Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213105</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0132-0194-14</NDCCode>
<PackageDescription>397 g in 1 JAR (0132-0194-14) </PackageDescription>
<NDC11Code>00132-0194-14</NDC11Code>
<ProductNDC>0132-0194</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boudreauxs</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0132-0323-14</NDCCode>
<PackageDescription>397 g in 1 JAR (0132-0323-14) </PackageDescription>
<NDC11Code>00132-0323-14</NDC11Code>
<ProductNDC>0132-0323</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boudreauxs</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/113g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0722-6094-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0722-6094-01) </PackageDescription>
<NDC11Code>00722-6094-01</NDC11Code>
<ProductNDC>0722-6094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ascomp With Codeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Cafeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075231</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>ASCOMP with CODEINE (butalbital, aspirin, caffeine, and codeine phosphate, USP) is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:. Butalbital, USP……………..50mg. Aspirin, USP………………..325mg. Caffeine, USP………………40mg. Codeine phosphate, USP…...30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has a molecular formula of: C11H16N2O3, with a molecular weight of 224.26, and the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has a molecular formula of C9H8O4 with a molecular weight of 180.6, and the following structural formula:. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has a molecular formula of C8H10N4O2 with a molecular weight of 194.19, and the following structural formula:. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has a molecular formula of C18H24NO7P with an anhydrous molecular weight of 397.37, and the following structural formula:. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0722-6094-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0722-6094-05) </PackageDescription>
<NDC11Code>00722-6094-05</NDC11Code>
<ProductNDC>0722-6094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ascomp With Codeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Cafeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075231</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>ASCOMP with CODEINE (butalbital, aspirin, caffeine, and codeine phosphate, USP) is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:. Butalbital, USP……………..50mg. Aspirin, USP………………..325mg. Caffeine, USP………………40mg. Codeine phosphate, USP…...30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has a molecular formula of: C11H16N2O3, with a molecular weight of 224.26, and the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has a molecular formula of C9H8O4 with a molecular weight of 180.6, and the following structural formula:. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has a molecular formula of C8H10N4O2 with a molecular weight of 194.19, and the following structural formula:. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has a molecular formula of C18H24NO7P with an anhydrous molecular weight of 397.37, and the following structural formula:. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>13668-397-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-397-05) </PackageDescription>
<NDC11Code>13668-0397-05</NDC11Code>
<ProductNDC>13668-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-397-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-397-30) </PackageDescription>
<NDC11Code>13668-0397-30</NDC11Code>
<ProductNDC>13668-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-397-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (13668-397-90) </PackageDescription>
<NDC11Code>13668-0397-90</NDC11Code>
<ProductNDC>13668-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic 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 ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>47335-046-40</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (47335-046-40) > 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>47335-0046-40</NDC11Code>
<ProductNDC>47335-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202922</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for.</IndicationAndUsage>
<Description>Oxaliplatin injection is an antineoplastic agent with the molecular formula C8H14N2O4Ptand the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP is for intravenous use. Each mL of oxaliplatin injection contains 5 mg of oxaliplatin, USP. It is supplied as a sterile, preservative-free, aqueous solution in 50 mg/10 mL and 100 mg/20 mL vials. Water for injection is present as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>47335-047-40</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (47335-047-40) > 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>47335-0047-40</NDC11Code>
<ProductNDC>47335-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202922</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for.</IndicationAndUsage>
<Description>Oxaliplatin injection is an antineoplastic agent with the molecular formula C8H14N2O4Ptand the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP is for intravenous use. Each mL of oxaliplatin injection contains 5 mg of oxaliplatin, USP. It is supplied as a sterile, preservative-free, aqueous solution in 50 mg/10 mL and 100 mg/20 mL vials. Water for injection is present as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>47335-176-40</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (47335-176-40) > 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>47335-0176-40</NDC11Code>
<ProductNDC>47335-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078818</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer.</IndicationAndUsage>
<Description>Oxaliplatin for injection USP is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin for injection USP is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.</Description>
</NDC>
<NDC>
<NDCCode>47335-178-40</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (47335-178-40) > 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>47335-0178-40</NDC11Code>
<ProductNDC>47335-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078818</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer.</IndicationAndUsage>
<Description>Oxaliplatin for injection USP is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin for injection USP is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.</Description>
</NDC>
<NDC>
<NDCCode>47781-397-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-397-60) </PackageDescription>
<NDC11Code>47781-0397-60</NDC11Code>
<ProductNDC>47781-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208269</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Hydrocodone bitartrate extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist. Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is. Empirical formula: C18H21NO3 C4H6O6 2½H2O; Molecular weight: 494.49. Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform. The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyethylene oxide, polysorbate 80, polyvinyl alcohol, talc, and titanium dioxide. The 30 mg tablets also contain iron oxide red and iron oxide yellow. The 40 mg tablets also contain iron oxide red. The 60 mg tablets also contain FD&C Blue #2. The 80 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 100 mg tablets also contain FD&C Blue #2 and iron oxide yellow. The 120 mg tablets also contain iron oxide yellow. The tablet imprinting ink contains ammonium hydroxide, butyl alcohol, iron oxide black, isopropyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>54868-1037-1</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (54868-1037-1)</PackageDescription>
<NDC11Code>54868-1037-01</NDC11Code>
<ProductNDC>54868-1037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074359</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP ……………………..50 mgaspirin, USP ……………………....325 mgcaffeine, USP ………………………40 mgcodeine phosphate, USP …………30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula. C18H24NO7P anhydrous molecular weight 397.37. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-1037-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (54868-1037-3)</PackageDescription>
<NDC11Code>54868-1037-03</NDC11Code>
<ProductNDC>54868-1037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074359</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP ……………………..50 mgaspirin, USP ……………………....325 mgcaffeine, USP ………………………40 mgcodeine phosphate, USP …………30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula. C18H24NO7P anhydrous molecular weight 397.37. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide.</Description>
</NDC>
</NDCList>