{
"NDC": [
{
"NDCCode": "63736-200-92",
"PackageDescription": "125 POUCH in 1 BOX (63736-200-92) / 1 TABLET in 1 POUCH",
"NDC11Code": "63736-0200-92",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090625",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-04",
"PackageDescription": "1 BLISTER PACK in 1 BOX (63736-200-04) > 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "63736-0200-04",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090625",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-30",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-200-30) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "63736-0200-30",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090625",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-50",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-200-50) / 50 TABLET in 1 BOTTLE",
"NDC11Code": "63736-0200-50",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090625",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-90",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-200-90) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "63736-0200-90",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090625",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-91",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-200-91) > 130 TABLET in 1 BOTTLE",
"NDC11Code": "63736-0200-91",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090625",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-93",
"PackageDescription": "1 BOTTLE in 1 BOX (63736-200-93) / 300 TABLET in 1 BOTTLE",
"NDC11Code": "63736-0200-93",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090625",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "63736-200-95",
"PackageDescription": "750 POUCH in 1 BOX (63736-200-95) > 1 TABLET in 1 POUCH",
"NDC11Code": "63736-0200-95",
"ProductNDC": "63736-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anacin",
"NonProprietaryName": "Asprin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "400; 32",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090625",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps."
},
{
"NDCCode": "0067-2030-92",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0067-2030-92) > 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00067-2030-92",
"ProductNDC": "0067-2030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060927",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Novartis Consumer Health, Inc.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "0067-2039-92",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2039-92) / 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2039-92",
"ProductNDC": "0067-2039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Migraine",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid) And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020802",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100215",
"SamplePackage": "N",
"IndicationAndUsage": "treats migraine."
},
{
"NDCCode": "0067-8103-92",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-8103-92) > 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-8103-92",
"ProductNDC": "0067-8103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Migraine",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid) And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075794",
"LabelerName": "Novartis Consumer Health, Inc.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
},
{
"NDCCode": "0067-8104-92",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-8104-92) > 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-8104-92",
"ProductNDC": "0067-8104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Caplets",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Novartis Consumer Health, Inc.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0944-2658-04",
"PackageDescription": "1 KIT in 1 CARTON (0944-2658-04) * 192 mL in 1 BOTTLE (0338-0001-37) * 192 mL in 1 BOTTLE (64764-511-92) * 200 mL in 1 BOTTLE (0944-2659-08) ",
"NDC11Code": "00944-2658-04",
"ProductNDC": "0944-2658",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Gammagard",
"ProprietaryNameSuffix": "S/d",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "19940510",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103133",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19940510",
"SamplePackage": "N",
"IndicationAndUsage": "GAMMAGARD S/D is an Immune Globulin Intravenous (Human) indicated for: 1 Treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older. (1), 2 Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). (1), 3 Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. (1), 4 Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1).",
"Description": "GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution (IgA < 1 µg/mL), is GAMMAGARD S/D selected to have an IgA concentration of less than 1 µg/mL of IgA in a 5% solution. GAMMAGARD S/D is a solvent/detergent treated, sterile, freeze-dried preparation of purified immunoglobulin G (IgG) derived from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography steps. The distribution of IgG subclasses present in this product is similar to that in normal plasma. The Fc portion is maintained intact. When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied and reconstituted to 5% solution, the product contains approximately 50 mg/mL of protein, of which at least 90% is gamma globulin. GAMMAGARD S/D contains < 1 µg/mL of IgA in a 5% solution and IgM is present in trace amounts. GAMMAGARD S/D contains all of the IgG antibody activities which are present in the donor population. The product, after reconstituted to 5% solution, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. GAMMAGARD S/D contains no preservative. To prepare a 10% (100 mg/mL) solution for infusion, add half the volume of diluent, as described in Dosage and Administration (2.1). The content of the stabilizing agents and other components, including IgA, for the 10% solution will be doubled compared to the 5% solution. Screening against potentially infectious agents in the product begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD S/D is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (HIV-1/HIV-2) and hepatitis C virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed nucleic acid testing (NAT) and found negative. The manufacturing process includes treatment with an organic solvent/detergent mixture12,13, composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80. The GAMMAGARD S/D manufacturing process provides for viral reduction in in vitro studies. These studies, summarized in Table 6 demonstrate virus clearance during GAMMAGARD S/D manufacturing using human immunodeficiency virus, Type 1 (HIV-1), as the relevant virus and model for HIV-2; bovine viral diarrhea virus (BVDV), a model virus for enveloped RNA viruses such as hepatitis C virus (HCV); pseudorabies virus (PRV), a generic model virus for enveloped DNA viruses such as hepatitis B virus (HBV); encephalomyocarditis virus (EMCV), a model for non-enveloped RNA viruses such as hepatitis A virus (HAV); HAV; and mice minute virus (MMV), a model for small non-enveloped DNA viruses such as human parvovirus B19 (B19V). These reductions are achieved through partitioning and inactivation during cold ethanol fractionation, and the solvent/detergent treatment."
},
{
"NDCCode": "17478-082-92",
"PackageDescription": "6 BOTTLE in 1 CARTON (17478-082-92) > 200 mL in 1 BOTTLE",
"NDC11Code": "17478-0082-92",
"ProductNDC": "17478-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20180316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204636",
"LabelerName": "Akorn",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180316",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally. Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following molecular formula of C17H26N2OHClH2O, molecular weight of 328.89 and the following structural formula. At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection is preservative-free and is available in a single dose container in 2 mg/mL (0.2%) concentration. The specific gravity of Ropivacaine Hydrochloride Injection solutions range from 1.00 to 1.01 at 25°C."
},
{
"NDCCode": "44206-438-20",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (44206-438-20) / 200 mL in 1 VIAL, GLASS (44206-438-92) ",
"NDC11Code": "44206-0438-20",
"ProductNDC": "44206-438",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Privigen",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090120",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125201",
"LabelerName": "CSL Behring AG",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "20",
"StrengthUnit": "g/200mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090120",
"SamplePackage": "N",
"IndicationAndUsage": "PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.",
"Description": "PRIVIGEN is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. PRIVIGEN has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. PRIVIGEN contains ≤25 mcg/mL IgA. The IgG subclass distribution is similar to that of normal human plasma. PRIVIGEN has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0). PRIVIGEN contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. PRIVIGEN contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. PRIVIGEN is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). PRIVIGEN does not activate the complement system or prekallikrein in an unspecific manner. To specifically reduce blood group A and B antibodies (isoagglutinins A and B) the manufacturing process for PRIVIGEN includes an immunoaffinity chromatography step. All plasma units used in the manufacture of PRIVIGEN have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for PRIVIGEN includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for PRIVIGEN, expressed as the mean log10 reduction factor (LRF)."
},
{
"NDCCode": "49230-200-92",
"PackageDescription": "5 BAG in 1 CARTON (49230-200-92) > 2000 mL in 1 BAG",
"NDC11Code": "49230-0200-92",
"ProductNDC": "49230-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "2.5; 538; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "60760-200-92",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (60760-200-92)",
"NDC11Code": "60760-0200-92",
"ProductNDC": "60760-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040777",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-03-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "86994-007-16",
"PackageDescription": "200 PATCH in 1 PACKAGE (86994-007-16) > 2.92 g in 1 PATCH (86994-007-15) ",
"NDC11Code": "86994-0007-16",
"ProductNDC": "86994-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laramed Antibacterial Alcohol Wipes",
"NonProprietaryName": "Alcohol, Isopropanol, Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI",
"SubstanceName": "ALCOHOL; ISOPROPYL ALCOHOL; BENZALKONIUM CHLORIDE",
"StrengthNumber": "65; 10; .05",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "0037-0521-92",
"PackageDescription": "100 TABLET in 1 BOTTLE (0037-0521-92)",
"NDC11Code": "00037-0521-92",
"ProductNDC": "0037-0521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lufyllin",
"NonProprietaryName": "Dyphylline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19760831",
"EndMarketingDate": "20160229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084566",
"LabelerName": "Meda Pharmaceuticals Inc.",
"SubstanceName": "DYPHYLLINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-03-04"
},
{
"NDCCode": "0056-0474-92",
"PackageDescription": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0474-92) ",
"NDC11Code": "00056-0474-92",
"ProductNDC": "0056-0474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sustiva",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020972",
"LabelerName": "Bristol-Myers Squibb Pharma Company",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19980917",
"SamplePackage": "N"
},
{
"NDCCode": "0078-1035-92",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94) ",
"NDC11Code": "00078-1035-92",
"ProductNDC": "0078-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vijoice",
"NonProprietaryName": "Alpelisib",
"DosageFormName": "KIT",
"StartMarketingDate": "20220405",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215039",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220405",
"SamplePackage": "Y",
"IndicationAndUsage": "VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "VIJOICE (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The pH of a 1.0% (m/V) solution of alpelisib in water/ethanol (50:50 V/V) is approximately 6.2. The chemical structure of alpelisib is shown below. VIJOICE film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 125 mg, and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide red (applicable only to 50 mg and 200 mg strengths), iron oxide yellow, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide. VIJOICE oral granules are supplied for oral administration with one strength that contains 50 mg of alpelisib. The granules also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "0173-0882-10",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-10",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-14",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0882-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0882-61",
"ProductNDC": "0173-0882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breo Ellipta",
"NonProprietaryName": "Fluticasone Furoate And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204275",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).",
"Description": "BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0893-10",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0893-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER",
"NDC11Code": "00173-0893-10",
"ProductNDC": "0173-0893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209482",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200909",
"SamplePackage": "N",
"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0893-14",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
"NDC11Code": "00173-0893-14",
"ProductNDC": "0173-0893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
"DosageFormName": "POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209482",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
"StrengthNumber": "200; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0173-0893-61",
"PackageDescription": "1 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER",
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"ProductNDC": "0173-0893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trelegy Ellipta",
"NonProprietaryName": "Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate",
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"MarketingCategoryName": "NDA",
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"LabelerName": "GlaxoSmithKline LLC",
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"StrengthNumber": "200; 62.5; 25",
"StrengthUnit": "ug/1; ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "Y",
"IndicationAndUsage": "TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).",
"Description": "TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "0310-9500-01",
"PackageDescription": "64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01) ",
"NDC11Code": "00310-9500-01",
"ProductNDC": "0310-9500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Truqap",
"NonProprietaryName": "Capivasertib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231116",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218197",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "CAPIVASERTIB",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-26",
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"IndicationAndUsage": "TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).",
"Description": "TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide."
},
{
"NDCCode": "0310-9500-02",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).",
"Description": "TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide."
},
{
"NDCCode": "0310-9501-01",
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"IndicationAndUsage": "TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).",
"Description": "TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide."
}
]
}
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</NDC>
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<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>400; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-200-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63736-200-90) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>63736-0200-90</NDC11Code>
<ProductNDC>63736-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<NonProprietaryName>Asprin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>400; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-200-91</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63736-200-91) > 130 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>63736-0200-91</NDC11Code>
<ProductNDC>63736-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<NonProprietaryName>Asprin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>400; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-200-93</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63736-200-93) / 300 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>63736-0200-93</NDC11Code>
<ProductNDC>63736-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<NonProprietaryName>Asprin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>400; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63736-200-95</NDCCode>
<PackageDescription>750 POUCH in 1 BOX (63736-200-95) > 1 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>63736-0200-95</NDC11Code>
<ProductNDC>63736-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anacin</ProprietaryName>
<NonProprietaryName>Asprin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>400; 32</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to : 1 Headache, 2 toothache , 3 muscular aches , 4 a cold, 5 backache , 6 arthritis, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2030-92</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0067-2030-92) > 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00067-2030-92</NDC11Code>
<ProductNDC>0067-2030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0067-2039-92</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2039-92) / 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2039-92</NDC11Code>
<ProductNDC>0067-2039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Migraine</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid) And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020802</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats migraine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-8103-92</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-8103-92) > 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-8103-92</NDC11Code>
<ProductNDC>0067-8103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Migraine</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid) And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075794</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0067-8104-92</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-8104-92) > 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-8104-92</NDC11Code>
<ProductNDC>0067-8104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0944-2658-04</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2658-04) * 192 mL in 1 BOTTLE (0338-0001-37) * 192 mL in 1 BOTTLE (64764-511-92) * 200 mL in 1 BOTTLE (0944-2659-08) </PackageDescription>
<NDC11Code>00944-2658-04</NDC11Code>
<ProductNDC>0944-2658</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Gammagard</ProprietaryName>
<ProprietaryNameSuffix>S/d</ProprietaryNameSuffix>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19940510</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103133</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GAMMAGARD S/D is an Immune Globulin Intravenous (Human) indicated for: 1 Treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older. (1), 2 Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). (1), 3 Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. (1), 4 Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1).</IndicationAndUsage>
<Description>GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution (IgA < 1 µg/mL), is GAMMAGARD S/D selected to have an IgA concentration of less than 1 µg/mL of IgA in a 5% solution. GAMMAGARD S/D is a solvent/detergent treated, sterile, freeze-dried preparation of purified immunoglobulin G (IgG) derived from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography steps. The distribution of IgG subclasses present in this product is similar to that in normal plasma. The Fc portion is maintained intact. When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied and reconstituted to 5% solution, the product contains approximately 50 mg/mL of protein, of which at least 90% is gamma globulin. GAMMAGARD S/D contains < 1 µg/mL of IgA in a 5% solution and IgM is present in trace amounts. GAMMAGARD S/D contains all of the IgG antibody activities which are present in the donor population. The product, after reconstituted to 5% solution, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL polysorbate 80. GAMMAGARD S/D contains no preservative. To prepare a 10% (100 mg/mL) solution for infusion, add half the volume of diluent, as described in Dosage and Administration (2.1). The content of the stabilizing agents and other components, including IgA, for the 10% solution will be doubled compared to the 5% solution. Screening against potentially infectious agents in the product begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD S/D is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (HIV-1/HIV-2) and hepatitis C virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed nucleic acid testing (NAT) and found negative. The manufacturing process includes treatment with an organic solvent/detergent mixture12,13, composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80. The GAMMAGARD S/D manufacturing process provides for viral reduction in in vitro studies. These studies, summarized in Table 6 demonstrate virus clearance during GAMMAGARD S/D manufacturing using human immunodeficiency virus, Type 1 (HIV-1), as the relevant virus and model for HIV-2; bovine viral diarrhea virus (BVDV), a model virus for enveloped RNA viruses such as hepatitis C virus (HCV); pseudorabies virus (PRV), a generic model virus for enveloped DNA viruses such as hepatitis B virus (HBV); encephalomyocarditis virus (EMCV), a model for non-enveloped RNA viruses such as hepatitis A virus (HAV); HAV; and mice minute virus (MMV), a model for small non-enveloped DNA viruses such as human parvovirus B19 (B19V). These reductions are achieved through partitioning and inactivation during cold ethanol fractionation, and the solvent/detergent treatment.</Description>
</NDC>
<NDC>
<NDCCode>17478-082-92</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (17478-082-92) > 200 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>17478-0082-92</NDC11Code>
<ProductNDC>17478-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20180316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204636</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally. Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following molecular formula of C17H26N2OHClH2O, molecular weight of 328.89 and the following structural formula. At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection is preservative-free and is available in a single dose container in 2 mg/mL (0.2%) concentration. The specific gravity of Ropivacaine Hydrochloride Injection solutions range from 1.00 to 1.01 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>44206-438-20</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (44206-438-20) / 200 mL in 1 VIAL, GLASS (44206-438-92) </PackageDescription>
<NDC11Code>44206-0438-20</NDC11Code>
<ProductNDC>44206-438</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Privigen</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090120</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125201</ApplicationNumber>
<LabelerName>CSL Behring AG</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/200mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.</IndicationAndUsage>
<Description>PRIVIGEN is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. PRIVIGEN has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. PRIVIGEN contains ≤25 mcg/mL IgA. The IgG subclass distribution is similar to that of normal human plasma. PRIVIGEN has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0). PRIVIGEN contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. PRIVIGEN contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. PRIVIGEN is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). PRIVIGEN does not activate the complement system or prekallikrein in an unspecific manner. To specifically reduce blood group A and B antibodies (isoagglutinins A and B) the manufacturing process for PRIVIGEN includes an immunoaffinity chromatography step. All plasma units used in the manufacture of PRIVIGEN have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL. The manufacturing process for PRIVIGEN includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity. These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 6 shows the virus clearance during the manufacturing process for PRIVIGEN, expressed as the mean log10 reduction factor (LRF).</Description>
</NDC>
<NDC>
<NDCCode>49230-200-92</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (49230-200-92) > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0200-92</NDC11Code>
<ProductNDC>49230-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19841130</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018883</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5; 538; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>60760-200-92</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (60760-200-92)</PackageDescription>
<NDC11Code>60760-0200-92</NDC11Code>
<ProductNDC>60760-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040777</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>86994-007-16</NDCCode>
<PackageDescription>200 PATCH in 1 PACKAGE (86994-007-16) > 2.92 g in 1 PATCH (86994-007-15) </PackageDescription>
<NDC11Code>86994-0007-16</NDC11Code>
<ProductNDC>86994-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laramed Antibacterial Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol, Isopropanol, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI</LabelerName>
<SubstanceName>ALCOHOL; ISOPROPYL ALCOHOL; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>65; 10; .05</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0037-0521-92</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0037-0521-92)</PackageDescription>
<NDC11Code>00037-0521-92</NDC11Code>
<ProductNDC>0037-0521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lufyllin</ProprietaryName>
<NonProprietaryName>Dyphylline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760831</StartMarketingDate>
<EndMarketingDate>20160229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084566</ApplicationNumber>
<LabelerName>Meda Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DYPHYLLINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-03-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0056-0474-92</NDCCode>
<PackageDescription>90 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0474-92) </PackageDescription>
<NDC11Code>00056-0474-92</NDC11Code>
<ProductNDC>0056-0474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sustiva</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020972</ApplicationNumber>
<LabelerName>Bristol-Myers Squibb Pharma Company</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-1035-92</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94) </PackageDescription>
<NDC11Code>00078-1035-92</NDC11Code>
<ProductNDC>0078-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vijoice</ProprietaryName>
<NonProprietaryName>Alpelisib</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220405</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215039</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220405</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>VIJOICE (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The pH of a 1.0% (m/V) solution of alpelisib in water/ethanol (50:50 V/V) is approximately 6.2. The chemical structure of alpelisib is shown below. VIJOICE film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 125 mg, and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide red (applicable only to 50 mg and 200 mg strengths), iron oxide yellow, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide. VIJOICE oral granules are supplied for oral administration with one strength that contains 50 mg of alpelisib. The granules also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-10</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-10</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-14</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-14</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0882-61</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0882-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0882-61</NDC11Code>
<ProductNDC>0173-0882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Breo Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204275</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 5 years and older. (1.2).</IndicationAndUsage>
<Description>BREO ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS) and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.5, 12.4 or 12.3 mg, respectively), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, BREO ELLIPTA delivers 46, 92 or 184 mcg of fluticasone furoate and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult patients with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC <70% and FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). In adult patients with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). In pediatric patients with asthma aged 5 to 11 years, mean peak inspiratory flow through the ELLIPTA inhaler was 60.6 L/min (range: 36.3 to 82.5 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>0173-0893-10</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (0173-0893-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER</PackageDescription>
<NDC11Code>00173-0893-10</NDC11Code>
<ProductNDC>0173-0893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trelegy Ellipta</ProprietaryName>
<NonProprietaryName>Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209482</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE</SubstanceName>
<StrengthNumber>200; 62.5; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
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<NDC>
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<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
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<ProductNDC>0173-0893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<IndicationAndUsage>TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: 1 the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1), 2 the maintenance treatment of asthma in patients aged 18 years and older. (1.2).</IndicationAndUsage>
<Description>TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure. Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure. Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV1/FVC [forced vital capacity] <70% and FEV1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8 L/min (range: 43.5 to 94.1 L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was 96.6 L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
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<NDCCode>0310-9500-01</NDCCode>
<PackageDescription>64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01) </PackageDescription>
<NDC11Code>00310-9500-01</NDC11Code>
<ProductNDC>0310-9500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Truqap</ProprietaryName>
<NonProprietaryName>Capivasertib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231116</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218197</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>CAPIVASERTIB</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<IndicationAndUsage>TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).</IndicationAndUsage>
<Description>TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide.</Description>
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<NDCCode>0310-9500-02</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>0310-9500</ProductNDC>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).</IndicationAndUsage>
<Description>TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide.</Description>
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<IndicationAndUsage>TRUQAP is a kinase inhibitor indicated:. HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer: 1 in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1.1).</IndicationAndUsage>
<Description>TRUQAP (capivasertib) is a kinase inhibitor. The molecular formula for capivasertib is C21H25ClN6O2 and the molecular weight is 428.92 g/mol. The chemical name of capivasertib is 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide. Capivasertib is freely soluble in water at pH values below 1.2 and practically insoluble at pH values above 6.8. Capivasertib has the following structural formula. TRUQAP film-coated tablets are supplied for oral administration with 160 mg or 200 mg capivasertib. The tablets also contain croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. The film coat contains the following inactive ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide.</Description>
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