{
"NDC": [
{
"NDCCode": "68462-545-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-545-08)",
"NDC11Code": "68462-0545-08",
"ProductNDC": "68462-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "21749-545-08",
"PackageDescription": "236 mL in 1 PACKAGE (21749-545-08) ",
"NDC11Code": "21749-0545-08",
"ProductNDC": "21749-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signatry Antibacterial Plum Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": " Handwash to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "49035-545-08",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (49035-545-08) ",
"NDC11Code": "49035-0545-08",
"ProductNDC": "49035-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Childrens Multi Symptoms",
"ProprietaryNameSuffix": "Cold And Cough Multi-symptom Relief",
"NonProprietaryName": "Chlorpheniramine Maleate And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "WAL-MART STORES,INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 15",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cold symptoms: 1 cough due to minor throat & bronchial irritation, 2 sneezing, 3 runny nose."
},
{
"NDCCode": "50241-028-08",
"PackageDescription": "545.82 g in 1 BOTTLE, PLASTIC (50241-028-08) ",
"NDC11Code": "50241-0028-08",
"ProductNDC": "50241-028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D7 Decon Seven",
"NonProprietaryName": "N/a",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Morgan Gallacher Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200309",
"SamplePackage": "N"
},
{
"NDCCode": "68382-545-08",
"PackageDescription": "10 VIAL in 1 TRAY (68382-545-08) > 20 mL in 1 VIAL",
"NDC11Code": "68382-0545-08",
"ProductNDC": "68382-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etomidate",
"NonProprietaryName": "Etomidate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202360",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ETOMIDATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Etomidate injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate injection, USP the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate injection, USP is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.",
"Description": "Etomidate injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, USP 2 mg, propylene glycol, USP 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenylethyl)-1H-imidazole -5-carboxylate and has the following structural formula. The molecular formula is C14H16N2O2, representing a molecular weight of 244.3."
},
{
"NDCCode": "71919-545-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-545-08) ",
"NDC11Code": "71919-0545-08",
"ProductNDC": "71919-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Platinum Metallicum",
"NonProprietaryName": "Platinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20101007",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PLATINUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101007",
"SamplePackage": "N"
},
{
"NDCCode": "80106-545-08",
"PackageDescription": "236 mL in 1 BOTTLE (80106-545-08) ",
"NDC11Code": "80106-0545-08",
"ProductNDC": "80106-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "1stopresourcegroup",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "68462-135-08",
"PackageDescription": "120 TABLET in 1 BOTTLE (68462-135-08) ",
"NDC11Code": "68462-0135-08",
"ProductNDC": "68462-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209227",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191016",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "68462-546-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-546-08)",
"NDC11Code": "68462-0546-08",
"ProductNDC": "68462-546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-547-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-547-08)",
"NDC11Code": "68462-0547-08",
"ProductNDC": "68462-547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-713-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08) ",
"NDC11Code": "68462-0713-08",
"ProductNDC": "68462-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "68462-714-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-714-08) ",
"NDC11Code": "68462-0714-08",
"ProductNDC": "68462-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "70859-001-01",
"PackageDescription": "1 KIT in 1 KIT (70859-001-01) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) * 118 mL in 1 TUBE (68599-0203-4) ",
"NDC11Code": "70859-0001-01",
"ProductNDC": "70859-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nusurgepak Surgical Prep/carepak",
"NonProprietaryName": "Chlorhexidine Gluconate, Mupirocin, Dimethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20160729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090480",
"LabelerName": "Nucare Pharmaceuticals Inc",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160729",
"SamplePackage": "N"
},
{
"NDCCode": "70859-057-01",
"PackageDescription": "1 KIT in 1 KIT (70859-057-01) * 118 mg in 1 BOTTLE (68599-0213-4) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) ",
"NDC11Code": "70859-0057-01",
"ProductNDC": "70859-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nusurgepak Surgical Prep/carepak",
"NonProprietaryName": "Chlorhexidine Gluconate, Mupirocin, Dimethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20110608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090480",
"LabelerName": "Nucare Pharmaceuticals Inc",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"Description": "Mupirocin ointment USP 2% contains the RNA synthetase inhibitor antibacterial, mupirocin USP. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin USP is C 26H 44O 9, and the molecular weight is 500.6. The chemical structure is:. Each gram of mupirocin ointment USP 2% contains 20 mg mupirocin USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350."
},
{
"NDCCode": "0480-3273-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56) ",
"NDC11Code": "00480-3273-56",
"ProductNDC": "0480-3273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3274-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56) ",
"NDC11Code": "00480-3274-56",
"ProductNDC": "0480-3274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3275-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56) ",
"NDC11Code": "00480-3275-56",
"ProductNDC": "0480-3275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "0480-3276-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56) ",
"NDC11Code": "00480-3276-56",
"ProductNDC": "0480-3276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvaiz",
"NonProprietaryName": "Eltrombopag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216774",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "ELTROMBOPAG CHOLINE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240213",
"SamplePackage": "N",
"IndicationAndUsage": "ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating."
},
{
"NDCCode": "17156-251-08",
"PackageDescription": "1.5 mL in 1 VIAL, GLASS (17156-251-08) ",
"NDC11Code": "17156-0251-08",
"ProductNDC": "17156-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indium Dtpa In 111",
"NonProprietaryName": "Indium In-111 Pentetate Disodium",
"DosageFormName": "SOLUTION",
"RouteName": "INTRATHECAL",
"StartMarketingDate": "19820218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017707",
"LabelerName": "Medi-Physics, Inc. dba GE Healthcare",
"SubstanceName": "INDIUM IN-111 PENTETATE DISODIUM",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19820218",
"SamplePackage": "N",
"IndicationAndUsage": "Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.",
"Description": "GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 µg of pentetic acid, and sodium bicarbonate for pH adjustment. The drug is to be discarded after single use. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time. Graph 1 - Radionuclidic Impurities. The chemical names are 1. Indate(2-)-111In-[N,N-bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [N,N-bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-)111In. Molecular formula: C14H18O10N3 111In Na2. Molecular weight: 545.29. Structural formula."
},
{
"NDCCode": "43547-545-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-545-03) ",
"NDC11Code": "43547-0545-03",
"ProductNDC": "43547-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213273",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220731",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide."
},
{
"NDCCode": "43547-545-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-545-09) ",
"NDC11Code": "43547-0545-09",
"ProductNDC": "43547-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213273",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220731",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide."
},
{
"NDCCode": "43547-545-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (43547-545-10) ",
"NDC11Code": "43547-0545-10",
"ProductNDC": "43547-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213273",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220731",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide."
},
{
"NDCCode": "43547-545-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-545-11) ",
"NDC11Code": "43547-0545-11",
"ProductNDC": "43547-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213273",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220731",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide."
},
{
"NDCCode": "43547-545-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-545-50) ",
"NDC11Code": "43547-0545-50",
"ProductNDC": "43547-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213273",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220731",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.",
"Description": "Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide."
},
{
"NDCCode": "58411-545-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (58411-545-10) / 35 mL in 1 BOTTLE",
"NDC11Code": "58411-0545-10",
"ProductNDC": "58411-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Radiant Fluid Foundation",
"ProprietaryNameSuffix": "O70",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "2.72118",
"StrengthUnit": "g/35mL",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "59651-545-15",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (59651-545-15) / 15 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0545-15",
"ProductNDC": "59651-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216547",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "59651-545-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-545-30) ",
"NDC11Code": "59651-0545-30",
"ProductNDC": "59651-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216547",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "60923-545-54",
"PackageDescription": "1 KIT in 1 CARTON (60923-545-54) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 54 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0545-54",
"ProductNDC": "60923-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "61874-115-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) ",
"NDC11Code": "61874-0115-07",
"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-115-17",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "61874-0115-17",
"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>68462-545-08</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68462-545-08)</PackageDescription>
<NDC11Code>68462-0545-08</NDC11Code>
<ProductNDC>68462-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078234</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>21749-545-08</NDCCode>
<PackageDescription>236 mL in 1 PACKAGE (21749-545-08) </PackageDescription>
<NDC11Code>21749-0545-08</NDC11Code>
<ProductNDC>21749-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signatry Antibacterial Plum Foam Handwash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170614</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Handwash to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-545-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (49035-545-08) </PackageDescription>
<NDC11Code>49035-0545-08</NDC11Code>
<ProductNDC>49035-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Childrens Multi Symptoms</ProprietaryName>
<ProprietaryNameSuffix>Cold And Cough Multi-symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Chlorpheniramine Maleate And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>WAL-MART STORES,INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 15</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cold symptoms: 1 cough due to minor throat & bronchial irritation, 2 sneezing, 3 runny nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50241-028-08</NDCCode>
<PackageDescription>545.82 g in 1 BOTTLE, PLASTIC (50241-028-08) </PackageDescription>
<NDC11Code>50241-0028-08</NDC11Code>
<ProductNDC>50241-028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>D7 Decon Seven</ProprietaryName>
<NonProprietaryName>N/a</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Morgan Gallacher Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-545-08</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (68382-545-08) > 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>68382-0545-08</NDC11Code>
<ProductNDC>68382-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etomidate</ProprietaryName>
<NonProprietaryName>Etomidate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202360</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ETOMIDATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etomidate injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate injection, USP the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous etomidate injection, USP is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.</IndicationAndUsage>
<Description>Etomidate injection, USP is a sterile, nonpyrogenic solution. Each milliliter contains etomidate, USP 2 mg, propylene glycol, USP 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenylethyl)-1H-imidazole -5-carboxylate and has the following structural formula. The molecular formula is C14H16N2O2, representing a molecular weight of 244.3.</Description>
</NDC>
<NDC>
<NDCCode>71919-545-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-545-08) </PackageDescription>
<NDC11Code>71919-0545-08</NDC11Code>
<ProductNDC>71919-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Platinum Metallicum</ProprietaryName>
<NonProprietaryName>Platinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101007</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PLATINUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80106-545-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (80106-545-08) </PackageDescription>
<NDC11Code>80106-0545-08</NDC11Code>
<ProductNDC>80106-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>1stopresourcegroup</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68462-135-08</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68462-135-08) </PackageDescription>
<NDC11Code>68462-0135-08</NDC11Code>
<ProductNDC>68462-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209227</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>68462-546-08</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68462-546-08)</PackageDescription>
<NDC11Code>68462-0546-08</NDC11Code>
<ProductNDC>68462-546</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078234</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>68462-547-08</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68462-547-08)</PackageDescription>
<NDC11Code>68462-0547-08</NDC11Code>
<ProductNDC>68462-547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078234</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>68462-713-08</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08) </PackageDescription>
<NDC11Code>68462-0713-08</NDC11Code>
<ProductNDC>68462-713</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rufinamide</ProprietaryName>
<NonProprietaryName>Rufinamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205075</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>RUFINAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.</IndicationAndUsage>
<Description>Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-714-08</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (68462-714-08) </PackageDescription>
<NDC11Code>68462-0714-08</NDC11Code>
<ProductNDC>68462-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rufinamide</ProprietaryName>
<NonProprietaryName>Rufinamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205075</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>RUFINAMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.</IndicationAndUsage>
<Description>Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70859-001-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70859-001-01) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) * 118 mL in 1 TUBE (68599-0203-4) </PackageDescription>
<NDC11Code>70859-0001-01</NDC11Code>
<ProductNDC>70859-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nusurgepak Surgical Prep/carepak</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, Mupirocin, Dimethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090480</ApplicationNumber>
<LabelerName>Nucare Pharmaceuticals Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70859-057-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70859-057-01) * 118 mg in 1 BOTTLE (68599-0213-4) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) </PackageDescription>
<NDC11Code>70859-0057-01</NDC11Code>
<ProductNDC>70859-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nusurgepak Surgical Prep/carepak</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, Mupirocin, Dimethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090480</ApplicationNumber>
<LabelerName>Nucare Pharmaceuticals Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Mupirocin ointment USP 2% contains the RNA synthetase inhibitor antibacterial, mupirocin USP. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin USP is C 26H 44O 9, and the molecular weight is 500.6. The chemical structure is:. Each gram of mupirocin ointment USP 2% contains 20 mg mupirocin USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>0480-3273-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56) </PackageDescription>
<NDC11Code>00480-3273-56</NDC11Code>
<ProductNDC>0480-3273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3274-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56) </PackageDescription>
<NDC11Code>00480-3274-56</NDC11Code>
<ProductNDC>0480-3274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3275-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56) </PackageDescription>
<NDC11Code>00480-3275-56</NDC11Code>
<ProductNDC>0480-3275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>0480-3276-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56) </PackageDescription>
<NDC11Code>00480-3276-56</NDC11Code>
<ProductNDC>0480-3276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvaiz</ProprietaryName>
<NonProprietaryName>Eltrombopag</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216774</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG CHOLINE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVAIZ is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C30H35N5O5. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula. Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are. Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating.</Description>
</NDC>
<NDC>
<NDCCode>17156-251-08</NDCCode>
<PackageDescription>1.5 mL in 1 VIAL, GLASS (17156-251-08) </PackageDescription>
<NDC11Code>17156-0251-08</NDC11Code>
<ProductNDC>17156-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indium Dtpa In 111</ProprietaryName>
<NonProprietaryName>Indium In-111 Pentetate Disodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRATHECAL</RouteName>
<StartMarketingDate>19820218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017707</ApplicationNumber>
<LabelerName>Medi-Physics, Inc. dba GE Healthcare</LabelerName>
<SubstanceName>INDIUM IN-111 PENTETATE DISODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.</IndicationAndUsage>
<Description>GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 µg of pentetic acid, and sodium bicarbonate for pH adjustment. The drug is to be discarded after single use. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time. Graph 1 - Radionuclidic Impurities. The chemical names are 1. Indate(2-)-111In-[N,N-bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [N,N-bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-)111In. Molecular formula: C14H18O10N3 111In Na2. Molecular weight: 545.29. Structural formula.</Description>
</NDC>
<NDC>
<NDCCode>43547-545-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-545-03) </PackageDescription>
<NDC11Code>43547-0545-03</NDC11Code>
<ProductNDC>43547-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213273</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-545-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43547-545-09) </PackageDescription>
<NDC11Code>43547-0545-09</NDC11Code>
<ProductNDC>43547-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213273</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-545-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43547-545-10) </PackageDescription>
<NDC11Code>43547-0545-10</NDC11Code>
<ProductNDC>43547-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213273</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-545-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43547-545-11) </PackageDescription>
<NDC11Code>43547-0545-11</NDC11Code>
<ProductNDC>43547-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213273</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-545-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43547-545-50) </PackageDescription>
<NDC11Code>43547-0545-50</NDC11Code>
<ProductNDC>43547-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213273</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate, USP, is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>58411-545-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58411-545-10) / 35 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58411-0545-10</NDC11Code>
<ProductNDC>58411-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Radiant Fluid Foundation</ProprietaryName>
<ProprietaryNameSuffix>O70</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.72118</StrengthNumber>
<StrengthUnit>g/35mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-545-15</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (59651-545-15) / 15 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0545-15</NDC11Code>
<ProductNDC>59651-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216547</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>59651-545-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-545-30) </PackageDescription>
<NDC11Code>59651-0545-30</NDC11Code>
<ProductNDC>59651-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216547</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>60923-545-54</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-545-54) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 54 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0545-54</NDC11Code>
<ProductNDC>60923-545</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>61874-115-07</NDCCode>
<PackageDescription>7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) </PackageDescription>
<NDC11Code>61874-0115-07</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-115-17</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>61874-0115-17</NDC11Code>
<ProductNDC>61874-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
</NDCList>