{
"NDC": [
{
"NDCCode": "68196-145-80",
"PackageDescription": "2360 mL in 1 BOTTLE, PLASTIC (68196-145-80)",
"NDC11Code": "68196-0145-80",
"ProductNDC": "68196-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Right Body Care",
"ProprietaryNameSuffix": "Antibacterial",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121025",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.15",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "83711-145-27",
"PackageDescription": "80 g in 1 APPLICATOR (83711-145-27) ",
"NDC11Code": "83711-0145-27",
"ProductNDC": "83711-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suave Men Extra Fresh Roll On Antiperspirant",
"NonProprietaryName": "Antiperspirant Deodorant",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251023",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Suave Brands Co, LLC",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "17.6",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251023",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Reduces underarm wetness, 2 24 hour protection."
},
{
"NDCCode": "68196-140-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-140-80)",
"NDC11Code": "68196-0140-80",
"ProductNDC": "68196-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sp With Light Moisturizers",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-141-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-141-80)",
"NDC11Code": "68196-0141-80",
"ProductNDC": "68196-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sp With Light Moisturizers Refill",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-142-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-142-80)",
"NDC11Code": "68196-0142-80",
"ProductNDC": "68196-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"ProprietaryNameSuffix": "Light Moisturizers",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-143-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-143-80)",
"NDC11Code": "68196-0143-80",
"ProductNDC": "68196-143",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"ProprietaryNameSuffix": "Light Moisturizers Refill",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-144-80",
"PackageDescription": "2360 mL in 1 BOTTLE, PLASTIC (68196-144-80)",
"NDC11Code": "68196-0144-80",
"ProductNDC": "68196-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Right Body Care",
"ProprietaryNameSuffix": "Antibacterial",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.15",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-146-80",
"PackageDescription": "2360 mL in 1 BOTTLE, PLASTIC (68196-146-80)",
"NDC11Code": "68196-0146-80",
"ProductNDC": "68196-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Right Body Care",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130703",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.15",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-147-80",
"PackageDescription": "2360 mL in 1 BOTTLE, PLASTIC (68196-147-80)",
"NDC11Code": "68196-0147-80",
"ProductNDC": "68196-147",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Right Body Care",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130703",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "1.15",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "68196-149-80",
"PackageDescription": "2365 mL in 1 PACKAGE (68196-149-80)",
"NDC11Code": "68196-0149-80",
"ProductNDC": "68196-149",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Right",
"ProprietaryNameSuffix": "Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "HELPS ELIMINATE BACTERIA ON HANDS."
},
{
"NDCCode": "68196-225-80",
"PackageDescription": "2 BOTTLE in 1 CARTON (68196-225-80) > 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "68196-0225-80",
"ProductNDC": "68196-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206531",
"LabelerName": "Sam's West Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200227",
"SamplePackage": "N"
},
{
"NDCCode": "68196-432-80",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (68196-432-80) > 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68196-0432-80",
"ProductNDC": "68196-432",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Members Mark Nasal Decongestant",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Pseudoephedrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19990203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Sam's West Inc",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0002-9401-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-9401-01) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-9401-01",
"ProductNDC": "0002-9401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kisunla",
"NonProprietaryName": "Donanemab-azbt",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240702",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761248",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DONANEMAB",
"StrengthNumber": "17.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240702",
"SamplePackage": "N",
"IndicationAndUsage": "KISUNLATM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.",
"Description": "Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta, and is expressed in a Chinese hamster ovary cell line. Donanemab-azbt has an approximate molecular weight of 145 kDa. KISUNLA (donanemab-azbt) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for intravenous infusion after dilution. KISUNLA is supplied in single-dose vials available in a concentration of 350 mg/20 mL (17.5 mg/mL). Each mL of solution contains 17.5 mg donanemab-azbt, anhydrous citric acid (0.32 mg), polysorbate 80 (0.20 mg), sodium citrate (2.15 mg), sucrose (80 mg), and Water for Injection, USP, at a pH of 5.5 to 6.5."
},
{
"NDCCode": "0069-0238-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00069-0238-01",
"ProductNDC": "0069-0238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ruxience",
"NonProprietaryName": "Rituximab-pvvr",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761103",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
"Description": "Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "0069-0249-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00069-0249-01",
"ProductNDC": "0069-0249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ruxience",
"NonProprietaryName": "Rituximab-pvvr",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761103",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
"Description": "Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "0143-9168-01",
"PackageDescription": ".5 mL in 1 SYRINGE (0143-9168-01) ",
"NDC11Code": "00143-9168-01",
"ProductNDC": "0143-9168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9169-01",
"PackageDescription": ".5 mL in 1 VIAL (0143-9169-01) ",
"NDC11Code": "00143-9169-01",
"ProductNDC": "0143-9169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9170-01",
"PackageDescription": "1 mL in 1 SYRINGE (0143-9170-01) ",
"NDC11Code": "00143-9170-01",
"ProductNDC": "0143-9170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9171-01",
"PackageDescription": "26 mL in 1 VIAL (0143-9171-01) ",
"NDC11Code": "00143-9171-01",
"ProductNDC": "0143-9171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "130",
"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "13310-145-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (13310-145-01) ",
"NDC11Code": "13310-0145-01",
"ProductNDC": "13310-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bactrim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20041101",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017377",
"LabelerName": "AR Scientific, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041101",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "13310-145-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (13310-145-05) ",
"NDC11Code": "13310-0145-05",
"ProductNDC": "13310-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bactrim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20041101",
"EndMarketingDate": "20181228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017377",
"LabelerName": "AR Scientific, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041101",
"EndMarketingDatePackage": "20181228",
"SamplePackage": "N"
},
{
"NDCCode": "31722-145-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-145-05) ",
"NDC11Code": "31722-0145-05",
"ProductNDC": "31722-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214790",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red."
},
{
"NDCCode": "31722-145-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-145-30) ",
"NDC11Code": "31722-0145-30",
"ProductNDC": "31722-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214790",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red."
},
{
"NDCCode": "31722-145-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (31722-145-90) ",
"NDC11Code": "31722-0145-90",
"ProductNDC": "31722-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214790",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red."
},
{
"NDCCode": "33342-145-09",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (33342-145-09) ",
"NDC11Code": "33342-0145-09",
"ProductNDC": "33342-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204375",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170218",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone."
},
{
"NDCCode": "33342-145-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-145-12) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "33342-0145-12",
"ProductNDC": "33342-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204375",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170218",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone."
},
{
"NDCCode": "33342-145-51",
"PackageDescription": "300 CAPSULE in 1 BOTTLE (33342-145-51) ",
"NDC11Code": "33342-0145-51",
"ProductNDC": "33342-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204375",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170218",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone."
},
{
"NDCCode": "46708-360-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (46708-360-30) ",
"NDC11Code": "46708-0360-30",
"ProductNDC": "46708-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
},
{
"NDCCode": "46708-360-71",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (46708-360-71) ",
"NDC11Code": "46708-0360-71",
"ProductNDC": "46708-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
},
{
"NDCCode": "46708-360-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (46708-360-90) ",
"NDC11Code": "46708-0360-90",
"ProductNDC": "46708-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210476",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68196-145-80</NDCCode>
<PackageDescription>2360 mL in 1 BOTTLE, PLASTIC (68196-145-80)</PackageDescription>
<NDC11Code>68196-0145-80</NDC11Code>
<ProductNDC>68196-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Right Body Care</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121025</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83711-145-27</NDCCode>
<PackageDescription>80 g in 1 APPLICATOR (83711-145-27) </PackageDescription>
<NDC11Code>83711-0145-27</NDC11Code>
<ProductNDC>83711-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suave Men Extra Fresh Roll On Antiperspirant</ProprietaryName>
<NonProprietaryName>Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Suave Brands Co, LLC</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>17.6</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Reduces underarm wetness, 2 24 hour protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-140-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-140-80)</PackageDescription>
<NDC11Code>68196-0140-80</NDC11Code>
<ProductNDC>68196-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sp With Light Moisturizers</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-141-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-141-80)</PackageDescription>
<NDC11Code>68196-0141-80</NDC11Code>
<ProductNDC>68196-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sp With Light Moisturizers Refill</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-142-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-142-80)</PackageDescription>
<NDC11Code>68196-0142-80</NDC11Code>
<ProductNDC>68196-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<ProprietaryNameSuffix>Light Moisturizers</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-143-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-143-80)</PackageDescription>
<NDC11Code>68196-0143-80</NDC11Code>
<ProductNDC>68196-143</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<ProprietaryNameSuffix>Light Moisturizers Refill</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-144-80</NDCCode>
<PackageDescription>2360 mL in 1 BOTTLE, PLASTIC (68196-144-80)</PackageDescription>
<NDC11Code>68196-0144-80</NDC11Code>
<ProductNDC>68196-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Right Body Care</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121024</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-146-80</NDCCode>
<PackageDescription>2360 mL in 1 BOTTLE, PLASTIC (68196-146-80)</PackageDescription>
<NDC11Code>68196-0146-80</NDC11Code>
<ProductNDC>68196-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Right Body Care</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-147-80</NDCCode>
<PackageDescription>2360 mL in 1 BOTTLE, PLASTIC (68196-147-80)</PackageDescription>
<NDC11Code>68196-0147-80</NDC11Code>
<ProductNDC>68196-147</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Right Body Care</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>1.15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-149-80</NDCCode>
<PackageDescription>2365 mL in 1 PACKAGE (68196-149-80)</PackageDescription>
<NDC11Code>68196-0149-80</NDC11Code>
<ProductNDC>68196-149</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Right</ProprietaryName>
<ProprietaryNameSuffix>Hand</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HELPS ELIMINATE BACTERIA ON HANDS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-225-80</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (68196-225-80) > 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>68196-0225-80</NDC11Code>
<ProductNDC>68196-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206531</ApplicationNumber>
<LabelerName>Sam's West Inc</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68196-432-80</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (68196-432-80) > 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68196-0432-80</NDC11Code>
<ProductNDC>68196-432</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Members Mark Nasal Decongestant</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Sam's West Inc</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0002-9401-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-9401-01) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-9401-01</NDC11Code>
<ProductNDC>0002-9401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kisunla</ProprietaryName>
<NonProprietaryName>Donanemab-azbt</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240702</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761248</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DONANEMAB</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KISUNLATM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.</IndicationAndUsage>
<Description>Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta, and is expressed in a Chinese hamster ovary cell line. Donanemab-azbt has an approximate molecular weight of 145 kDa. KISUNLA (donanemab-azbt) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for intravenous infusion after dilution. KISUNLA is supplied in single-dose vials available in a concentration of 350 mg/20 mL (17.5 mg/mL). Each mL of solution contains 17.5 mg donanemab-azbt, anhydrous citric acid (0.32 mg), polysorbate 80 (0.20 mg), sodium citrate (2.15 mg), sucrose (80 mg), and Water for Injection, USP, at a pH of 5.5 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0069-0238-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00069-0238-01</NDC11Code>
<ProductNDC>0069-0238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ruxience</ProprietaryName>
<NonProprietaryName>Rituximab-pvvr</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761103</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
<Description>Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0069-0249-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00069-0249-01</NDC11Code>
<ProductNDC>0069-0249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ruxience</ProprietaryName>
<NonProprietaryName>Rituximab-pvvr</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761103</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
<Description>Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0143-9168-01</NDCCode>
<PackageDescription>.5 mL in 1 SYRINGE (0143-9168-01) </PackageDescription>
<NDC11Code>00143-9168-01</NDC11Code>
<ProductNDC>0143-9168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>0143-9169-01</NDCCode>
<PackageDescription>.5 mL in 1 VIAL (0143-9169-01) </PackageDescription>
<NDC11Code>00143-9169-01</NDC11Code>
<ProductNDC>0143-9169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>0143-9170-01</NDCCode>
<PackageDescription>1 mL in 1 SYRINGE (0143-9170-01) </PackageDescription>
<NDC11Code>00143-9170-01</NDC11Code>
<ProductNDC>0143-9170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>0143-9171-01</NDCCode>
<PackageDescription>26 mL in 1 VIAL (0143-9171-01) </PackageDescription>
<NDC11Code>00143-9171-01</NDC11Code>
<ProductNDC>0143-9171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Starjemza</ProprietaryName>
<NonProprietaryName>Ustekinumab-hmny</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251027</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761419</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/26mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>13310-145-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (13310-145-01) </PackageDescription>
<NDC11Code>13310-0145-01</NDC11Code>
<ProductNDC>13310-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bactrim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041101</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017377</ApplicationNumber>
<LabelerName>AR Scientific, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>400; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041101</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13310-145-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (13310-145-05) </PackageDescription>
<NDC11Code>13310-0145-05</NDC11Code>
<ProductNDC>13310-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bactrim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041101</StartMarketingDate>
<EndMarketingDate>20181228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017377</ApplicationNumber>
<LabelerName>AR Scientific, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>400; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041101</StartMarketingDatePackage>
<EndMarketingDatePackage>20181228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-145-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-145-05) </PackageDescription>
<NDC11Code>31722-0145-05</NDC11Code>
<ProductNDC>31722-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214790</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>31722-145-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-145-30) </PackageDescription>
<NDC11Code>31722-0145-30</NDC11Code>
<ProductNDC>31722-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214790</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>31722-145-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (31722-145-90) </PackageDescription>
<NDC11Code>31722-0145-90</NDC11Code>
<ProductNDC>31722-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214790</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>33342-145-09</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (33342-145-09) </PackageDescription>
<NDC11Code>33342-0145-09</NDC11Code>
<ProductNDC>33342-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204375</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone.</Description>
</NDC>
<NDC>
<NDCCode>33342-145-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-145-12) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0145-12</NDC11Code>
<ProductNDC>33342-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204375</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone.</Description>
</NDC>
<NDC>
<NDCCode>33342-145-51</NDCCode>
<PackageDescription>300 CAPSULE in 1 BOTTLE (33342-145-51) </PackageDescription>
<NDC11Code>33342-0145-51</NDC11Code>
<ProductNDC>33342-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204375</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, lactose monohydrate, polyethylene glycol, sodium starch glycolate, ammonium chloride, sucrose and sodium lauryl sulfate. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone.</Description>
</NDC>
<NDC>
<NDCCode>46708-360-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (46708-360-30) </PackageDescription>
<NDC11Code>46708-0360-30</NDC11Code>
<ProductNDC>46708-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>46708-360-71</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (46708-360-71) </PackageDescription>
<NDC11Code>46708-0360-71</NDC11Code>
<ProductNDC>46708-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>46708-360-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (46708-360-90) </PackageDescription>
<NDC11Code>46708-0360-90</NDC11Code>
<ProductNDC>46708-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210476</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:. · To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). · For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose, sodium lauryl sulfate, simethicone, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. In addition, individual tablet contains:. 48 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum, iron oxide yellow and iron oxide red. 145 mg tablets. Polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, titanium dioxide, talc, lecithin and xanthan gum. The USP Dissolution Test is pending.</Description>
</NDC>
</NDCList>