{
"NDC": [
{
"NDCCode": "63459-912-17",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (63459-912-17) / .8 mL in 1 SYRINGE, GLASS (63459-912-18) ",
"NDC11Code": "63459-0912-17",
"ProductNDC": "63459-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Granix",
"NonProprietaryName": "Tbo-filgrastim",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125294",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "480",
"StrengthUnit": "ug/.8mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.",
"Description": "GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation."
},
{
"NDCCode": "63459-910-17",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18) ",
"NDC11Code": "63459-0910-17",
"ProductNDC": "63459-910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Granix",
"NonProprietaryName": "Tbo-filgrastim",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125294",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "300",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.",
"Description": "GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation."
},
{
"NDCCode": "63459-912-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (63459-912-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) / .8 mL in 1 SYRINGE, GLASS (63459-912-01) ",
"NDC11Code": "63459-0912-11",
"ProductNDC": "63459-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Granix",
"NonProprietaryName": "Tbo-filgrastim",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125294",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "480",
"StrengthUnit": "ug/.8mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131111",
"SamplePackage": "N",
"IndicationAndUsage": "GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.",
"Description": "GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation."
},
{
"NDCCode": "63459-912-15",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (63459-912-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) / .8 mL in 1 SYRINGE, GLASS (63459-912-01) ",
"NDC11Code": "63459-0912-15",
"ProductNDC": "63459-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Granix",
"NonProprietaryName": "Tbo-filgrastim",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125294",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "480",
"StrengthUnit": "ug/.8mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131111",
"SamplePackage": "N",
"IndicationAndUsage": "GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.",
"Description": "GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation."
},
{
"NDCCode": "63459-912-36",
"PackageDescription": "5 SYRINGE, GLASS in 1 CARTON (63459-912-36) / .8 mL in 1 SYRINGE, GLASS (63459-912-18) ",
"NDC11Code": "63459-0912-36",
"ProductNDC": "63459-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Granix",
"NonProprietaryName": "Tbo-filgrastim",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125294",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "480",
"StrengthUnit": "ug/.8mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.",
"Description": "GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation."
},
{
"NDCCode": "51414-912-17",
"PackageDescription": "35 mL in 1 BOTTLE (51414-912-17) ",
"NDC11Code": "51414-0912-17",
"ProductNDC": "51414-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201010",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Yuyao Jessie Commodity Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201010",
"SamplePackage": "N",
"IndicationAndUsage": "for hand sanitizing."
},
{
"NDCCode": "63354-912-17",
"PackageDescription": "319 g in 1 BOTTLE (63354-912-17) ",
"NDC11Code": "63354-0912-17",
"ProductNDC": "63354-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hawaiian Tropic",
"NonProprietaryName": "Avobenzone,homosalate,octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Edgewell Personal Care Brands LLC",
"SubstanceName": "HOMOSALATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "7; 2.2; 4.2",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "66651-912-17",
"PackageDescription": "50 kg in 1 DRUM (66651-912-17) ",
"NDC11Code": "66651-0912-17",
"ProductNDC": "66651-912",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150818",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "HIKAL LIMITED",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-02-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "18-AUG-15"
},
{
"NDCCode": "84126-912-01",
"PackageDescription": "1 KIT in 1 KIT (84126-912-01) * 56.7 g in 1 TUBE (69423-556-57) * 170.1 g in 1 JAR (69423-556-17) ",
"NDC11Code": "84126-0912-01",
"ProductNDC": "84126-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Fab Ultra Repair Skin Protectant Kit",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to exzema rashes poison ivy, oak or sumac insect bites."
},
{
"NDCCode": "63459-103-10",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "63459-0103-10",
"ProductNDC": "63459-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Truxima",
"NonProprietaryName": "Rituximab-abbs",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200504",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761088",
"LabelerName": "Cephalon, Inc.",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200504",
"SamplePackage": "N",
"IndicationAndUsage": "TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: 1 Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously 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.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.",
"Description": "Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 kD. Rituximab-abbs is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. TRUXIMA 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-abbs, polysorbate 80 (0.7 mg), sodium chloride (9 mg), tri-sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. The pH is 6.5."
},
{
"NDCCode": "63459-104-50",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63459-104-50) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "63459-0104-50",
"ProductNDC": "63459-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Truxima",
"NonProprietaryName": "Rituximab-abbs",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200504",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761088",
"LabelerName": "Cephalon, Inc.",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200504",
"SamplePackage": "N",
"IndicationAndUsage": "TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: 1 Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously 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.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.",
"Description": "Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 kD. Rituximab-abbs is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. TRUXIMA 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-abbs, polysorbate 80 (0.7 mg), sodium chloride (9 mg), tri-sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. The pH is 6.5."
},
{
"NDCCode": "63459-600-10",
"PackageDescription": "10 AMPULE in 1 CARTON (63459-600-10) > 10 mL in 1 AMPULE (63459-600-01) ",
"NDC11Code": "63459-0600-10",
"ProductNDC": "63459-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trisenox",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20001015",
"EndMarketingDate": "20210815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021248",
"LabelerName": "Cephalon, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20001015",
"EndMarketingDatePackage": "20210815",
"SamplePackage": "N"
},
{
"NDCCode": "63459-601-06",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11) ",
"NDC11Code": "63459-0601-06",
"ProductNDC": "63459-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trisenox",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021248",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171222",
"SamplePackage": "N",
"IndicationAndUsage": "TRISENOX is an arsenical indicated: 1 In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.1), 2 For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2) .",
"Description": "TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. TRISENOX is available in 10 mL, single-dose vials containing 12 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 2 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8."
},
{
"NDCCode": "10544-912-99",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (10544-912-99) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "10544-0912-99",
"ProductNDC": "10544-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Hydrocortisone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20150521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064053",
"LabelerName": "Blenheim Pharmacal, Inc",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE",
"StrengthNumber": "3.5; 10000; 10",
"StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.",
"Description": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL Contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Hydrocortisone 10 mg (1%). INACTIVES: Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate, Glycerin, Purified Water. The pH range is 2.0 to 4.5. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are:. Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa, (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:. Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is. C 21H 30O 5 Mol. Wt. 362.47."
},
{
"NDCCode": "11071-912-01",
"PackageDescription": "42000 CAPSULE in 1 DRUM (11071-912-01) ",
"NDC11Code": "11071-0912-01",
"ProductNDC": "11071-912",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Lenvatinib",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eisai Co., Ltd.",
"SubstanceName": "LENVATINIB",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-08-17",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "13-FEB-15"
},
{
"NDCCode": "42291-912-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (42291-912-50) ",
"NDC11Code": "42291-0912-50",
"ProductNDC": "42291-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078071",
"LabelerName": "AvKARE",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210910",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) , 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone tablets, USP contains risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.48. The structural formula is:. Risperidone, USP is a white to almost white powder. Soluble in methylene dichloride, sparingly soluble in alcohol It is practically insoluble in water. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Risperidone tablets contain the following inactive ingredients: lactose anhydrous, NF, microcrystalline cellulose, NF, magnesium stearate, NF, and pregelatinized starch, NF. Tablets of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg also contain hypromellose and macrogol. The 0.25 mg tablets contain D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Ferrosoferric Oxide, Iron Oxide Yellow and Titanium Dioxide; 0.5 mg tablets contain Iron Oxide Red and Titanium Dioxide; 2 mg tablets contain FD&C Yellow #6 Aluminum Lake and Titanium Dioxide; the 3 mg and 4 mg tablets contain FD&C Yellow #5 Aluminum Lake and Titanium Dioxide; the 3 mg tablets contain FD&C Blue #2 Aluminum Lake and the 4 mg tablets contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "42385-930-72",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42385-930-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-930-17) ",
"NDC11Code": "42385-0930-72",
"ProductNDC": "42385-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213676",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "42385-931-72",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42385-931-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17) ",
"NDC11Code": "42385-0931-72",
"ProductNDC": "42385-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213676",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "42385-932-72",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42385-932-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-932-17) ",
"NDC11Code": "42385-0932-72",
"ProductNDC": "42385-932",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213676",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "52125-912-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-912-02)",
"NDC11Code": "52125-0912-02",
"ProductNDC": "52125-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trihexyphenidyl Hydrochloride",
"NonProprietaryName": "Trihexyphenidyl Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040254",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TRIHEXYPHENIDYL HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65162-912-48",
"PackageDescription": "10 CUP, UNIT-DOSE in 1 TRAY (65162-912-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-912-43) ",
"NDC11Code": "65162-0912-48",
"ProductNDC": "65162-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204839",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240329",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "65162-912-52",
"PackageDescription": "200 mL in 1 BOTTLE (65162-912-52) ",
"NDC11Code": "65162-0912-52",
"ProductNDC": "65162-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204839",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240329",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "67457-912-01",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67457-912-01) / 3 mL in 1 VIAL, GLASS (67457-912-00) ",
"NDC11Code": "67457-0912-01",
"ProductNDC": "67457-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultiva",
"NonProprietaryName": "Remifentanil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020630",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "REMIFENTANIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200415",
"SamplePackage": "N",
"IndicationAndUsage": "ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.",
"Description": "ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3."
},
{
"NDCCode": "69842-912-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (69842-912-30) / 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "69842-0912-30",
"ProductNDC": "69842-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Childrens",
"ProprietaryNameSuffix": "Saline Laxative",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190516",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS PHARMACY,INC.",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190516",
"SamplePackage": "N",
"IndicationAndUsage": "▪for relief of occasional constipation. ▪this product usually produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "71205-912-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (71205-912-00) ",
"NDC11Code": "71205-0912-00",
"ProductNDC": "71205-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211364",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210716",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.</IndicationAndUsage>
<Description>GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation.</Description>
</NDC>
<NDC>
<NDCCode>63459-912-15</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (63459-912-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) / .8 mL in 1 SYRINGE, GLASS (63459-912-01) </PackageDescription>
<NDC11Code>63459-0912-15</NDC11Code>
<ProductNDC>63459-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Granix</ProprietaryName>
<NonProprietaryName>Tbo-filgrastim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131111</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125294</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FILGRASTIM</SubstanceName>
<StrengthNumber>480</StrengthNumber>
<StrengthUnit>ug/.8mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.</IndicationAndUsage>
<Description>GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation.</Description>
</NDC>
<NDC>
<NDCCode>63459-912-36</NDCCode>
<PackageDescription>5 SYRINGE, GLASS in 1 CARTON (63459-912-36) / .8 mL in 1 SYRINGE, GLASS (63459-912-18) </PackageDescription>
<NDC11Code>63459-0912-36</NDC11Code>
<ProductNDC>63459-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Granix</ProprietaryName>
<NonProprietaryName>Tbo-filgrastim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131111</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125294</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FILGRASTIM</SubstanceName>
<StrengthNumber>480</StrengthNumber>
<StrengthUnit>ug/.8mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.</IndicationAndUsage>
<Description>GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation.</Description>
</NDC>
<NDC>
<NDCCode>51414-912-17</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE (51414-912-17) </PackageDescription>
<NDC11Code>51414-0912-17</NDC11Code>
<ProductNDC>51414-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201010</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Yuyao Jessie Commodity Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand sanitizing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63354-912-17</NDCCode>
<PackageDescription>319 g in 1 BOTTLE (63354-912-17) </PackageDescription>
<NDC11Code>63354-0912-17</NDC11Code>
<ProductNDC>63354-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hawaiian Tropic</ProprietaryName>
<NonProprietaryName>Avobenzone,homosalate,octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Edgewell Personal Care Brands LLC</LabelerName>
<SubstanceName>HOMOSALATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7; 2.2; 4.2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66651-912-17</NDCCode>
<PackageDescription>50 kg in 1 DRUM (66651-912-17) </PackageDescription>
<NDC11Code>66651-0912-17</NDC11Code>
<ProductNDC>66651-912</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150818</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>HIKAL LIMITED</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-02-23</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-AUG-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84126-912-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (84126-912-01) * 56.7 g in 1 TUBE (69423-556-57) * 170.1 g in 1 JAR (69423-556-17) </PackageDescription>
<NDC11Code>84126-0912-01</NDC11Code>
<ProductNDC>84126-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Beauty Fab Ultra Repair Skin Protectant Kit</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to exzema rashes poison ivy, oak or sumac insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63459-103-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>63459-0103-10</NDC11Code>
<ProductNDC>63459-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Truxima</ProprietaryName>
<NonProprietaryName>Rituximab-abbs</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200504</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761088</ApplicationNumber>
<LabelerName>Cephalon, Inc.</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: 1 Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously 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.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.</IndicationAndUsage>
<Description>Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 kD. Rituximab-abbs is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. TRUXIMA 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-abbs, polysorbate 80 (0.7 mg), sodium chloride (9 mg), tri-sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. The pH is 6.5.</Description>
</NDC>
<NDC>
<NDCCode>63459-104-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (63459-104-50) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>63459-0104-50</NDC11Code>
<ProductNDC>63459-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Truxima</ProprietaryName>
<NonProprietaryName>Rituximab-abbs</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200504</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761088</ApplicationNumber>
<LabelerName>Cephalon, Inc.</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: 1 Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously 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.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.</IndicationAndUsage>
<Description>Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 kD. Rituximab-abbs is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. TRUXIMA 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-abbs, polysorbate 80 (0.7 mg), sodium chloride (9 mg), tri-sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. The pH is 6.5.</Description>
</NDC>
<NDC>
<NDCCode>63459-600-10</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (63459-600-10) > 10 mL in 1 AMPULE (63459-600-01) </PackageDescription>
<NDC11Code>63459-0600-10</NDC11Code>
<ProductNDC>63459-600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trisenox</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20001015</StartMarketingDate>
<EndMarketingDate>20210815</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021248</ApplicationNumber>
<LabelerName>Cephalon, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20001015</StartMarketingDatePackage>
<EndMarketingDatePackage>20210815</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63459-601-06</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11) </PackageDescription>
<NDC11Code>63459-0601-06</NDC11Code>
<ProductNDC>63459-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trisenox</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021248</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRISENOX is an arsenical indicated: 1 In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.1), 2 For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2) .</IndicationAndUsage>
<Description>TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. TRISENOX is available in 10 mL, single-dose vials containing 12 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 2 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8.</Description>
</NDC>
<NDC>
<NDCCode>10544-912-99</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (10544-912-99) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>10544-0912-99</NDC11Code>
<ProductNDC>10544-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Hydrocortisone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20150521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064053</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE</SubstanceName>
<StrengthNumber>3.5; 10000; 10</StrengthNumber>
<StrengthUnit>mg/mL; [USP'U]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.</IndicationAndUsage>
<Description>Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL Contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Hydrocortisone 10 mg (1%). INACTIVES: Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate, Glycerin, Purified Water. The pH range is 2.0 to 4.5. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are:. Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa, (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:. Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is. C 21H 30O 5 Mol. Wt. 362.47.</Description>
</NDC>
<NDC>
<NDCCode>11071-912-01</NDCCode>
<PackageDescription>42000 CAPSULE in 1 DRUM (11071-912-01) </PackageDescription>
<NDC11Code>11071-0912-01</NDC11Code>
<ProductNDC>11071-912</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Lenvatinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20150213</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eisai Co., Ltd.</LabelerName>
<SubstanceName>LENVATINIB</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-08-17</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-FEB-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>42291-912-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42291-912-50) </PackageDescription>
<NDC11Code>42291-0912-50</NDC11Code>
<ProductNDC>42291-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078071</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) , 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone tablets, USP contains risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.48. The structural formula is:. Risperidone, USP is a white to almost white powder. Soluble in methylene dichloride, sparingly soluble in alcohol It is practically insoluble in water. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Risperidone tablets contain the following inactive ingredients: lactose anhydrous, NF, microcrystalline cellulose, NF, magnesium stearate, NF, and pregelatinized starch, NF. Tablets of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg also contain hypromellose and macrogol. The 0.25 mg tablets contain D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Ferrosoferric Oxide, Iron Oxide Yellow and Titanium Dioxide; 0.5 mg tablets contain Iron Oxide Red and Titanium Dioxide; 2 mg tablets contain FD&C Yellow #6 Aluminum Lake and Titanium Dioxide; the 3 mg and 4 mg tablets contain FD&C Yellow #5 Aluminum Lake and Titanium Dioxide; the 3 mg tablets contain FD&C Blue #2 Aluminum Lake and the 4 mg tablets contain FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42385-930-72</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (42385-930-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-930-17) </PackageDescription>
<NDC11Code>42385-0930-72</NDC11Code>
<ProductNDC>42385-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213676</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>42385-931-72</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (42385-931-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17) </PackageDescription>
<NDC11Code>42385-0931-72</NDC11Code>
<ProductNDC>42385-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213676</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>42385-932-72</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (42385-932-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-932-17) </PackageDescription>
<NDC11Code>42385-0932-72</NDC11Code>
<ProductNDC>42385-932</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213676</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>52125-912-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-912-02)</PackageDescription>
<NDC11Code>52125-0912-02</NDC11Code>
<ProductNDC>52125-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trihexyphenidyl Hydrochloride</ProprietaryName>
<NonProprietaryName>Trihexyphenidyl Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040254</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TRIHEXYPHENIDYL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65162-912-48</NDCCode>
<PackageDescription>10 CUP, UNIT-DOSE in 1 TRAY (65162-912-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-912-43) </PackageDescription>
<NDC11Code>65162-0912-48</NDC11Code>
<ProductNDC>65162-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204839</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>65162-912-52</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (65162-912-52) </PackageDescription>
<NDC11Code>65162-0912-52</NDC11Code>
<ProductNDC>65162-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204839</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>67457-912-01</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67457-912-01) / 3 mL in 1 VIAL, GLASS (67457-912-00) </PackageDescription>
<NDC11Code>67457-0912-01</NDC11Code>
<ProductNDC>67457-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultiva</ProprietaryName>
<NonProprietaryName>Remifentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020630</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>REMIFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.</IndicationAndUsage>
<Description>ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3.</Description>
</NDC>
<NDC>
<NDCCode>69842-912-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69842-912-30) / 30 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0912-30</NDC11Code>
<ProductNDC>69842-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Childrens</ProprietaryName>
<ProprietaryNameSuffix>Saline Laxative</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS PHARMACY,INC.</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>▪for relief of occasional constipation. ▪this product usually produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-912-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (71205-912-00) </PackageDescription>
<NDC11Code>71205-0912-00</NDC11Code>
<ProductNDC>71205-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211364</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
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<Description>Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro‑ 5H-dibenz [b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients. D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide.</Description>
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<IndicationAndUsage>Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro‑ 5H-dibenz [b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients. D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide.</Description>
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<IndicationAndUsage>Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro‑ 5H-dibenz [b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients. D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide.</Description>
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<IndicationAndUsage>Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro‑ 5H-dibenz [b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients. D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide.</Description>
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<IndicationAndUsage>Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro‑ 5H-dibenz [b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients. D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide.</Description>
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