{
"NDC": [
{
"NDCCode": "70377-011-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-011-23) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0011-23",
"ProductNDC": "70377-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240517",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-011-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (70377-011-11) ",
"NDC11Code": "70377-0011-11",
"ProductNDC": "70377-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230608",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-011-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-011-22) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0011-22",
"ProductNDC": "70377-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-010-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-010-23) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0010-23",
"ProductNDC": "70377-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240517",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-012-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-012-23) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0012-23",
"ProductNDC": "70377-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240517",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-013-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-013-23) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0013-23",
"ProductNDC": "70377-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240517",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-090-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-090-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "70377-0090-23",
"ProductNDC": "70377-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217216",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
},
{
"NDCCode": "70377-091-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-091-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "70377-0091-23",
"ProductNDC": "70377-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217216",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
},
{
"NDCCode": "70377-092-23",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-092-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "70377-0092-23",
"ProductNDC": "70377-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217216",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
},
{
"NDCCode": "42659-011-23",
"PackageDescription": "500 mL in 1 BOTTLE (42659-011-23)",
"NDC11Code": "42659-0011-23",
"ProductNDC": "42659-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plum Emergency Eyewash/eyewash Duo/eyewash Shower Iss Usa",
"NonProprietaryName": "Water",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Plum A/S",
"SubstanceName": "WATER",
"StrengthNumber": "99.1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination."
},
{
"NDCCode": "44397-011-23",
"PackageDescription": "10450 L in 1 CYLINDER (44397-011-23)",
"NDC11Code": "44397-0011-23",
"ProductNDC": "44397-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19740101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205891",
"LabelerName": "Argyle Welding Supply Company, Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52086-011-23",
"PackageDescription": "849 L in 1 CYLINDER (52086-011-23) ",
"NDC11Code": "52086-0011-23",
"ProductNDC": "52086-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19830908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205889",
"LabelerName": "Helget Gas Products",
"SubstanceName": "OXYGEN",
"StrengthNumber": "999",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830908",
"SamplePackage": "N"
},
{
"NDCCode": "52862-011-23",
"PackageDescription": "368 g in 1 BOTTLE (52862-011-23) ",
"NDC11Code": "52862-0011-23",
"ProductNDC": "52862-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Health Smart Lavender Baby Petroleum",
"NonProprietaryName": "White Petroleum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130728",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Home Smart Products",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "99.9",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130728",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Temporarily protects minor cuts, scrapes or burns., 2 Temporarily protects and helps relieve chapped or cracked skin and lips., 3 Helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "69013-011-01",
"PackageDescription": "23 g in 1 PACKAGE (69013-011-01)",
"NDC11Code": "69013-0011-01",
"ProductNDC": "69013-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elishacoy Skin Refining Snail Mask",
"NonProprietaryName": "Glycerin",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170930",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Elishacoy Co., Inc",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "8",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "72922-011-23",
"PackageDescription": "240 mL in 1 BOTTLE (72922-011-23) ",
"NDC11Code": "72922-0011-23",
"ProductNDC": "72922-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ShangRao chunyu Technology CO.,LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "74761-011-23",
"PackageDescription": "75 mL in 1 BOTTLE (74761-011-23) ",
"NDC11Code": "74761-0011-23",
"ProductNDC": "74761-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sanitizer",
"NonProprietaryName": "Antibacterial Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200419",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Oumiao Cosmetics Co. Ltd. ",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200419",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on skin."
},
{
"NDCCode": "70377-089-01",
"PackageDescription": "50 PACKET in 1 CARTON (70377-089-01) > 10 mL in 1 PACKET",
"NDC11Code": "70377-0089-01",
"ProductNDC": "70377-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vigabatrin",
"NonProprietaryName": "Vigabatrin",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213390",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "VIGABATRIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220829",
"SamplePackage": "N",
"Description": "Vigabatrin, USP is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C6H11NO2 and the molecular weight is 129.16. It has the following structural formula. Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution, USP is available as white to off white granular powder for oral administration. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone."
},
{
"NDCCode": "70377-010-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (70377-010-11) ",
"NDC11Code": "70377-0010-11",
"ProductNDC": "70377-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230608",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-010-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-010-22) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0010-22",
"ProductNDC": "70377-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-012-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (70377-012-11) ",
"NDC11Code": "70377-0012-11",
"ProductNDC": "70377-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230608",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-012-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-012-22) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0012-22",
"ProductNDC": "70377-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-013-11",
"PackageDescription": "30 TABLET in 1 BOTTLE (70377-013-11) ",
"NDC11Code": "70377-0013-11",
"ProductNDC": "70377-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230608",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-013-22",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70377-013-22) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0013-22",
"ProductNDC": "70377-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).",
"Description": "Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "70377-069-11",
"PackageDescription": "60 TABLET in 1 BOTTLE (70377-069-11) ",
"NDC11Code": "70377-0069-11",
"ProductNDC": "70377-069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216140",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
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"PackageDescription": "6 BLISTER PACK in 1 CARTON (70377-069-12) / 10 TABLET in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
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"LabelerName": "Biocon Pharma Inc.",
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"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
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"PackageDescription": "60 TABLET in 1 BOTTLE (70377-070-11) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"StartMarketingDate": "20250602",
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"LabelerName": "Biocon Pharma Inc.",
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"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"LastUpdate": "2025-06-02",
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"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "70377-070-21",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (70377-070-21) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "70377-0070-21",
"ProductNDC": "70377-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216140",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "70377-071-11",
"PackageDescription": "60 TABLET in 1 BOTTLE (70377-071-11) ",
"NDC11Code": "70377-0071-11",
"ProductNDC": "70377-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216140",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".75",
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"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
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"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "70377-071-12",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (70377-071-12) / 10 TABLET in 1 BLISTER PACK",
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"ProductNDC": "70377-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
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"RouteName": "ORAL",
"StartMarketingDate": "20250602",
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"ApplicationNumber": "ANDA216140",
"LabelerName": "Biocon Pharma Inc.",
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"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
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"IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "70377-090-11",
"PackageDescription": "28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-090-11) ",
"NDC11Code": "70377-0090-11",
"ProductNDC": "70377-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217216",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "EVEROLIMUS",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
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"StartMarketingDatePackage": "20260114",
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"IndicationAndUsage": "Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose."
}
]
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<LabelerName>Biocon Pharma Inc.</LabelerName>
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<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<LabelerName>Biocon Pharma Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
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<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (70377-090-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK</PackageDescription>
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<LabelerName>Biocon Pharma Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
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<ProductNDC>70377-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217216</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
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<NonProprietaryName>Everolimus</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
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<IndicationAndUsage>For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination.</IndicationAndUsage>
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<LastUpdate>2019-09-21</LastUpdate>
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<LabelerName>Helget Gas Products</LabelerName>
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<LastUpdate>2025-12-23</LastUpdate>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Uses: 1 Temporarily protects minor cuts, scrapes or burns., 2 Temporarily protects and helps relieve chapped or cracked skin and lips., 3 Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
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<NDC>
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<LastUpdate>2019-10-18</LastUpdate>
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<NDC>
<NDCCode>72922-011-23</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE (72922-011-23) </PackageDescription>
<NDC11Code>72922-0011-23</NDC11Code>
<ProductNDC>72922-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ShangRao chunyu Technology CO.,LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74761-011-23</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (74761-011-23) </PackageDescription>
<NDC11Code>74761-0011-23</NDC11Code>
<ProductNDC>74761-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Antibacterial Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Oumiao Cosmetics Co. Ltd. </LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70377-089-01</NDCCode>
<PackageDescription>50 PACKET in 1 CARTON (70377-089-01) > 10 mL in 1 PACKET</PackageDescription>
<NDC11Code>70377-0089-01</NDC11Code>
<ProductNDC>70377-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vigabatrin</ProprietaryName>
<NonProprietaryName>Vigabatrin</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213390</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>VIGABATRIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vigabatrin, USP is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C6H11NO2 and the molecular weight is 129.16. It has the following structural formula. Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution, USP is available as white to off white granular powder for oral administration. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone.</Description>
</NDC>
<NDC>
<NDCCode>70377-010-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70377-010-11) </PackageDescription>
<NDC11Code>70377-0010-11</NDC11Code>
<ProductNDC>70377-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-010-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (70377-010-22) / 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0010-22</NDC11Code>
<ProductNDC>70377-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-012-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70377-012-11) </PackageDescription>
<NDC11Code>70377-0012-11</NDC11Code>
<ProductNDC>70377-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-012-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (70377-012-22) / 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0012-22</NDC11Code>
<ProductNDC>70377-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-013-11</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70377-013-11) </PackageDescription>
<NDC11Code>70377-0013-11</NDC11Code>
<ProductNDC>70377-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-013-22</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (70377-013-22) / 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0013-22</NDC11Code>
<ProductNDC>70377-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
<Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70377-069-11</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (70377-069-11) </PackageDescription>
<NDC11Code>70377-0069-11</NDC11Code>
<ProductNDC>70377-069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216140</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<PackageDescription>6 BLISTER PACK in 1 CARTON (70377-069-12) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
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<LabelerName>Biocon Pharma Inc.</LabelerName>
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<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<PackageDescription>60 TABLET in 1 BOTTLE (70377-070-11) </PackageDescription>
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<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
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<ApplicationNumber>ANDA216140</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2025-06-02</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<NDCCode>70377-070-21</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (70377-070-21) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0070-21</NDC11Code>
<ProductNDC>70377-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216140</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<NDCCode>70377-071-11</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (70377-071-11) </PackageDescription>
<NDC11Code>70377-0071-11</NDC11Code>
<ProductNDC>70377-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216140</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>70377-071-12</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (70377-071-12) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0071-12</NDC11Code>
<ProductNDC>70377-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216140</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients. Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following. Kidney transplant patients at high immunologic risk (1.3). Recipients of transplanted organs other than kidney or liver (1.3, 5.7). Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus tablets are a macrolide immunosuppressant. The chemical name of everolimus USP is. (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2R)-1- [(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30 dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.24 g/mol. The structural formula is. Everolimus tablets are supplied for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus USP together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate and poloxamer 188 as inactive ingredients. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<NDCCode>70377-090-11</NDCCode>
<PackageDescription>28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-090-11) </PackageDescription>
<NDC11Code>70377-0090-11</NDC11Code>
<ProductNDC>70377-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217216</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are kinase inhibitor. The chemical name of everolimus USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg or 5 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
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