{
"NDC": [
{
"NDCCode": "73362-016-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-016-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-016-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0016-01",
"ProductNDC": "73362-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-003-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-003-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-003-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0003-01",
"ProductNDC": "73362-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-004-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-004-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-004-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0004-01",
"ProductNDC": "73362-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "3.6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-005-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-005-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-005-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0005-01",
"ProductNDC": "73362-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-006-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-006-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-006-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0006-01",
"ProductNDC": "73362-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-007-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-007-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-007-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0007-01",
"ProductNDC": "73362-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "6.3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-008-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-008-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-008-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0008-01",
"ProductNDC": "73362-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-009-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-009-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-009-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0009-01",
"ProductNDC": "73362-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-010-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-010-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-010-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0010-01",
"ProductNDC": "73362-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-011-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-011-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-011-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
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"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
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"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-012-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-012-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-012-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0012-01",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
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"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
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"SubstanceName": "LONAPEGSOMATROPIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-013-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-013-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-013-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0013-01",
"ProductNDC": "73362-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-014-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-014-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-014-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0014-01",
"ProductNDC": "73362-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "1.8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-015-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-015-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-015-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0015-01",
"ProductNDC": "73362-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "2.1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "73362-100-01",
"PackageDescription": "2 BOX in 1 CARTON (73362-100-01) / 1 SYRINGE in 1 BOX (73362-100-02) / 1 CARTRIDGE in 1 SYRINGE (73362-100-03) / .56 mL in 1 CARTRIDGE",
"NDC11Code": "73362-0100-01",
"ProductNDC": "73362-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yorvipath",
"NonProprietaryName": "Palopegteriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216490",
"LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
"SubstanceName": "PALOPEGTERIPARATIDE",
"StrengthNumber": "168",
"StrengthUnit": "ug/.56mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240809",
"SamplePackage": "N",
"IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
"Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
},
{
"NDCCode": "73362-101-01",
"PackageDescription": "2 BOX in 1 CARTON (73362-101-01) / 1 SYRINGE in 1 BOX (73362-101-02) / 1 CARTRIDGE in 1 SYRINGE (73362-101-03) / .98 mL in 1 CARTRIDGE",
"NDC11Code": "73362-0101-01",
"ProductNDC": "73362-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yorvipath",
"NonProprietaryName": "Palopegteriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216490",
"LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
"SubstanceName": "PALOPEGTERIPARATIDE",
"StrengthNumber": "294",
"StrengthUnit": "ug/.98mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240809",
"SamplePackage": "N",
"IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
"Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
},
{
"NDCCode": "73362-102-01",
"PackageDescription": "2 BOX in 1 CARTON (73362-102-01) / 1 SYRINGE in 1 BOX (73362-102-02) / 1 CARTRIDGE in 1 SYRINGE (73362-102-03) / 1.4 mL in 1 CARTRIDGE",
"NDC11Code": "73362-0102-01",
"ProductNDC": "73362-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yorvipath",
"NonProprietaryName": "Palopegteriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216490",
"LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
"SubstanceName": "PALOPEGTERIPARATIDE",
"StrengthNumber": "420",
"StrengthUnit": "ug/1.4mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240809",
"SamplePackage": "N",
"IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
"Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
},
{
"NDCCode": "73362-201-01",
"PackageDescription": "4 BOX in 1 CARTON (73362-201-01) / 1 KIT in 1 BOX (73362-201-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-205-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) ",
"NDC11Code": "73362-0201-01",
"ProductNDC": "73362-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yuviwel",
"NonProprietaryName": "Navepegritide",
"DosageFormName": "KIT",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219164",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3."
},
{
"NDCCode": "73362-202-01",
"PackageDescription": "4 BOX in 1 CARTON (73362-202-01) / 1 KIT in 1 BOX (73362-202-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-206-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) ",
"NDC11Code": "73362-0202-01",
"ProductNDC": "73362-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yuviwel",
"NonProprietaryName": "Navepegritide",
"DosageFormName": "KIT",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219164",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3."
},
{
"NDCCode": "73362-203-01",
"PackageDescription": "4 BOX in 1 CARTON (73362-203-01) / 1 KIT in 1 BOX (73362-203-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-207-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) ",
"NDC11Code": "73362-0203-01",
"ProductNDC": "73362-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yuviwel",
"NonProprietaryName": "Navepegritide",
"DosageFormName": "KIT",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219164",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3."
},
{
"NDCCode": "10348-016-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-016-01) > 30 mL in 1 TUBE",
"NDC11Code": "10348-0016-01",
"ProductNDC": "10348-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Photo Finish Foundation Primer Broad Spectrum Sp 20 With Dermaxyl Complex",
"NonProprietaryName": "Avobenzone, Homosalate, And Octisalate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": ".019; .1425; .0475",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120527",
"SamplePackage": "N"
},
{
"NDCCode": "10702-016-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) ",
"NDC11Code": "10702-0016-01",
"ProductNDC": "10702-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079175",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090306",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16CINO 4, and it has the following chemical structure. Indomethacin is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Extended-Release Capsules, 75 mg include. corn starch, D&C Yellow # 10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "11994-016-01",
"PackageDescription": "3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01) ",
"NDC11Code": "11994-0016-01",
"ProductNDC": "11994-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quadramet",
"NonProprietaryName": "Samarium Sm 153 Lexidronam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020570",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "SAMARIUM SM-153 LEXIDRONAM PENTASODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mCi/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19970519",
"SamplePackage": "N"
},
{
"NDCCode": "13733-016-01",
"PackageDescription": "25 g in 1 CARTON (13733-016-01)",
"NDC11Code": "13733-0016-01",
"ProductNDC": "13733-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Glam Silky Body Balm",
"ProprietaryNameSuffix": "Spf 27",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "1.88; 1.5; .48",
"StrengthUnit": "g/25g; g/25g; g/25g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE: Apply as desired with encased puff."
},
{
"NDCCode": "14141-016-01",
"PackageDescription": "1 CASE in 1 BOX (14141-016-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0016-01",
"ProductNDC": "14141-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 330-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-016-01",
"PackageDescription": "5 kg in 1 DRUM (14445-016-01) ",
"NDC11Code": "14445-0016-01",
"ProductNDC": "14445-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alogliptin Benzoate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALOGLIPTIN BENZOATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-JUN-16"
},
{
"NDCCode": "14783-016-01",
"PackageDescription": "1 g in 1 PACKET (14783-016-01)",
"NDC11Code": "14783-0016-01",
"ProductNDC": "14783-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 45plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against Noticeable Signs Of Aging Day - Oily Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-016-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (16714-016-10) / .4 mL in 1 SYRINGE (16714-016-01) ",
"NDC11Code": "16714-0016-10",
"ProductNDC": "16714-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206834",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .",
"Description": "Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "17714-016-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (17714-016-01)",
"NDC11Code": "17714-0016-01",
"ProductNDC": "17714-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Allergy",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Advance Pharmaceutical Inc.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020109",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies : 1 runny nose, 2 itchy nose or throat, 3 sneezing, 4 itchy, watery eyes."
},
{
"NDCCode": "18124-016-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (18124-016-01) > 1.1 mL in 1 SYRINGE",
"NDC11Code": "18124-0016-01",
"ProductNDC": "18124-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Hydroxyprogesterone Caproate",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20110203",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Fresenius Kabi Austria GmbH",
"SubstanceName": "HYDROXYPROGESTERONE CAPROATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2022-11-15",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "03-FEB-11"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>73362-016-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-016-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-016-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0016-01</NDC11Code>
<ProductNDC>73362-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skytrofa</ProprietaryName>
<NonProprietaryName>Lonapegsomatropin-tcgd</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761177</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<SubstanceName>LONAPEGSOMATROPIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>73362-013-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-013-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-013-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0013-01</NDC11Code>
<ProductNDC>73362-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761177</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<SubstanceName>LONAPEGSOMATROPIN</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
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<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>73362-014-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-014-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-014-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
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<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
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<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>73362-015-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-015-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-015-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0015-01</NDC11Code>
<ProductNDC>73362-015</ProductNDC>
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<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761177</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<SubstanceName>LONAPEGSOMATROPIN</SubstanceName>
<StrengthNumber>2.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>73362-100-01</NDCCode>
<PackageDescription>2 BOX in 1 CARTON (73362-100-01) / 1 SYRINGE in 1 BOX (73362-100-02) / 1 CARTRIDGE in 1 SYRINGE (73362-100-03) / .56 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0100-01</NDC11Code>
<ProductNDC>73362-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yorvipath</ProprietaryName>
<NonProprietaryName>Palopegteriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240809</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216490</ApplicationNumber>
<LabelerName>Ascendis Pharma, Endocrinology, Inc.</LabelerName>
<SubstanceName>PALOPEGTERIPARATIDE</SubstanceName>
<StrengthNumber>168</StrengthNumber>
<StrengthUnit>ug/.56mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.</IndicationAndUsage>
<Description>YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide.</Description>
</NDC>
<NDC>
<NDCCode>73362-101-01</NDCCode>
<PackageDescription>2 BOX in 1 CARTON (73362-101-01) / 1 SYRINGE in 1 BOX (73362-101-02) / 1 CARTRIDGE in 1 SYRINGE (73362-101-03) / .98 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0101-01</NDC11Code>
<ProductNDC>73362-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yorvipath</ProprietaryName>
<NonProprietaryName>Palopegteriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240809</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216490</ApplicationNumber>
<LabelerName>Ascendis Pharma, Endocrinology, Inc.</LabelerName>
<SubstanceName>PALOPEGTERIPARATIDE</SubstanceName>
<StrengthNumber>294</StrengthNumber>
<StrengthUnit>ug/.98mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.</IndicationAndUsage>
<Description>YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide.</Description>
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<PackageDescription>2 BOX in 1 CARTON (73362-102-01) / 1 SYRINGE in 1 BOX (73362-102-02) / 1 CARTRIDGE in 1 SYRINGE (73362-102-03) / 1.4 mL in 1 CARTRIDGE</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yorvipath</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240809</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216490</ApplicationNumber>
<LabelerName>Ascendis Pharma, Endocrinology, Inc.</LabelerName>
<SubstanceName>PALOPEGTERIPARATIDE</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>ug/1.4mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.</IndicationAndUsage>
<Description>YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide.</Description>
</NDC>
<NDC>
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<PackageDescription>4 BOX in 1 CARTON (73362-201-01) / 1 KIT in 1 BOX (73362-201-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-205-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) </PackageDescription>
<NDC11Code>73362-0201-01</NDC11Code>
<ProductNDC>73362-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yuviwel</ProprietaryName>
<NonProprietaryName>Navepegritide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219164</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3.</Description>
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<NDC11Code>73362-0202-01</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yuviwel</ProprietaryName>
<NonProprietaryName>Navepegritide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219164</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3.</Description>
</NDC>
<NDC>
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<PackageDescription>4 BOX in 1 CARTON (73362-203-01) / 1 KIT in 1 BOX (73362-203-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-207-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) </PackageDescription>
<NDC11Code>73362-0203-01</NDC11Code>
<ProductNDC>73362-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yuviwel</ProprietaryName>
<NonProprietaryName>Navepegritide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219164</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>YUVIWEL® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows:. The molecular formula is C231H386N64O67S5 + 4 × (C2H4O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3.</Description>
</NDC>
<NDC>
<NDCCode>10348-016-01</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Photo Finish Foundation Primer Broad Spectrum Sp 20 With Dermaxyl Complex</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, And Octisalate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>.019; .1425; .0475</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>10702-016-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) </PackageDescription>
<NDC11Code>10702-0016-01</NDC11Code>
<ProductNDC>10702-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079175</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16CINO 4, and it has the following chemical structure. Indomethacin is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Extended-Release Capsules, 75 mg include. corn starch, D&C Yellow # 10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. This product meets USP Drug Release Test 2 Specifications.</Description>
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<NDC>
<NDCCode>11994-016-01</NDCCode>
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<ProductNDC>11994-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quadramet</ProprietaryName>
<NonProprietaryName>Samarium Sm 153 Lexidronam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020570</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>SAMARIUM SM-153 LEXIDRONAM PENTASODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<NDC11Code>13733-0016-01</NDC11Code>
<ProductNDC>13733-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha Glam Silky Body Balm</ProprietaryName>
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<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.88; 1.5; .48</StrengthNumber>
<StrengthUnit>g/25g; g/25g; g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE: Apply as desired with encased puff.</IndicationAndUsage>
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<ProductNDC>14141-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 330-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>14445-0016-01</NDC11Code>
<ProductNDC>14445-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alogliptin Benzoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUN-16</StartMarketingDatePackage>
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<NDC>
<NDCCode>14783-016-01</NDCCode>
<PackageDescription>1 g in 1 PACKET (14783-016-01)</PackageDescription>
<NDC11Code>14783-0016-01</NDC11Code>
<ProductNDC>14783-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 45plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against Noticeable Signs Of Aging Day - Oily Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<PackageDescription>10 SYRINGE in 1 CARTON (16714-016-10) / .4 mL in 1 SYRINGE (16714-016-01) </PackageDescription>
<NDC11Code>16714-0016-10</NDC11Code>
<ProductNDC>16714-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206834</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>17714-016-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (17714-016-01)</PackageDescription>
<NDC11Code>17714-0016-01</NDC11Code>
<ProductNDC>17714-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Allergy</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Advance Pharmaceutical Inc.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies : 1 runny nose, 2 itchy nose or throat, 3 sneezing, 4 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>18124-016-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (18124-016-01) > 1.1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>18124-0016-01</NDC11Code>
<ProductNDC>18124-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Hydroxyprogesterone Caproate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20110203</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Fresenius Kabi Austria GmbH</LabelerName>
<SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-15</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-FEB-11</StartMarketingDatePackage>
</NDC>
</NDCList>