{
"NDC": [
{
"NDCCode": "51759-960-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-960-10) / .7 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0960-10",
"ProductNDC": "51759-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "250",
"StrengthUnit": "mg/.7mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-960-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-960-11) / .7 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0960-11",
"ProductNDC": "51759-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "250",
"StrengthUnit": "mg/.7mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "Y",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-202-10",
"PackageDescription": "1 CONTAINER in 1 CARTON (51759-202-10) / 1.5 mL in 1 CONTAINER",
"NDC11Code": "51759-0202-10",
"ProductNDC": "51759-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ajovy",
"NonProprietaryName": "Fremanezumab-vfrm",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200329",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761089",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FREMANEZUMAB",
"StrengthNumber": "225",
"StrengthUnit": "mg/1.5mL",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200329",
"SamplePackage": "N",
"IndicationAndUsage": "AJOVY is indicated for: : 1 the preventive treatment of migraine in adults, and , 2 the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.",
"Description": "Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa. AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe. Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5."
},
{
"NDCCode": "51759-204-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-204-10) / 1.5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0204-10",
"ProductNDC": "51759-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ajovy",
"NonProprietaryName": "Fremanezumab-vfrm",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761089",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FREMANEZUMAB",
"StrengthNumber": "225",
"StrengthUnit": "mg/1.5mL",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180915",
"SamplePackage": "N",
"IndicationAndUsage": "AJOVY is indicated for: : 1 the preventive treatment of migraine in adults, and , 2 the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.",
"Description": "Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa. AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe. Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5."
},
{
"NDCCode": "51759-305-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0305-10",
"ProductNDC": "51759-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/.14mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-410-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-410-10) / .21 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0410-10",
"ProductNDC": "51759-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "75",
"StrengthUnit": "mg/.21mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-520-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-520-10) / .28 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0520-10",
"ProductNDC": "51759-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/.28mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-630-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-630-10) / .35 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0630-10",
"ProductNDC": "51759-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/.35mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-740-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-740-10) / .42 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0740-10",
"ProductNDC": "51759-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "150",
"StrengthUnit": "mg/.42mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "51759-850-10",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-850-10) / .56 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0850-10",
"ProductNDC": "51759-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/.56mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "43744-960-10",
"PackageDescription": "1 g in 1 DRUM (43744-960-10)",
"NDC11Code": "43744-0960-10",
"ProductNDC": "43744-960",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tylosin Tartrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "TYLOSIN TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43744-960-15",
"PackageDescription": "10 g in 1 DRUM (43744-960-15)",
"NDC11Code": "43744-0960-15",
"ProductNDC": "43744-960",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tylosin Tartrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "TYLOSIN TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "50383-960-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50383-960-10) ",
"NDC11Code": "50383-0960-10",
"ProductNDC": "50383-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protriptyline Hydrochloride",
"NonProprietaryName": "Protriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202220",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "PROTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131028",
"SamplePackage": "N"
},
{
"NDCCode": "51079-960-56",
"PackageDescription": "10 DOSE PACK in 1 CARTON (51079-960-56) > 30 BLISTER PACK in 1 DOSE PACK (51079-960-30) > 1 TABLET in 1 BLISTER PACK (51079-960-01)",
"NDC11Code": "51079-0960-56",
"ProductNDC": "51079-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54575-960-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-960-10)",
"NDC11Code": "54575-0960-10",
"ProductNDC": "54575-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pecan Pollen",
"NonProprietaryName": "Carya Illinoinensis Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "CARYA ILLINOINENSIS POLLEN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "59011-960-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS",
"NDC11Code": "59011-0960-10",
"ProductNDC": "59011-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nalmefene Hydrochloride",
"NonProprietaryName": "Nalmefene Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212955",
"LabelerName": "Knoa Pharma LLC",
"SubstanceName": "NALMEFENE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.",
"Description": "Nalmefene hydrochloride injection, an opioid antagonist, is a 6-methylene analogue of naltrexone. The chemical structure is shown below. Molecular Formula: C21H25NO3∙HCl. Molecular Weight: 375.9, CAS # 58895-64-0. Chemical Name: 17-(Cyclopropylmethyl)-4,5a-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt. Nalmefene hydrochloride is a white to off-white crystalline powder which is freely soluble in water up to 130 mg/mL and slightly soluble in chloroform up to 0.13 mg/mL, with a pKa of 7.6. Nalmefene hydrochloride injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration in concentration of 1 mg of nalmefene free base per mL. The 1 mg/mL concentration contains 1.108 mg of nalmefene hydrochloride per mL, 9.0 mg of sodium chloride per mL, and the pH is adjusted to 3.9 with hydrochloric acid. Concentration and dosage of nalmefene hydrochloride injection are expressed as the free base equivalent of nalmefene."
},
{
"NDCCode": "59676-960-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (59676-960-01) > 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "59676-0960-01",
"ProductNDC": "59676-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxil",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SUSPENSION, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19951117",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050718",
"LabelerName": "Janssen Products, LP",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951117",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "62135-960-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (62135-960-10) ",
"NDC11Code": "62135-0960-10",
"ProductNDC": "62135-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfasalazine",
"NonProprietaryName": "Sulfasalazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19731112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080197",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "SULFASALAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2022-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210507",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfasalazine Tablets are indicated. a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and. b) for the prolongation of the remission period between acute attacks of ulcerative colitis.",
"Description": "Sulfasalazine Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C 18H 14N 4O 5S. Inactive ingredients: Corn starch, magnesium stearate, pregelatinized starch, stearic acid."
},
{
"NDCCode": "62559-960-10",
"PackageDescription": "1000 mL in 1 BOTTLE (62559-960-10) ",
"NDC11Code": "62559-0960-10",
"ProductNDC": "62559-960",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol Antiseptic 75%",
"NonProprietaryName": "Isopropyl Alcohol Antiseptic 75%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200427",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200427",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "63323-960-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01) ",
"NDC11Code": "63323-0960-10",
"ProductNDC": "63323-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tigecycline",
"NonProprietaryName": "Tigecycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205645",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "TIGECYCLINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"Description": "Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4S,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The following represents the chemical structure of tigecycline:. Figure 1: Structure of Tigecycline. Tigecycline for injection, USP is an orange lyophilized powder or cake. Each tigecycline single dose 10 mL vial contains 50 mg tigecycline and 82.6 mg of arginine as lyophilized powder for reconstitution for intravenous infusion. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives."
},
{
"NDCCode": "50090-7718-0",
"PackageDescription": "24 KIT in 1 CASE (50090-7718-0) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (51759-513-21) * .4 mL in 1 POUCH (65517-0002-1) ",
"NDC11Code": "50090-7718-00",
"ProductNDC": "50090-7718",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simlandi",
"NonProprietaryName": "Adalimumab-ryvk",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761299",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251016",
"SamplePackage": "N",
"IndicationAndUsage": "SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. (1.1) , 2 Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. (1.2) , 3 Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. (1.3) , 4 Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS. (1.4) , 5 Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) , 6 Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7) , 8 Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8) , 9 Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9) .",
"Description": "Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. SIMLANDI® (adalimumab-ryvk) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SIMLANDI autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of SIMLANDI is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of SIMLANDI contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of SIMLANDI contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of SIMLANDI contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH."
},
{
"NDCCode": "51759-208-13",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "51759-0208-13",
"ProductNDC": "51759-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epysqli",
"NonProprietaryName": "Eculizumab-aagh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250407",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761340",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ECULIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Complement Inhibitor [EPC], Complement Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250407",
"SamplePackage": "N",
"IndicationAndUsage": "EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. (1.3), 4 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.4).",
"Description": "Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7."
},
{
"NDCCode": "51759-413-32",
"PackageDescription": "1 TRAY in 1 CARTON (51759-413-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0413-32",
"ProductNDC": "51759-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustekinumab-aekn",
"NonProprietaryName": "Ustekinumab-aekn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761343",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "USTEKINUMAB-AEKN",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251223",
"SamplePackage": "N",
"IndicationAndUsage": "Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aekn injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. Ustekinumab-aekn for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). Ustekinumab-aekn for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s)."
},
{
"NDCCode": "51759-414-32",
"PackageDescription": "1 TRAY in 1 CARTON (51759-414-32) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0414-32",
"ProductNDC": "51759-414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustekinumab-aekn",
"NonProprietaryName": "Ustekinumab-aekn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761343",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "USTEKINUMAB-AEKN",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251223",
"SamplePackage": "N",
"IndicationAndUsage": "Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
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<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-960-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-960-11) / .7 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0960-11</NDC11Code>
<ProductNDC>51759-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/.7mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-202-10</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51759-202-10) / 1.5 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>51759-0202-10</NDC11Code>
<ProductNDC>51759-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ajovy</ProprietaryName>
<NonProprietaryName>Fremanezumab-vfrm</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200329</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761089</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FREMANEZUMAB</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AJOVY is indicated for: : 1 the preventive treatment of migraine in adults, and , 2 the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.</IndicationAndUsage>
<Description>Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa. AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe. Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>51759-204-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-204-10) / 1.5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0204-10</NDC11Code>
<ProductNDC>51759-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ajovy</ProprietaryName>
<NonProprietaryName>Fremanezumab-vfrm</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761089</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FREMANEZUMAB</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AJOVY is indicated for: : 1 the preventive treatment of migraine in adults, and , 2 the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.</IndicationAndUsage>
<Description>Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa. AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe. Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>51759-305-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0305-10</NDC11Code>
<ProductNDC>51759-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/.14mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-410-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-410-10) / .21 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0410-10</NDC11Code>
<ProductNDC>51759-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/.21mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-520-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-520-10) / .28 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0520-10</NDC11Code>
<ProductNDC>51759-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/.28mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-630-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-630-10) / .35 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0630-10</NDC11Code>
<ProductNDC>51759-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/.35mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-740-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-740-10) / .42 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0740-10</NDC11Code>
<ProductNDC>51759-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/.42mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>51759-850-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-850-10) / .56 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0850-10</NDC11Code>
<ProductNDC>51759-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/.56mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>43744-960-10</NDCCode>
<PackageDescription>1 g in 1 DRUM (43744-960-10)</PackageDescription>
<NDC11Code>43744-0960-10</NDC11Code>
<ProductNDC>43744-960</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tylosin Tartrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>TYLOSIN TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-960-15</NDCCode>
<PackageDescription>10 g in 1 DRUM (43744-960-15)</PackageDescription>
<NDC11Code>43744-0960-15</NDC11Code>
<ProductNDC>43744-960</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tylosin Tartrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>TYLOSIN TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50383-960-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50383-960-10) </PackageDescription>
<NDC11Code>50383-0960-10</NDC11Code>
<ProductNDC>50383-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Protriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202220</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>PROTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-960-56</NDCCode>
<PackageDescription>10 DOSE PACK in 1 CARTON (51079-960-56) > 30 BLISTER PACK in 1 DOSE PACK (51079-960-30) > 1 TABLET in 1 BLISTER PACK (51079-960-01)</PackageDescription>
<NDC11Code>51079-0960-56</NDC11Code>
<ProductNDC>51079-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54575-960-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-960-10)</PackageDescription>
<NDC11Code>54575-0960-10</NDC11Code>
<ProductNDC>54575-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pecan Pollen</ProprietaryName>
<NonProprietaryName>Carya Illinoinensis Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>CARYA ILLINOINENSIS POLLEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>59011-960-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>59011-0960-10</NDC11Code>
<ProductNDC>59011-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nalmefene Hydrochloride</ProprietaryName>
<NonProprietaryName>Nalmefene Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212955</ApplicationNumber>
<LabelerName>Knoa Pharma LLC</LabelerName>
<SubstanceName>NALMEFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.</IndicationAndUsage>
<Description>Nalmefene hydrochloride injection, an opioid antagonist, is a 6-methylene analogue of naltrexone. The chemical structure is shown below. Molecular Formula: C21H25NO3∙HCl. Molecular Weight: 375.9, CAS # 58895-64-0. Chemical Name: 17-(Cyclopropylmethyl)-4,5a-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt. Nalmefene hydrochloride is a white to off-white crystalline powder which is freely soluble in water up to 130 mg/mL and slightly soluble in chloroform up to 0.13 mg/mL, with a pKa of 7.6. Nalmefene hydrochloride injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration in concentration of 1 mg of nalmefene free base per mL. The 1 mg/mL concentration contains 1.108 mg of nalmefene hydrochloride per mL, 9.0 mg of sodium chloride per mL, and the pH is adjusted to 3.9 with hydrochloric acid. Concentration and dosage of nalmefene hydrochloride injection are expressed as the free base equivalent of nalmefene.</Description>
</NDC>
<NDC>
<NDCCode>59676-960-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (59676-960-01) > 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>59676-0960-01</NDC11Code>
<ProductNDC>59676-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxil</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19951117</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050718</ApplicationNumber>
<LabelerName>Janssen Products, LP</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951117</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62135-960-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (62135-960-10) </PackageDescription>
<NDC11Code>62135-0960-10</NDC11Code>
<ProductNDC>62135-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfasalazine</ProprietaryName>
<NonProprietaryName>Sulfasalazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19731112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080197</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>SULFASALAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfasalazine Tablets are indicated. a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and. b) for the prolongation of the remission period between acute attacks of ulcerative colitis.</IndicationAndUsage>
<Description>Sulfasalazine Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C 18H 14N 4O 5S. Inactive ingredients: Corn starch, magnesium stearate, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62559-960-10</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (62559-960-10) </PackageDescription>
<NDC11Code>62559-0960-10</NDC11Code>
<ProductNDC>62559-960</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol Antiseptic 75%</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol Antiseptic 75%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200427</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200427</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-960-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01) </PackageDescription>
<NDC11Code>63323-0960-10</NDC11Code>
<ProductNDC>63323-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tigecycline</ProprietaryName>
<NonProprietaryName>Tigecycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205645</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>TIGECYCLINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4S,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The following represents the chemical structure of tigecycline:. Figure 1: Structure of Tigecycline. Tigecycline for injection, USP is an orange lyophilized powder or cake. Each tigecycline single dose 10 mL vial contains 50 mg tigecycline and 82.6 mg of arginine as lyophilized powder for reconstitution for intravenous infusion. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives.</Description>
</NDC>
<NDC>
<NDCCode>50090-7718-0</NDCCode>
<PackageDescription>24 KIT in 1 CASE (50090-7718-0) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (51759-513-21) * .4 mL in 1 POUCH (65517-0002-1) </PackageDescription>
<NDC11Code>50090-7718-00</NDC11Code>
<ProductNDC>50090-7718</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simlandi</ProprietaryName>
<NonProprietaryName>Adalimumab-ryvk</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761299</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. (1.1) , 2 Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. (1.2) , 3 Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. (1.3) , 4 Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS. (1.4) , 5 Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) , 6 Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7) , 8 Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8) , 9 Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9) .</IndicationAndUsage>
<Description>Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. SIMLANDI® (adalimumab-ryvk) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SIMLANDI autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of SIMLANDI is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of SIMLANDI contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of SIMLANDI contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of SIMLANDI contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>51759-208-13</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>51759-0208-13</NDC11Code>
<ProductNDC>51759-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epysqli</ProprietaryName>
<NonProprietaryName>Eculizumab-aagh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250407</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761340</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ECULIZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Complement Inhibitor [EPC], Complement Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPYSQLI is a complement inhibitor indicated for: 1 the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (1.1), 2 the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (1.2)Limitation of UseEPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)., 3 the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. (1.3), 4 the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. (1.4).</IndicationAndUsage>
<Description>Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7.</Description>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
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<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2026-08-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aekn injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. Ustekinumab-aekn for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). Ustekinumab-aekn for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aekn injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. Ustekinumab-aekn for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). Ustekinumab-aekn for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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<PackageDescription>1 VIAL in 1 CARTON (51759-505-13) / .5 mL in 1 VIAL</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selarsdi</ProprietaryName>
<NonProprietaryName>Ustekinumab-aekn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). SELARSDI for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). SELARSDI for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). SELARSDI for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>20250312</StartMarketingDate>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
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<StrengthUnit>mg/26mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). SELARSDI for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ustekinumab-aekn</ProprietaryName>
<NonProprietaryName>Ustekinumab-aekn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
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<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aekn injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. Ustekinumab-aekn for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). Ustekinumab-aekn for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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<PackageDescription>1 TRAY in 1 CARTON (51759-710-32) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ustekinumab-aekn</ProprietaryName>
<NonProprietaryName>Ustekinumab-aekn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761343</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-AEKN</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4) Pediatric patients 6 years and older with:, 5 moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. (1.1), 6 active psoriatic arthritis (PsA). (1.2).</IndicationAndUsage>
<Description>Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aekn injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. Ustekinumab-aekn for Subcutaneous Use. Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). Ustekinumab-aekn for Intravenous Infusion. Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).</Description>
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