{
"NDC": [
{
"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": "51759-740-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-740-11) / .42 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0740-11",
"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": "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": "51759-347-50",
"PackageDescription": "1 KIT in 1 CARTON (51759-347-50) * .9 mL in 1 VIAL (51759-353-50) * 1.1 mL in 1 SYRINGE (51759-356-10) ",
"NDC11Code": "51759-0347-50",
"ProductNDC": "51759-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Weltruza",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20261102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219007",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261102",
"SamplePackage": "N",
"IndicationAndUsage": "WELTRUZA is indicated for the treatment of schizophrenia in adults.",
"Description": "WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg."
},
{
"NDCCode": "51759-348-50",
"PackageDescription": "1 KIT in 1 CARTON (51759-348-50) * 1.2 mL in 1 VIAL (51759-354-50) * 1.3 mL in 1 SYRINGE (51759-357-10) ",
"NDC11Code": "51759-0348-50",
"ProductNDC": "51759-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Weltruza",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20261102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219007",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261102",
"SamplePackage": "N",
"IndicationAndUsage": "WELTRUZA is indicated for the treatment of schizophrenia in adults.",
"Description": "WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg."
},
{
"NDCCode": "51759-349-50",
"PackageDescription": "1 KIT in 1 CARTON (51759-349-50) * 1.5 mL in 1 VIAL (51759-355-50) * 1.5 mL in 1 SYRINGE (51759-358-10) ",
"NDC11Code": "51759-0349-50",
"ProductNDC": "51759-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Weltruza",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20261102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219007",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261102",
"SamplePackage": "N",
"IndicationAndUsage": "WELTRUZA is indicated for the treatment of schizophrenia in adults.",
"Description": "WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg."
},
{
"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": "51759-850-10",
"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": "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": "49836-740-01",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (49836-740-01) * 2 mL in 1 AMPULE * 2 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE * 6.5 mL in 1 PACKET * 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "49836-0740-01",
"ProductNDC": "49836-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mlp A-1",
"NonProprietaryName": "Bupivacaine Hydrochloride, Lidocaine Hydrochloride, Triamcinolone Acetonide, And Povidone-iodine",
"DosageFormName": "KIT",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "RX PHARMA-PACK, INC.",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51811-740-10",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (51811-740-10) ",
"NDC11Code": "51811-0740-10",
"ProductNDC": "51811-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Hanover Pen Corp dba HPC Global",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "82.6",
"StrengthUnit": "mL/118mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100913",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "52959-740-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (52959-740-10)",
"NDC11Code": "52959-0740-10",
"ProductNDC": "52959-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat."
},
{
"NDCCode": "55513-740-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) ",
"NDC11Code": "55513-0740-10",
"ProductNDC": "55513-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parsabiv",
"NonProprietaryName": "Etelcalcetide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208325",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ETELCALCETIDE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170403",
"SamplePackage": "N",
"IndicationAndUsage": "PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.",
"Description": "PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "55513-740-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) ",
"NDC11Code": "55513-0740-20",
"ProductNDC": "55513-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parsabiv",
"NonProprietaryName": "Etelcalcetide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208325",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ETELCALCETIDE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.",
"Description": "PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "55648-740-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55648-740-01) > 10 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "55648-0740-01",
"ProductNDC": "55648-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078884",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
},
{
"NDCCode": "55648-740-03",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-740-03) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "55648-0740-03",
"ProductNDC": "55648-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078884",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
},
{
"NDCCode": "57218-740-02",
"PackageDescription": "10 kg in 1 DRUM (57218-740-02)",
"NDC11Code": "57218-0740-02",
"ProductNDC": "57218-740",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Meglumine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Malladi Drugs & Pharmaceuticals Limited",
"SubstanceName": "MEGLUMINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "58160-740-21",
"PackageDescription": "10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02) ",
"NDC11Code": "58160-0740-21",
"ProductNDC": "58160-740",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rotarix",
"NonProprietaryName": "Rotavirus Vaccine, Live, Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125265",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN",
"StrengthNumber": "1000",
"StrengthUnit": "[CCID_50]/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.",
"Description": "ROTARIX (Rotavirus Vaccine, Live, Oral) is an orally administered live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. ROTARIX is an oral solution available in a ready-to-use liquid formulation (supplied in an oral dosing applicator). Each 1.5 mL dose of ROTARIX contains at least 106.0 Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. ROTARIX contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. ROTARIX contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. ROTARIX is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip cap and plunger stopper of the prefilled oral dosing applicator are not made with natural rubber latex. ROTARIX contains no preservatives."
},
{
"NDCCode": "58657-740-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (58657-740-10) ",
"NDC11Code": "58657-0740-10",
"ProductNDC": "58657-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213827",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets, USP, are indicated for the treatment of salt and water retention including. · edema accompanying congestive heart failure;. · edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. Usage In Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.",
"Description": "Metolazone tablets, USP, for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1,2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4- oxo-6-quinazolinesulfonamide and a molecular weight of 365.83. The structural formula is. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and dye: 2 ½ mg o. 6; 5 mg - D&C Red #30; 10 mg - FD&C Yellow No.6."
},
{
"NDCCode": "60687-740-37",
"PackageDescription": "10 TRAY in 1 CASE (60687-740-37) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-740-53) / 20.3 mL in 1 CUP, UNIT-DOSE (60687-740-24) ",
"NDC11Code": "60687-0740-37",
"ProductNDC": "60687-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230727",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "American Health Packaging",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/20.3mL",
"Status": "Active",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230727",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever."
},
{
"NDCCode": "63187-740-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (63187-740-10) ",
"NDC11Code": "63187-0740-10",
"ProductNDC": "63187-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digox",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076268",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171101",
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"IndicationAndUsage": "Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid."
},
{
"NDCCode": "64679-740-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (64679-740-01) > 10 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "64679-0740-01",
"ProductNDC": "64679-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078884",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20080731",
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"IndicationAndUsage": "● relieves heartburn associated with acid indigestion and sour stomach. ● prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
},
{
"NDCCode": "64679-740-03",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-740-03) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0740-03",
"ProductNDC": "64679-740",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078884",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
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"IndicationAndUsage": "● relieves heartburn associated with acid indigestion and sour stomach. ● prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
},
{
"NDCCode": "65841-740-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65841-740-10) ",
"NDC11Code": "65841-0740-10",
"ProductNDC": "65841-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077751",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100330",
"SamplePackage": "N"
},
{
"NDCCode": "65862-740-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65862-740-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-740-10) ",
"NDC11Code": "65862-0740-03",
"ProductNDC": "65862-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206512",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160422",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and valsartan tablets are the combination of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan tablets USP are a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets USP contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: Its molecular formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan USP is a white, fine hygroscopic powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets USP are formulated in 4 strengths for oral administration with a combination of amlodipine besylate USP (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with 160 mg, or 320 mg of valsartan USP providing for the following available combinations: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), and sodium starch glycolate. Additionally, the 5 mg/320 mg and 10 mg/160 mg strengths contain iron oxide red. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol, talc, and titanium dioxide. USP Organic Impurities Test pending."
},
{
"NDCCode": "68382-740-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-10) ",
"NDC11Code": "68382-0740-10",
"ProductNDC": "68382-740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210395",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220203",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "The Potassium Chloride Extended-release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-release Tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within one minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients. Colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hyrpromellose, microcrystalline cellulose, polyethylene glycol and povidone. USP Assay preparation is pending."
}
]
}
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<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>
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<NDC>
<NDCCode>51759-740-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-740-11) / .42 mL in 1 SYRINGE, GLASS</PackageDescription>
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<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>
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<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>51759-347-50</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51759-347-50) * .9 mL in 1 VIAL (51759-353-50) * 1.1 mL in 1 SYRINGE (51759-356-10) </PackageDescription>
<NDC11Code>51759-0347-50</NDC11Code>
<ProductNDC>51759-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Weltruza</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219007</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WELTRUZA is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg.</Description>
</NDC>
<NDC>
<NDCCode>51759-348-50</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51759-348-50) * 1.2 mL in 1 VIAL (51759-354-50) * 1.3 mL in 1 SYRINGE (51759-357-10) </PackageDescription>
<NDC11Code>51759-0348-50</NDC11Code>
<ProductNDC>51759-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Weltruza</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219007</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WELTRUZA is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg.</Description>
</NDC>
<NDC>
<NDCCode>51759-349-50</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51759-349-50) * 1.5 mL in 1 VIAL (51759-355-50) * 1.5 mL in 1 SYRINGE (51759-358-10) </PackageDescription>
<NDC11Code>51759-0349-50</NDC11Code>
<ProductNDC>51759-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Weltruza</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219007</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WELTRUZA is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>WELTRUZA (olanzapine) for extended-release injectable suspension contains olanzapine, an atypical antipsychotic that belongs to the chemical class of thienobenzodiazepines. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17 H20 N4 S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline powder, which is very slightly soluble in water. A WELTRUZA kit contains olanzapine as a yellow powder that is packaged in a single dose glass vial and diluent in a prefilled syringe (PFS). Diluent is a frozen, opaque solid when stored at 2°C to 8°C (36°F to 46°F); and a clear, colorless, viscous solution at room temperature. The diluent is composed of methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (18% w/w), poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (5% w/w) copolymers and dimethyl sulfoxide (77% w/w). The olanzapine powder is reconstituted with the diluent to produce a suspension with a concentration of 354 mg/mL prior to subcutaneous injection. Upon reconstitution, WELTRUZA is available as a sterile extended-release injectable suspension, for subcutaneous use, in the following strengths of olanzapine: 318 mg, 425 mg, and 531 mg.</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>51759-850-10</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>51759-960-10</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-960-10) / .7 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0960-10</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>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>49836-740-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (49836-740-01) * 2 mL in 1 AMPULE * 2 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE * 6.5 mL in 1 PACKET * 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>49836-0740-01</NDC11Code>
<ProductNDC>49836-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mlp A-1</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride, Lidocaine Hydrochloride, Triamcinolone Acetonide, And Povidone-iodine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014901</ApplicationNumber>
<LabelerName>RX PHARMA-PACK, INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51811-740-10</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (51811-740-10) </PackageDescription>
<NDC11Code>51811-0740-10</NDC11Code>
<ProductNDC>51811-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antimicrobial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Hanover Pen Corp dba HPC Global</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>82.6</StrengthNumber>
<StrengthUnit>mL/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-740-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (52959-740-10)</PackageDescription>
<NDC11Code>52959-0740-10</NDC11Code>
<ProductNDC>52959-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55513-740-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) </PackageDescription>
<NDC11Code>55513-0740-10</NDC11Code>
<ProductNDC>55513-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parsabiv</ProprietaryName>
<NonProprietaryName>Etelcalcetide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208325</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ETELCALCETIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.</IndicationAndUsage>
<Description>PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>55513-740-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) </PackageDescription>
<NDC11Code>55513-0740-20</NDC11Code>
<ProductNDC>55513-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parsabiv</ProprietaryName>
<NonProprietaryName>Etelcalcetide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208325</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ETELCALCETIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.</IndicationAndUsage>
<Description>PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C38H73N21O10S2∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water. The hydrochloride salt of etelcalcetide is described chemically as N-acetyl-D-cysteinyl-S-(L-cysteine disulfide)-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-D-argininamide hydrochloride. PARSABIV (etelcalcetide) injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection. Each PARSABIV single-dose vial contains 2.5 mg etelcalcetide (equivalent to 2.88 mg etelcalcetide as hydrochloride salt) or 5 mg etelcalcetide (equivalent to 5.77 mg etelcalcetide as hydrochloride salt) or 10 mg etelcalcetide (equivalent to 11.54 mg etelcalcetide as hydrochloride salt). PARSABIV single-dose vial is formulated with 0.85% (w/v) sodium chloride, 10 mM succinic acid, and adjusted to pH 3.3 with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>55648-740-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55648-740-01) > 10 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55648-0740-01</NDC11Code>
<ProductNDC>55648-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078884</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-740-03</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-740-03) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0740-03</NDC11Code>
<ProductNDC>55648-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078884</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57218-740-02</NDCCode>
<PackageDescription>10 kg in 1 DRUM (57218-740-02)</PackageDescription>
<NDC11Code>57218-0740-02</NDC11Code>
<ProductNDC>57218-740</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Meglumine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Malladi Drugs & Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEGLUMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58160-740-21</NDCCode>
<PackageDescription>10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02) </PackageDescription>
<NDC11Code>58160-0740-21</NDC11Code>
<ProductNDC>58160-740</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rotarix</ProprietaryName>
<NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125265</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[CCID_50]/mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.</IndicationAndUsage>
<Description>ROTARIX (Rotavirus Vaccine, Live, Oral) is an orally administered live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. ROTARIX is an oral solution available in a ready-to-use liquid formulation (supplied in an oral dosing applicator). Each 1.5 mL dose of ROTARIX contains at least 106.0 Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. ROTARIX contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. ROTARIX contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. ROTARIX is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip cap and plunger stopper of the prefilled oral dosing applicator are not made with natural rubber latex. ROTARIX contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58657-740-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (58657-740-10) </PackageDescription>
<NDC11Code>58657-0740-10</NDC11Code>
<ProductNDC>58657-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213827</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets, USP, are indicated for the treatment of salt and water retention including. · edema accompanying congestive heart failure;. · edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. Usage In Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.</IndicationAndUsage>
<Description>Metolazone tablets, USP, for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1,2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4- oxo-6-quinazolinesulfonamide and a molecular weight of 365.83. The structural formula is. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and dye: 2 ½ mg o. 6; 5 mg - D&C Red #30; 10 mg - FD&C Yellow No.6.</Description>
</NDC>
<NDC>
<NDCCode>60687-740-37</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (60687-740-37) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-740-53) / 20.3 mL in 1 CUP, UNIT-DOSE (60687-740-24) </PackageDescription>
<NDC11Code>60687-0740-37</NDC11Code>
<ProductNDC>60687-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/20.3mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps, 8 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-740-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (63187-740-10) </PackageDescription>
<NDC11Code>63187-0740-10</NDC11Code>
<ProductNDC>63187-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digox</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076268</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-0-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>64679-740-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64679-740-01) > 10 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>64679-0740-01</NDC11Code>
<ProductNDC>64679-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078884</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● relieves heartburn associated with acid indigestion and sour stomach. ● prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64679-740-03</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-740-03) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0740-03</NDC11Code>
<ProductNDC>64679-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078884</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● relieves heartburn associated with acid indigestion and sour stomach. ● prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65841-740-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (65841-740-10) </PackageDescription>
<NDC11Code>65841-0740-10</NDC11Code>
<ProductNDC>65841-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077751</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-740-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (65862-740-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-740-10) </PackageDescription>
<NDC11Code>65862-0740-03</NDC11Code>
<ProductNDC>65862-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206512</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and valsartan tablets are the combination of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan tablets USP are a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets USP contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: Its molecular formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan USP is a white, fine hygroscopic powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets USP are formulated in 4 strengths for oral administration with a combination of amlodipine besylate USP (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with 160 mg, or 320 mg of valsartan USP providing for the following available combinations: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), and sodium starch glycolate. Additionally, the 5 mg/320 mg and 10 mg/160 mg strengths contain iron oxide red. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol, talc, and titanium dioxide. USP Organic Impurities Test pending.</Description>
</NDC>
<NDC>
<NDCCode>68382-740-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-740-10) </PackageDescription>
<NDC11Code>68382-0740-10</NDC11Code>
<ProductNDC>68382-740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210395</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>The Potassium Chloride Extended-release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-release Tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within one minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients. Colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hyrpromellose, microcrystalline cellulose, polyethylene glycol and povidone. USP Assay preparation is pending.</Description>
</NDC>
</NDCList>