{
"NDC": [
{
"NDCCode": "84677-027-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-027-05) ",
"NDC11Code": "84677-0027-05",
"ProductNDC": "84677-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-027-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (84677-027-30) ",
"NDC11Code": "84677-0027-30",
"ProductNDC": "84677-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-027-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (84677-027-90) ",
"NDC11Code": "84677-0027-90",
"ProductNDC": "84677-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-002-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-002-05) ",
"NDC11Code": "84677-0002-05",
"ProductNDC": "84677-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-003-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-003-05) ",
"NDC11Code": "84677-0003-05",
"ProductNDC": "84677-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-004-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-004-05) ",
"NDC11Code": "84677-0004-05",
"ProductNDC": "84677-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-005-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-005-05) ",
"NDC11Code": "84677-0005-05",
"ProductNDC": "84677-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-006-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-006-05) ",
"NDC11Code": "84677-0006-05",
"ProductNDC": "84677-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-007-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-007-05) ",
"NDC11Code": "84677-0007-05",
"ProductNDC": "84677-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250926",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "84677-026-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-026-05) ",
"NDC11Code": "84677-0026-05",
"ProductNDC": "84677-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-028-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (84677-028-05) ",
"NDC11Code": "84677-0028-05",
"ProductNDC": "84677-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "GSMS, Incorporated",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "84677-035-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-035-05) ",
"NDC11Code": "84677-0035-05",
"ProductNDC": "84677-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "84677-036-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-036-05) ",
"NDC11Code": "84677-0036-05",
"ProductNDC": "84677-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "84677-037-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-037-05) ",
"NDC11Code": "84677-0037-05",
"ProductNDC": "84677-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "84677-038-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-038-05) ",
"NDC11Code": "84677-0038-05",
"ProductNDC": "84677-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "11673-027-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (11673-027-05) ",
"NDC11Code": "11673-0027-05",
"ProductNDC": "11673-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Enteric Safety-coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130308",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TARGET Corporation",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130308",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "11788-027-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (11788-027-05) ",
"NDC11Code": "11788-0027-05",
"ProductNDC": "11788-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210562",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate USP is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. C 30H 53NO 11. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "13537-027-05",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-027-05) > 50 mL in 1 BOTTLE (13537-027-04)",
"NDC11Code": "13537-0027-05",
"ProductNDC": "13537-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Protege Expert",
"NonProprietaryName": "Ensulizole, Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110810",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation Ltd.",
"SubstanceName": "ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".03; .075; .05; .06; .039",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Provides high protection against sunburn. Retains SPF after 40 minutes of activity in the water."
},
{
"NDCCode": "17156-025-05",
"PackageDescription": "1 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01) ",
"NDC11Code": "17156-0025-05",
"ProductNDC": "17156-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceretec",
"NonProprietaryName": "Technetium Tc-99m Exametazime And Cobaltous Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019829",
"LabelerName": "Medi-Physics, Inc. dba GE Healthcare",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N",
"IndicationAndUsage": "Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: 1 Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. (1.1), 2 Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. (1.2).",
"Description": "Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: 1 One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative., 2 One vial of cobalt stabilizer containing a sterile, non-pyrogenic solution of 200 mcg cobaltous chloride 6-hydrate in 2 mL of Water for Injection."
},
{
"NDCCode": "21130-027-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-027-05) / 50 TABLET in 1 BOTTLE",
"NDC11Code": "21130-0027-05",
"ProductNDC": "21130-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Acid Controller",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "BETTER LIVING BRANDS LLC.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "21922-027-05",
"PackageDescription": "1 TUBE in 1 CARTON (21922-027-05) / 30 g in 1 TUBE",
"NDC11Code": "21922-0027-05",
"ProductNDC": "21922-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate Gel Usp, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212438",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210315",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate gel USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains allantoin, carbopol 974 P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "23155-027-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (23155-027-05) ",
"NDC11Code": "23155-0027-05",
"ProductNDC": "23155-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110107",
"EndMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071881",
"LabelerName": "Heritage Pharmaceuticals Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110107",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "30142-027-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (30142-027-05) ",
"NDC11Code": "30142-0027-05",
"ProductNDC": "30142-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Low Dose Safety Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130308",
"EndMarketingDate": "20240329",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "The Kroger Co.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130308",
"EndMarketingDatePackage": "20240329",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin."
},
{
"NDCCode": "36800-027-05",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (36800-027-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0027-05",
"ProductNDC": "36800-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Low Dose Safety Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130315",
"EndMarketingDate": "20221230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TOP CARE (Topco Associates LLC)",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130315",
"EndMarketingDatePackage": "20221230",
"SamplePackage": "N"
},
{
"NDCCode": "42385-027-01",
"PackageDescription": ".05 kg in 1 DRUM (42385-027-01)",
"NDC11Code": "42385-0027-01",
"ProductNDC": "42385-027",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080901",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aptuit Laurus Private Limited",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42385-027-05",
"PackageDescription": "1 kg in 1 DRUM (42385-027-05)",
"NDC11Code": "42385-0027-05",
"ProductNDC": "42385-027",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080901",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aptuit Laurus Private Limited",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52343-027-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (52343-027-05) ",
"NDC11Code": "52343-0027-05",
"ProductNDC": "52343-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070905",
"EndMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "52919-027-05",
"PackageDescription": "50 VIAL, GLASS in 1 CARTON (52919-027-05) / 5 mL in 1 VIAL, GLASS (52919-027-01) ",
"NDC11Code": "52919-0027-05",
"ProductNDC": "52919-027",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20171130",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Siegfried Hameln GmbH",
"SubstanceName": "CALCIUM CHLORIDE",
"StrengthNumber": ".04",
"StrengthUnit": "mmol/mL",
"Status": "Unfinished",
"LastUpdate": "2026-06-05",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "30-NOV-17"
},
{
"NDCCode": "61755-037-05",
"PackageDescription": "1 KIT in 1 DOSE PACK (61755-037-05) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) ",
"NDC11Code": "61755-0037-05",
"ProductNDC": "61755-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regen-cov",
"NonProprietaryName": "Casirivimab And Imdevimab",
"DosageFormName": "KIT",
"StartMarketingDate": "20210207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210207",
"SamplePackage": "N",
"IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
"Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
},
{
"NDCCode": "62191-027-05",
"PackageDescription": "1 TUBE in 1 PACKAGE (62191-027-05) > 50 g in 1 TUBE",
"NDC11Code": "62191-0027-05",
"ProductNDC": "62191-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oi Lin Deep Moisture Sunscreen Spf 30",
"NonProprietaryName": "Sunscreen, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181204",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sunrider Manufacturing L.P.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "139; 39",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181204",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>84677-027-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-027-05) </PackageDescription>
<NDC11Code>84677-0027-05</NDC11Code>
<ProductNDC>84677-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-027-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (84677-027-30) </PackageDescription>
<NDC11Code>84677-0027-30</NDC11Code>
<ProductNDC>84677-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-027-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (84677-027-90) </PackageDescription>
<NDC11Code>84677-0027-90</NDC11Code>
<ProductNDC>84677-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-002-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-002-05) </PackageDescription>
<NDC11Code>84677-0002-05</NDC11Code>
<ProductNDC>84677-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-003-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-003-05) </PackageDescription>
<NDC11Code>84677-0003-05</NDC11Code>
<ProductNDC>84677-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-004-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-004-05) </PackageDescription>
<NDC11Code>84677-0004-05</NDC11Code>
<ProductNDC>84677-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-005-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-005-05) </PackageDescription>
<NDC11Code>84677-0005-05</NDC11Code>
<ProductNDC>84677-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-006-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-006-05) </PackageDescription>
<NDC11Code>84677-0006-05</NDC11Code>
<ProductNDC>84677-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-007-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-007-05) </PackageDescription>
<NDC11Code>84677-0007-05</NDC11Code>
<ProductNDC>84677-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2), 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>84677-026-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-026-05) </PackageDescription>
<NDC11Code>84677-0026-05</NDC11Code>
<ProductNDC>84677-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-028-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (84677-028-05) </PackageDescription>
<NDC11Code>84677-0028-05</NDC11Code>
<ProductNDC>84677-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>GSMS, Incorporated</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets, USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84677-035-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-035-05) </PackageDescription>
<NDC11Code>84677-0035-05</NDC11Code>
<ProductNDC>84677-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>84677-036-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-036-05) </PackageDescription>
<NDC11Code>84677-0036-05</NDC11Code>
<ProductNDC>84677-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>84677-037-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-037-05) </PackageDescription>
<NDC11Code>84677-0037-05</NDC11Code>
<ProductNDC>84677-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>84677-038-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (84677-038-05) </PackageDescription>
<NDC11Code>84677-0038-05</NDC11Code>
<ProductNDC>84677-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>11673-027-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (11673-027-05) </PackageDescription>
<NDC11Code>11673-0027-05</NDC11Code>
<ProductNDC>11673-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Enteric Safety-coated</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130308</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130308</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11788-027-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (11788-027-05) </PackageDescription>
<NDC11Code>11788-0027-05</NDC11Code>
<ProductNDC>11788-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210562</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate USP is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. C 30H 53NO 11. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13537-027-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-027-05) > 50 mL in 1 BOTTLE (13537-027-04)</PackageDescription>
<NDC11Code>13537-0027-05</NDC11Code>
<ProductNDC>13537-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Protege Expert</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation Ltd.</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.03; .075; .05; .06; .039</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Provides high protection against sunburn. Retains SPF after 40 minutes of activity in the water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17156-025-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01) </PackageDescription>
<NDC11Code>17156-0025-05</NDC11Code>
<ProductNDC>17156-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceretec</ProprietaryName>
<NonProprietaryName>Technetium Tc-99m Exametazime And Cobaltous Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180925</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019829</ApplicationNumber>
<LabelerName>Medi-Physics, Inc. dba GE Healthcare</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: 1 Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. (1.1), 2 Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. (1.2).</IndicationAndUsage>
<Description>Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: 1 One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative., 2 One vial of cobalt stabilizer containing a sterile, non-pyrogenic solution of 200 mcg cobaltous chloride 6-hydrate in 2 mL of Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>21130-027-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-027-05) / 50 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0027-05</NDC11Code>
<ProductNDC>21130-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Acid Controller</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>BETTER LIVING BRANDS LLC.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21922-027-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-027-05) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0027-05</NDC11Code>
<ProductNDC>21922-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate Gel Usp, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212438</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate gel USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The gel contains allantoin, carbopol 974 P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1 methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>23155-027-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (23155-027-05) </PackageDescription>
<NDC11Code>23155-0027-05</NDC11Code>
<ProductNDC>23155-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110107</StartMarketingDate>
<EndMarketingDate>20200430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071881</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110107</StartMarketingDatePackage>
<EndMarketingDatePackage>20200430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-027-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (30142-027-05) </PackageDescription>
<NDC11Code>30142-0027-05</NDC11Code>
<ProductNDC>30142-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Low Dose Safety Coated</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130308</StartMarketingDate>
<EndMarketingDate>20240329</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130308</StartMarketingDatePackage>
<EndMarketingDatePackage>20240329</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-027-05</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (36800-027-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0027-05</NDC11Code>
<ProductNDC>36800-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Low Dose Safety Coated</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<EndMarketingDate>20221230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>TOP CARE (Topco Associates LLC)</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<EndMarketingDatePackage>20221230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42385-027-01</NDCCode>
<PackageDescription>.05 kg in 1 DRUM (42385-027-01)</PackageDescription>
<NDC11Code>42385-0027-01</NDC11Code>
<ProductNDC>42385-027</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aptuit Laurus Private Limited</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42385-027-05</NDCCode>
<PackageDescription>1 kg in 1 DRUM (42385-027-05)</PackageDescription>
<NDC11Code>42385-0027-05</NDC11Code>
<ProductNDC>42385-027</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aptuit Laurus Private Limited</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52343-027-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (52343-027-05) </PackageDescription>
<NDC11Code>52343-0027-05</NDC11Code>
<ProductNDC>52343-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20201201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<EndMarketingDatePackage>20201201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52919-027-05</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 CARTON (52919-027-05) / 5 mL in 1 VIAL, GLASS (52919-027-01) </PackageDescription>
<NDC11Code>52919-0027-05</NDC11Code>
<ProductNDC>52919-027</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20171130</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Siegfried Hameln GmbH</LabelerName>
<SubstanceName>CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mmol/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-05</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-NOV-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61755-037-05</NDCCode>
<PackageDescription>1 KIT in 1 DOSE PACK (61755-037-05) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) > 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-027-01) > 2.5 mL in 1 VIAL, GLASS (61755-027-00) </PackageDescription>
<NDC11Code>61755-0037-05</NDC11Code>
<ProductNDC>61755-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regen-cov</ProprietaryName>
<NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
<Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>62191-027-05</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (62191-027-05) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62191-0027-05</NDC11Code>
<ProductNDC>62191-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oi Lin Deep Moisture Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Sunscreen, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sunrider Manufacturing L.P.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>139; 39</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>