{
"NDC": [
{
"NDCCode": "76385-180-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (76385-180-50) ",
"NDC11Code": "76385-0180-50",
"ProductNDC": "76385-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "76385-180-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (76385-180-10) ",
"NDC11Code": "76385-0180-10",
"ProductNDC": "76385-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "76385-180-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (76385-180-30) ",
"NDC11Code": "76385-0180-30",
"ProductNDC": "76385-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "76385-180-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76385-180-90) ",
"NDC11Code": "76385-0180-90",
"ProductNDC": "76385-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "76385-110-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-110-50) ",
"NDC11Code": "76385-0110-50",
"ProductNDC": "76385-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"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": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "76385-111-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-50) ",
"NDC11Code": "76385-0111-50",
"ProductNDC": "76385-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"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": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "76385-112-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-50) ",
"NDC11Code": "76385-0112-50",
"ProductNDC": "76385-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"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": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "76385-113-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-113-50) ",
"NDC11Code": "76385-0113-50",
"ProductNDC": "76385-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "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": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "76385-114-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-114-50) ",
"NDC11Code": "76385-0114-50",
"ProductNDC": "76385-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207428",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171215",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-115-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-115-50) ",
"NDC11Code": "76385-0115-50",
"ProductNDC": "76385-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207428",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-116-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-116-50) ",
"NDC11Code": "76385-0116-50",
"ProductNDC": "76385-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207428",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-123-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (76385-123-50) ",
"NDC11Code": "76385-0123-50",
"ProductNDC": "76385-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "76385-124-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (76385-124-50) ",
"NDC11Code": "76385-0124-50",
"ProductNDC": "76385-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "76385-125-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-125-50) ",
"NDC11Code": "76385-0125-50",
"ProductNDC": "76385-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"ProprietaryNameSuffix": "Af",
"NonProprietaryName": "Sotalol Hydrochloride Tables Af",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207429",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-126-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-126-50) ",
"NDC11Code": "76385-0126-50",
"ProductNDC": "76385-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"ProprietaryNameSuffix": "Af",
"NonProprietaryName": "Sotalol Hydrochloride Tables Af",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207429",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-127-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50) ",
"NDC11Code": "76385-0127-50",
"ProductNDC": "76385-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"ProprietaryNameSuffix": "Af",
"NonProprietaryName": "Sotalol Hydrochloride Tablets Af",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207429",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).",
"Description": "Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide."
},
{
"NDCCode": "76385-128-50",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50) ",
"NDC11Code": "76385-0128-50",
"ProductNDC": "76385-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207427",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190725",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate.System Components and Performance- Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
},
{
"NDCCode": "76385-129-50",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-129-50) ",
"NDC11Code": "76385-0129-50",
"ProductNDC": "76385-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207427",
"LabelerName": "UNICHEM PHARMACEUTICALS (USA), INC.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180717",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate.System Components and Performance- Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
},
{
"NDCCode": "76385-142-05",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (76385-142-05) ",
"NDC11Code": "76385-0142-05",
"ProductNDC": "76385-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloroquine Phosphate",
"NonProprietaryName": "Chloroquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090610",
"LabelerName": "Bayshore Pharmaceuticals LLC",
"SubstanceName": "CHLOROQUINE PHOSPHATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200415",
"SamplePackage": "N",
"IndicationAndUsage": "Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale , and P.vivax.",
"Description": "Chloroquine phosphate tablet, USP is a 4-aminoquinoline compound for oral administration. It is a white crystalline powder, odorless, has a bitter taste, and is discolored slowly on exposure to light. It is freely soluble in water, practically insoluble in alcohol, in chloroform and in ether. Chloroquine phosphate tablet, USP is an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula. C 18H 26CIN 3.2H 3PO 4 Molecular Weight: 515.86. Each tablet contains 250 mg of chloroquine phosphate USP, equivalent to 150 mg chloroquine base. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "76385-144-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (76385-144-50) ",
"NDC11Code": "76385-0144-50",
"ProductNDC": "76385-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040766",
"LabelerName": "Bayshore Pharmaceuticals LLC",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum,Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate, USP is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, in chloroform, and in ether. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized starch, talc, and titanium dioxide."
},
{
"NDCCode": "76385-178-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (76385-178-50) ",
"NDC11Code": "76385-0178-50",
"ProductNDC": "76385-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "76385-179-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (76385-179-50) ",
"NDC11Code": "76385-0179-50",
"ProductNDC": "76385-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210165",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"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": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260625",
"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": "11489-180-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-180-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0180-01",
"ProductNDC": "11489-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Advanced Day Cream Spf 30",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210809",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.5; 2.5; 3.75",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210809",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.",
"Description": "No7 Protect & Perfect Intense ADVANCED Anti-Ageing Skincare System. Fine lines and wrinkles appear visibly reduced. Helps to protect from future signs of skin ageing. Younger looking skin in 2 weeks. 50 ml e 1.69 Fl. Oz. Day Cream. Advanded formula and all day hydration for visibly younger looking skin. Combining the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients, to reduce the appearance of the visible signs of ageing. The perfect partner to your No7 Protect & Perfect Intense ADVANCED serum, this day cream works to visibly reduce the appearance of fine lines and wrinkles in 4 weeks."
},
{
"NDCCode": "11534-180-50",
"PackageDescription": "510 g in 1 BOTTLE (11534-180-50) ",
"NDC11Code": "11534-0180-50",
"ProductNDC": "11534-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 Nf",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206105",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2020-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170613",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "13733-180-01",
"PackageDescription": "50 mL in 1 CARTON (13733-180-01)",
"NDC11Code": "13733-0180-01",
"ProductNDC": "13733-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha M Perfect Cover Bb No 31",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide, Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Able C&C Co., Ltd.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "3.5; 2.09; 3.75",
"StrengthUnit": "g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "13734-180-60",
"PackageDescription": "1 TUBE in 1 BOX (13734-180-60) / 50 mL in 1 TUBE",
"NDC11Code": "13734-0180-60",
"ProductNDC": "13734-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nars Pure Radiant Tinted Moisturizer",
"ProprietaryNameSuffix": "Alaska",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "NARS Cosmetics",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "4.044; 3.996",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251217",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunbun. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "21130-180-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-180-71) / 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "21130-0180-71",
"ProductNDC": "21130-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "Safeway",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211123",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. minor pain of arthritis . muscular aches. backache. menstrual cramps. headache. toothache. the common cold. temporarily reduces fever."
},
{
"NDCCode": "24909-180-50",
"PackageDescription": "50 g in 1 TUBE (24909-180-50) ",
"NDC11Code": "24909-0180-50",
"ProductNDC": "24909-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Skin Repair",
"NonProprietaryName": "Calendula, Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170101",
"EndMarketingDate": "20260307",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "CALENDULA OFFICINALIS FLOWER; THUJA OCCIDENTALIS WHOLE",
"StrengthNumber": "1; 6",
"StrengthUnit": "[hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170101",
"EndMarketingDatePackage": "20251129",
"SamplePackage": "N",
"IndicationAndUsage": "Topical antiseptic helps decrease the risk of skin infection. Helps protect skin and supports healing of minor burns, skin lesions, sores, blisters, cracked or damaged skin and lips. Also helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "42576-180-50",
"PackageDescription": "510 g in 1 BOTTLE (42576-180-50)",
"NDC11Code": "42576-0180-50",
"ProductNDC": "42576-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 Nf",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206105",
"LabelerName": "NUVO PHARMACEUTICAL INC.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "49632-180-00",
"PackageDescription": "50 kg in 1 DRUM (49632-180-00) ",
"NDC11Code": "49632-0180-00",
"ProductNDC": "49632-180",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Econazole Nitrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151005",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "PMC Isochem",
"SubstanceName": "ECONAZOLE NITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-11-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-OCT-15"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>76385-180-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (76385-180-50) </PackageDescription>
<NDC11Code>76385-0180-50</NDC11Code>
<ProductNDC>76385-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>76385-180-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (76385-180-10) </PackageDescription>
<NDC11Code>76385-0180-10</NDC11Code>
<ProductNDC>76385-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>76385-180-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (76385-180-30) </PackageDescription>
<NDC11Code>76385-0180-30</NDC11Code>
<ProductNDC>76385-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>76385-180-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76385-180-90) </PackageDescription>
<NDC11Code>76385-0180-90</NDC11Code>
<ProductNDC>76385-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>76385-110-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-110-50) </PackageDescription>
<NDC11Code>76385-0110-50</NDC11Code>
<ProductNDC>76385-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</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>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>76385-111-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-50) </PackageDescription>
<NDC11Code>76385-0111-50</NDC11Code>
<ProductNDC>76385-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</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>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>76385-112-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-50) </PackageDescription>
<NDC11Code>76385-0112-50</NDC11Code>
<ProductNDC>76385-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</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>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>76385-113-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-113-50) </PackageDescription>
<NDC11Code>76385-0113-50</NDC11Code>
<ProductNDC>76385-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>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>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>76385-114-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-114-50) </PackageDescription>
<NDC11Code>76385-0114-50</NDC11Code>
<ProductNDC>76385-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207428</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-115-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-115-50) </PackageDescription>
<NDC11Code>76385-0115-50</NDC11Code>
<ProductNDC>76385-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207428</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-116-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-116-50) </PackageDescription>
<NDC11Code>76385-0116-50</NDC11Code>
<ProductNDC>76385-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207428</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-123-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76385-123-50) </PackageDescription>
<NDC11Code>76385-0123-50</NDC11Code>
<ProductNDC>76385-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>76385-124-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76385-124-50) </PackageDescription>
<NDC11Code>76385-0124-50</NDC11Code>
<ProductNDC>76385-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>76385-125-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-125-50) </PackageDescription>
<NDC11Code>76385-0125-50</NDC11Code>
<ProductNDC>76385-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Af</ProprietaryNameSuffix>
<NonProprietaryName>Sotalol Hydrochloride Tables Af</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207429</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-126-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-126-50) </PackageDescription>
<NDC11Code>76385-0126-50</NDC11Code>
<ProductNDC>76385-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Af</ProprietaryNameSuffix>
<NonProprietaryName>Sotalol Hydrochloride Tables Af</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207429</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-127-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50) </PackageDescription>
<NDC11Code>76385-0127-50</NDC11Code>
<ProductNDC>76385-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Af</ProprietaryNameSuffix>
<NonProprietaryName>Sotalol Hydrochloride Tablets Af</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207429</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol/Sotalol AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias (1.1) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2). Limitations of Use Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2).</IndicationAndUsage>
<Description>Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. Sotalol Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue #2 (aluminum lake 11% - 14%). Sotalol AF Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-128-50</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50) </PackageDescription>
<NDC11Code>76385-0128-50</NDC11Code>
<ProductNDC>76385-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207427</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate.System Components and Performance- Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
</NDC>
<NDC>
<NDCCode>76385-129-50</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-129-50) </PackageDescription>
<NDC11Code>76385-0129-50</NDC11Code>
<ProductNDC>76385-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207427</ApplicationNumber>
<LabelerName>UNICHEM PHARMACEUTICALS (USA), INC.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate.System Components and Performance- Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
</NDC>
<NDC>
<NDCCode>76385-142-05</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (76385-142-05) </PackageDescription>
<NDC11Code>76385-0142-05</NDC11Code>
<ProductNDC>76385-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chloroquine Phosphate</ProprietaryName>
<NonProprietaryName>Chloroquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090610</ApplicationNumber>
<LabelerName>Bayshore Pharmaceuticals LLC</LabelerName>
<SubstanceName>CHLOROQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale , and P.vivax.</IndicationAndUsage>
<Description>Chloroquine phosphate tablet, USP is a 4-aminoquinoline compound for oral administration. It is a white crystalline powder, odorless, has a bitter taste, and is discolored slowly on exposure to light. It is freely soluble in water, practically insoluble in alcohol, in chloroform and in ether. Chloroquine phosphate tablet, USP is an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula. C 18H 26CIN 3.2H 3PO 4 Molecular Weight: 515.86. Each tablet contains 250 mg of chloroquine phosphate USP, equivalent to 150 mg chloroquine base. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-144-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76385-144-50) </PackageDescription>
<NDC11Code>76385-0144-50</NDC11Code>
<ProductNDC>76385-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040766</ApplicationNumber>
<LabelerName>Bayshore Pharmaceuticals LLC</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum,Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate, USP is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, in chloroform, and in ether. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76385-178-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (76385-178-50) </PackageDescription>
<NDC11Code>76385-0178-50</NDC11Code>
<ProductNDC>76385-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>76385-179-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (76385-179-50) </PackageDescription>
<NDC11Code>76385-0179-50</NDC11Code>
<ProductNDC>76385-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210165</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260625</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>11489-180-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-180-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0180-01</NDC11Code>
<ProductNDC>11489-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Advanced Day Cream Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210809</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; 2.5; 3.75</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.</IndicationAndUsage>
<Description>No7 Protect & Perfect Intense ADVANCED Anti-Ageing Skincare System. Fine lines and wrinkles appear visibly reduced. Helps to protect from future signs of skin ageing. Younger looking skin in 2 weeks. 50 ml e 1.69 Fl. Oz. Day Cream. Advanded formula and all day hydration for visibly younger looking skin. Combining the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients, to reduce the appearance of the visible signs of ageing. The perfect partner to your No7 Protect & Perfect Intense ADVANCED serum, this day cream works to visibly reduce the appearance of fine lines and wrinkles in 4 weeks.</Description>
</NDC>
<NDC>
<NDCCode>11534-180-50</NDCCode>
<PackageDescription>510 g in 1 BOTTLE (11534-180-50) </PackageDescription>
<NDC11Code>11534-0180-50</NDC11Code>
<ProductNDC>11534-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 Nf</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206105</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13733-180-01</NDCCode>
<PackageDescription>50 mL in 1 CARTON (13733-180-01)</PackageDescription>
<NDC11Code>13733-0180-01</NDC11Code>
<ProductNDC>13733-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha M Perfect Cover Bb No 31</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide, Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Able C&C Co., Ltd.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>3.5; 2.09; 3.75</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13734-180-60</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13734-180-60) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>13734-0180-60</NDC11Code>
<ProductNDC>13734-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nars Pure Radiant Tinted Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Alaska</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>NARS Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>4.044; 3.996</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunbun. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-180-71</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-180-71) / 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0180-71</NDC11Code>
<ProductNDC>21130-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074661</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. minor pain of arthritis . muscular aches. backache. menstrual cramps. headache. toothache. the common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-180-50</NDCCode>
<PackageDescription>50 g in 1 TUBE (24909-180-50) </PackageDescription>
<NDC11Code>24909-0180-50</NDC11Code>
<ProductNDC>24909-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Skin Repair</ProprietaryName>
<NonProprietaryName>Calendula, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<EndMarketingDate>20260307</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWER; THUJA OCCIDENTALIS WHOLE</SubstanceName>
<StrengthNumber>1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251129</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical antiseptic helps decrease the risk of skin infection. Helps protect skin and supports healing of minor burns, skin lesions, sores, blisters, cracked or damaged skin and lips. Also helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42576-180-50</NDCCode>
<PackageDescription>510 g in 1 BOTTLE (42576-180-50)</PackageDescription>
<NDC11Code>42576-0180-50</NDC11Code>
<ProductNDC>42576-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 Nf</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206105</ApplicationNumber>
<LabelerName>NUVO PHARMACEUTICAL INC.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49632-180-00</NDCCode>
<PackageDescription>50 kg in 1 DRUM (49632-180-00) </PackageDescription>
<NDC11Code>49632-0180-00</NDC11Code>
<ProductNDC>49632-180</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Econazole Nitrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151005</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>PMC Isochem</LabelerName>
<SubstanceName>ECONAZOLE NITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-OCT-15</StartMarketingDatePackage>
</NDC>
</NDCList>