{
"NDC": [
{
"NDCCode": "13668-281-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-281-05) ",
"NDC11Code": "13668-0281-05",
"ProductNDC": "13668-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"NonProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202001",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], 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": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).",
"Description": "Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "13668-281-33",
"PackageDescription": "180 TABLET in 1 BOTTLE (13668-281-33) ",
"NDC11Code": "13668-0281-33",
"ProductNDC": "13668-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"NonProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202001",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], 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": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).",
"Description": "Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "13668-281-49",
"PackageDescription": "750 TABLET in 1 BOTTLE (13668-281-49) ",
"NDC11Code": "13668-0281-49",
"ProductNDC": "13668-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"NonProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202001",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], 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": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).",
"Description": "Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "13668-281-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (13668-281-60) ",
"NDC11Code": "13668-0281-60",
"ProductNDC": "13668-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"NonProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202001",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], 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": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).",
"Description": "Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "13668-281-74",
"PackageDescription": "100 TABLET in 1 CARTON (13668-281-74) ",
"NDC11Code": "13668-0281-74",
"ProductNDC": "13668-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"NonProprietaryName": "Pioglitazone Hcl And Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202001",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], 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": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).",
"Description": "Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "31722-281-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-281-05)",
"NDC11Code": "31722-0281-05",
"ProductNDC": "31722-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1)., 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets."
},
{
"NDCCode": "53489-281-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (53489-281-05) ",
"NDC11Code": "53489-0281-05",
"ProductNDC": "53489-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergoloid Mesylates",
"NonProprietaryName": "Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081113",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE",
"StrengthNumber": ".222; .111; .333; .333",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "A proportion of individuals over sixty who manifest signs and symptoms of an idiopathic decline in mental capacity (i.e., cognitive and interpersonal skills, mood, self-care, apparent motivation) can experience some symptomatic relief upon treatment with ergoloid mesylates preparations. The identity of the specific trait(s) or condition(s), if any, which would usefully predict a response to ergoloid mesylates therapy is not known. It appears, however, that those individuals who do respond come from groups of patients who would be considered clinically to suffer from some ill-defined process related to aging or to have some underlying dementing condition (i.e., primary progressive dementia, Alzheimer's dementia, senile onset, multi-infarct dementia). Before prescribing ergoloid mesylates, the physician should exclude the possibility that the patient's signs and symptoms arise from a potentially reversible and treatable condition. Particular care should be taken to exclude delirium and dementiform illness secondary to systemic disease, primary neurological disease, or primary disturbance of mood. Ergoloid mesylates preparations are not indicated in the treatment of acute or chronic psychosis, regardless of etiology (see CONTRAINDICATIONS). The decision to use ergoloid mesylates in the treatment of an individual with a symptomatic decline in mental capacity of unknown etiology should be continually reviewed since the presenting clinical picture may subsequently evolve sufficiently to allow a specific diagnosis and a specific alternative treatment. In addition, continued clinical evaluation is required to determine whether any initial benefit conferred by ergoloid mesylates therapy persists with time. The efficacy of ergoloid mesylates was evaluated using a special rating scale known as the SCAG (Sandoz Clinical Assessment-Geriatric). The specific items on this scale on which modest but statistically significant changes were observed at the end of twelve weeks include: mental alertness, confusion, recent memory, orientation, emotional lability, self-care, depression, anxiety/fears, cooperation, sociability, appetite, dizziness, fatigue, bothersome(ness), and an overall impression of clinical status.",
"Description": "Each tablet for oral use contains ergoloid mesylates USP; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids. C31H41N5O5 CH4O3S (dihydroergocornine mesylate) 659.79. C35H41N5O5 CH4O3S (dihydroergocristine mesylate) 707.84. C32H43N5O5 CH4O3S (dihydro-α-ergocryptine mesylate) 673.82. C32H43N5O5 CH4O3S (dihydro-β-ergocryptine mesylate) 673.82. Inactive ingredients for oral tablets are: butylated hydroxyanisol, corn starch, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrolidone, stearic acid and talc."
},
{
"NDCCode": "55111-281-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-281-05) ",
"NDC11Code": "55111-0281-05",
"ProductNDC": "55111-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076710",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110620",
"SamplePackage": "N",
"Description": "Levofloxacin tablets are synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients:. : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. , 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, synthetic yellow iron oxide and titanium dioxide."
},
{
"NDCCode": "59746-281-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-281-05) ",
"NDC11Code": "59746-0281-05",
"ProductNDC": "59746-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202280",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram is indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.",
"Description": "Escitalopram tablets USP contains escitalopram oxalate USP an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate USP is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate USP occurs as white to almost white crystalline powder and is soluble in methanol. Escitalopram tablets USP are film-coated, containing escitalopram oxalate USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of, escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating contains polyethylene glycol, hypromellose, and titanium dioxide."
},
{
"NDCCode": "63552-281-00",
"PackageDescription": "208 VIAL in 1 CASE (63552-281-00) / .05 mL in 1 VIAL",
"NDC11Code": "63552-0281-00",
"ProductNDC": "63552-281",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aflibercept-jbvf",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "AFLIBERCEPT-JBVF",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20-MAY-24"
},
{
"NDCCode": "64980-281-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-05) ",
"NDC11Code": "64980-0281-05",
"ProductNDC": "64980-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204720",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"Description": "Glipizide extended-release tablets,USP contain glipizide which is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each extended-release film-coated tablet contains 2.63 mg glipizide, USP to provide a 2.5 mg dose.Each extended-release film-coated tablet contains 5.25 mg glipizide, USP to provide a 5 mg dose.Each extended-release film-coated tablet contains 10.50 mg glipizide, USP to provide a 10 mg dose. Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: cellulose acetate, ferrosoferric oxide, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, red ferric oxide, shellac, sodium chloride, titanium dioxide. The 2.5 mg tablet also contains: FD&C blue#2, lactose monohydrate and triacetin. System Components and PerformanceGlipizide extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.The function of the glipizide extended-release tablets depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell."
},
{
"NDCCode": "65219-281-15",
"PackageDescription": "2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) ",
"NDC11Code": "65219-0281-15",
"ProductNDC": "65219-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadobutrol",
"NonProprietaryName": "Gadobutrol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215061",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GADOBUTROL",
"StrengthNumber": "604.72",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): 1 To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (1.1), 2 To assess the presence and extent of malignant breast disease in adult patients (1.2), 3 To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (1.3), 4 To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). (1.4).",
"Description": "Gadobutrol injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72. Gadobutrol injection is a sterile, clear, colorless to pale yellow solution containing 604.72 mg (1.0 mmol) of gadobutrol per mL as the active ingredient with 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadobutrol injection contains no preservatives. The main physicochemical properties of gadobutrol injection (1 mmol/mL solution for injection) are listed below. The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively."
},
{
"NDCCode": "68428-281-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-281-05) ",
"NDC11Code": "68428-0281-05",
"ProductNDC": "68428-281",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calotropis Gigantea",
"NonProprietaryName": "Calotropis Gigantea Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100324",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALOTROPIS GIGANTEA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100324",
"SamplePackage": "N"
},
{
"NDCCode": "75936-281-05",
"PackageDescription": "1.5 mL in 1 PACKET (75936-281-05) ",
"NDC11Code": "75936-0281-05",
"ProductNDC": "75936-281",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Mattescreen Spf 40",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210518",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "1.3; 17.4",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210518",
"SamplePackage": "Y",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs. ."
},
{
"NDCCode": "84756-281-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-281-05) ",
"NDC11Code": "84756-0281-05",
"ProductNDC": "84756-281",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roseship Oil Certified Organic",
"NonProprietaryName": "Roseship Oil Certified Organic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "13668-001-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-001-05)",
"NDC11Code": "13668-0001-05",
"ProductNDC": "13668-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077711",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "13668-002-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-002-05)",
"NDC11Code": "13668-0002-05",
"ProductNDC": "13668-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077711",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "13668-003-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-003-05)",
"NDC11Code": "13668-0003-05",
"ProductNDC": "13668-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077711",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "13668-004-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-004-05) ",
"NDC11Code": "13668-0004-05",
"ProductNDC": "13668-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077765",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140925",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "13668-005-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-005-05) ",
"NDC11Code": "13668-0005-05",
"ProductNDC": "13668-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077765",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140925",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "13668-006-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-006-05) ",
"NDC11Code": "13668-0006-05",
"ProductNDC": "13668-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077765",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140925",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "13668-007-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-007-05) ",
"NDC11Code": "13668-0007-05",
"ProductNDC": "13668-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
"Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
},
{
"NDCCode": "13668-008-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-008-05) ",
"NDC11Code": "13668-0008-05",
"ProductNDC": "13668-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
"Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
},
{
"NDCCode": "13668-009-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-009-05) ",
"NDC11Code": "13668-0009-05",
"ProductNDC": "13668-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071018",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "13668-010-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (13668-010-05) ",
"NDC11Code": "13668-0010-05",
"ProductNDC": "13668-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071018",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
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"RouteName": "ORAL",
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"LabelerName": "Torrent Pharmaceuticals Limited",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
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"LabelerName": "Torrent Pharmaceuticals Limited",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Torrent Pharmaceuticals Limited",
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{
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"PackageDescription": "500 TABLET in 1 BOTTLE (13668-014-05) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA078858",
"LabelerName": "Torrent Pharmaceuticals Limited",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078858",
"LabelerName": "Torrent Pharmaceuticals Limited",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3."
}
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<Description>Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202001</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], 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>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Limitations of Use:Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. (1).</IndicationAndUsage>
<Description>Pioglitazone and metformin hydrochloride tablets, USP are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone HCl and metformin HCl. 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 HCl, USP is an odorless white crystalline powder that has a molecular formula of C 19H 20N 2O 3SHCl 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. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl), USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.62. Metformin HCl 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 HCl is 6.68. The structural formula is as shown. Pioglitazone and metformin hydrochloride tablets, USP are available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-281-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-281-05)</PackageDescription>
<NDC11Code>31722-0281-05</NDC11Code>
<ProductNDC>31722-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1)., 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>53489-281-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (53489-281-05) </PackageDescription>
<NDC11Code>53489-0281-05</NDC11Code>
<ProductNDC>53489-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergoloid Mesylates</ProprietaryName>
<NonProprietaryName>Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081113</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE</SubstanceName>
<StrengthNumber>.222; .111; .333; .333</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>A proportion of individuals over sixty who manifest signs and symptoms of an idiopathic decline in mental capacity (i.e., cognitive and interpersonal skills, mood, self-care, apparent motivation) can experience some symptomatic relief upon treatment with ergoloid mesylates preparations. The identity of the specific trait(s) or condition(s), if any, which would usefully predict a response to ergoloid mesylates therapy is not known. It appears, however, that those individuals who do respond come from groups of patients who would be considered clinically to suffer from some ill-defined process related to aging or to have some underlying dementing condition (i.e., primary progressive dementia, Alzheimer's dementia, senile onset, multi-infarct dementia). Before prescribing ergoloid mesylates, the physician should exclude the possibility that the patient's signs and symptoms arise from a potentially reversible and treatable condition. Particular care should be taken to exclude delirium and dementiform illness secondary to systemic disease, primary neurological disease, or primary disturbance of mood. Ergoloid mesylates preparations are not indicated in the treatment of acute or chronic psychosis, regardless of etiology (see CONTRAINDICATIONS). The decision to use ergoloid mesylates in the treatment of an individual with a symptomatic decline in mental capacity of unknown etiology should be continually reviewed since the presenting clinical picture may subsequently evolve sufficiently to allow a specific diagnosis and a specific alternative treatment. In addition, continued clinical evaluation is required to determine whether any initial benefit conferred by ergoloid mesylates therapy persists with time. The efficacy of ergoloid mesylates was evaluated using a special rating scale known as the SCAG (Sandoz Clinical Assessment-Geriatric). The specific items on this scale on which modest but statistically significant changes were observed at the end of twelve weeks include: mental alertness, confusion, recent memory, orientation, emotional lability, self-care, depression, anxiety/fears, cooperation, sociability, appetite, dizziness, fatigue, bothersome(ness), and an overall impression of clinical status.</IndicationAndUsage>
<Description>Each tablet for oral use contains ergoloid mesylates USP; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids. C31H41N5O5 CH4O3S (dihydroergocornine mesylate) 659.79. C35H41N5O5 CH4O3S (dihydroergocristine mesylate) 707.84. C32H43N5O5 CH4O3S (dihydro-α-ergocryptine mesylate) 673.82. C32H43N5O5 CH4O3S (dihydro-β-ergocryptine mesylate) 673.82. Inactive ingredients for oral tablets are: butylated hydroxyanisol, corn starch, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrolidone, stearic acid and talc.</Description>
</NDC>
<NDC>
<NDCCode>55111-281-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-281-05) </PackageDescription>
<NDC11Code>55111-0281-05</NDC11Code>
<ProductNDC>55111-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076710</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levofloxacin tablets are synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients:. : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. , 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, synthetic yellow iron oxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-281-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-281-05) </PackageDescription>
<NDC11Code>59746-0281-05</NDC11Code>
<ProductNDC>59746-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202280</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram is indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.</IndicationAndUsage>
<Description>Escitalopram tablets USP contains escitalopram oxalate USP an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate USP is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate USP occurs as white to almost white crystalline powder and is soluble in methanol. Escitalopram tablets USP are film-coated, containing escitalopram oxalate USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of, escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating contains polyethylene glycol, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63552-281-00</NDCCode>
<PackageDescription>208 VIAL in 1 CASE (63552-281-00) / .05 mL in 1 VIAL</PackageDescription>
<NDC11Code>63552-0281-00</NDC11Code>
<ProductNDC>63552-281</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aflibercept-jbvf</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Manufacturing Services LLC</LabelerName>
<SubstanceName>AFLIBERCEPT-JBVF</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-MAY-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64980-281-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-05) </PackageDescription>
<NDC11Code>64980-0281-05</NDC11Code>
<ProductNDC>64980-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204720</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Glipizide extended-release tablets,USP contain glipizide which is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each extended-release film-coated tablet contains 2.63 mg glipizide, USP to provide a 2.5 mg dose.Each extended-release film-coated tablet contains 5.25 mg glipizide, USP to provide a 5 mg dose.Each extended-release film-coated tablet contains 10.50 mg glipizide, USP to provide a 10 mg dose. Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: cellulose acetate, ferrosoferric oxide, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, red ferric oxide, shellac, sodium chloride, titanium dioxide. The 2.5 mg tablet also contains: FD&C blue#2, lactose monohydrate and triacetin. System Components and PerformanceGlipizide extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.The function of the glipizide extended-release tablets depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.</Description>
</NDC>
<NDC>
<NDCCode>65219-281-15</NDCCode>
<PackageDescription>2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) </PackageDescription>
<NDC11Code>65219-0281-15</NDC11Code>
<ProductNDC>65219-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadobutrol</ProprietaryName>
<NonProprietaryName>Gadobutrol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215061</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GADOBUTROL</SubstanceName>
<StrengthNumber>604.72</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): 1 To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (1.1), 2 To assess the presence and extent of malignant breast disease in adult patients (1.2), 3 To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (1.3), 4 To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). (1.4).</IndicationAndUsage>
<Description>Gadobutrol injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72. Gadobutrol injection is a sterile, clear, colorless to pale yellow solution containing 604.72 mg (1.0 mmol) of gadobutrol per mL as the active ingredient with 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadobutrol injection contains no preservatives. The main physicochemical properties of gadobutrol injection (1 mmol/mL solution for injection) are listed below. The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>68428-281-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-281-05) </PackageDescription>
<NDC11Code>68428-0281-05</NDC11Code>
<ProductNDC>68428-281</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calotropis Gigantea</ProprietaryName>
<NonProprietaryName>Calotropis Gigantea Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALOTROPIS GIGANTEA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75936-281-05</NDCCode>
<PackageDescription>1.5 mL in 1 PACKET (75936-281-05) </PackageDescription>
<NDC11Code>75936-0281-05</NDC11Code>
<ProductNDC>75936-281</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Mattescreen Spf 40</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.3; 17.4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210518</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-281-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-281-05) </PackageDescription>
<NDC11Code>84756-0281-05</NDC11Code>
<ProductNDC>84756-281</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Roseship Oil Certified Organic</ProprietaryName>
<NonProprietaryName>Roseship Oil Certified Organic</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-001-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-001-05)</PackageDescription>
<NDC11Code>13668-0001-05</NDC11Code>
<ProductNDC>13668-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077711</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-002-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-002-05)</PackageDescription>
<NDC11Code>13668-0002-05</NDC11Code>
<ProductNDC>13668-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077711</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-003-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-003-05)</PackageDescription>
<NDC11Code>13668-0003-05</NDC11Code>
<ProductNDC>13668-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077711</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-004-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-004-05) </PackageDescription>
<NDC11Code>13668-0004-05</NDC11Code>
<ProductNDC>13668-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077765</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140925</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-005-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-005-05) </PackageDescription>
<NDC11Code>13668-0005-05</NDC11Code>
<ProductNDC>13668-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077765</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140925</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-006-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-006-05) </PackageDescription>
<NDC11Code>13668-0006-05</NDC11Code>
<ProductNDC>13668-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077765</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140925</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-007-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-007-05) </PackageDescription>
<NDC11Code>13668-0007-05</NDC11Code>
<ProductNDC>13668-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
<Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>13668-008-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-008-05) </PackageDescription>
<NDC11Code>13668-0008-05</NDC11Code>
<ProductNDC>13668-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
<Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>13668-009-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-009-05) </PackageDescription>
<NDC11Code>13668-0009-05</NDC11Code>
<ProductNDC>13668-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13668-010-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-010-05) </PackageDescription>
<NDC11Code>13668-0010-05</NDC11Code>
<ProductNDC>13668-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13668-011-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13668-011-05) </PackageDescription>
<NDC11Code>13668-0011-05</NDC11Code>
<ProductNDC>13668-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13668-012-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-012-05) </PackageDescription>
<NDC11Code>13668-0012-05</NDC11Code>
<ProductNDC>13668-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090014</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-013-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-013-05) </PackageDescription>
<NDC11Code>13668-0013-05</NDC11Code>
<ProductNDC>13668-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079226</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-014-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-014-05) </PackageDescription>
<NDC11Code>13668-0014-05</NDC11Code>
<ProductNDC>13668-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078858</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>13668-015-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-015-05) </PackageDescription>
<NDC11Code>13668-0015-05</NDC11Code>
<ProductNDC>13668-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078858</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
</NDCList>