RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>13668-281-49</NDCCode>
    <PackageDescription>750 TABLET in 1 BOTTLE (13668-281-49) </PackageDescription>
    <NDC11Code>13668-0281-49</NDC11Code>
    <ProductNDC>13668-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazone Hcl And Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hcl And Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <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>68016-281-49</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (68016-281-49)  / 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68016-0281-49</NDC11Code>
    <ProductNDC>68016-281</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine Polacrilex</ProprietaryName>
    <ProprietaryNameSuffix>Coated Mint</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <RouteName>BUCCAL</RouteName>
    <StartMarketingDate>20130601</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078697</ApplicationNumber>
    <LabelerName>Chain Drug Consortium, LLC</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-003-49</NDCCode>
    <PackageDescription>750 TABLET, FILM COATED in 1 BOTTLE (13668-003-49)</PackageDescription>
    <NDC11Code>13668-0003-49</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>13668-271-49</NDCCode>
    <PackageDescription>750 TABLET, CHEWABLE in 1 BOTTLE (13668-271-49) </PackageDescription>
    <NDC11Code>13668-0271-49</NDC11Code>
    <ProductNDC>13668-271</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075712</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
    <Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 200 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Carbamazepine tablets, USP, 200 mg contain the inactive ingredients: colloidal silicon dioxide, FD&amp;C Red #40 aluminum lake, hypromellose, magnesium stearate, pregelatinized maize starch, corn starch, and sodium starch glycolate. Carbamazepine tablets, USP, (chewable) contain the inactive ingredients: artificial flavors, colloidal silicon dioxide, compressible sugar, corn starch, FD&amp;C Red #40 aluminum lake, hydroxypropyl methyl cellulose, magnesium stearate, and sodium starch glycolate. Carbamazepine tablets, USP, 200 mg meet USP Dissolution Test 2 and Carbamazepine Tablets USP (Chewable), 100 mg meet USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-310-49</NDCCode>
    <PackageDescription>750 CAPSULE in 1 BOTTLE (13668-310-49) </PackageDescription>
    <NDC11Code>13668-0310-49</NDC11Code>
    <ProductNDC>13668-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207677</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1   Osteoarthritis (OA) (1.1), 2   Rheumatoid Arthritis (RA) (1.2), 3   Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4   Ankylosing Spondylitis (AS) (1.4), 5   Acute Pain (AP) (1.5), 6   Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&amp;C blue 1 and FD&amp;C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&amp;C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-281-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-281-05) </PackageDescription>
    <NDC11Code>13668-0281-05</NDC11Code>
    <ProductNDC>13668-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazone Hcl And Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hcl And Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <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>13668-281-33</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (13668-281-33) </PackageDescription>
    <NDC11Code>13668-0281-33</NDC11Code>
    <ProductNDC>13668-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazone Hcl And Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hcl And Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <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>13668-281-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (13668-281-60) </PackageDescription>
    <NDC11Code>13668-0281-60</NDC11Code>
    <ProductNDC>13668-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazone Hcl And Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hcl And Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <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>13668-281-74</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (13668-281-74) </PackageDescription>
    <NDC11Code>13668-0281-74</NDC11Code>
    <ProductNDC>13668-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pioglitazone Hcl And Metformin Hcl</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hcl And Metformin Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250901</StartMarketingDate>
    <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>47335-303-15</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (47335-303-15) </PackageDescription>
    <NDC11Code>47335-0303-15</NDC11Code>
    <ProductNDC>47335-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Odomzo</ProprietaryName>
    <NonProprietaryName>Sonidegib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205266</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>SONIDEGIB PHOSPHATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.</IndicationAndUsage>
    <Description>Sonidegib is a Hh pathway inhibitor. The molecular formula for sonidegib phosphate is C26H26 F3N3O3 2H3PO4. The molecular weight is 681.49 daltons. The chemical name is N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-biphenyl]-3-carboxamide diphosphate. The molecular structure is shown below. Sonidegib phosphate is a white to off-white powder. Sonidegib freebase is practically insoluble. ODOMZO (sonidegib) capsules for oral use contain 200 mg of sonidegib as the freebase (equivalent to 281 mg of diphosphate salt of sonidegib) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer and sodium lauryl sulfate. The opaque pink hard gelatin capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>47335-303-83</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (47335-303-83) </PackageDescription>
    <NDC11Code>47335-0303-83</NDC11Code>
    <ProductNDC>47335-303</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Odomzo</ProprietaryName>
    <NonProprietaryName>Sonidegib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205266</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>SONIDEGIB PHOSPHATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.</IndicationAndUsage>
    <Description>Sonidegib is a Hh pathway inhibitor. The molecular formula for sonidegib phosphate is C26H26 F3N3O3 2H3PO4. The molecular weight is 681.49 daltons. The chemical name is N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-biphenyl]-3-carboxamide diphosphate. The molecular structure is shown below. Sonidegib phosphate is a white to off-white powder. Sonidegib freebase is practically insoluble. ODOMZO (sonidegib) capsules for oral use contain 200 mg of sonidegib as the freebase (equivalent to 281 mg of diphosphate salt of sonidegib) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer and sodium lauryl sulfate. The opaque pink hard gelatin capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-281-03</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-03) </PackageDescription>
    <NDC11Code>65162-0281-03</NDC11Code>
    <ProductNDC>65162-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204707</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone, USP contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Inactive ingredients are colloidal silicon dioxide, fumaric acid, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene oxides, povidone, talc and triethyl citrate. The 1.5 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. The 6 mg tablets also contain iron oxide red and iron oxide yellow. The 9 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. Delivery System Components and Performance. Paliperidone extended-release tablets use a hydrophilic matrix core and pH dependent enteric coating to deliver paliperidone, USP at a controlled rate. The delivery system consists of an inner core composed of the drug, rate controlling polymers and other excipients. The core is coated with multiple layers comprising of delayed release polymer and a drug layering polymer system. Each tablet strength has a different colored coating. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible overcoat erodes quickly. The combination of the coating layers ensures an initial drug release, while delaying exposure of the matrix core. Upon attaining the intended pH, the delayed release coating dissolves, the hydrophilic polymers of the core hydrate and swell forming a gel like barrier that regulates the rate at which the drug is released from the tablet, ensuring a steady and prolonged delivery.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-281-09</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-09) </PackageDescription>
    <NDC11Code>65162-0281-09</NDC11Code>
    <ProductNDC>65162-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204707</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone, USP contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Inactive ingredients are colloidal silicon dioxide, fumaric acid, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene oxides, povidone, talc and triethyl citrate. The 1.5 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. The 6 mg tablets also contain iron oxide red and iron oxide yellow. The 9 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. Delivery System Components and Performance. Paliperidone extended-release tablets use a hydrophilic matrix core and pH dependent enteric coating to deliver paliperidone, USP at a controlled rate. The delivery system consists of an inner core composed of the drug, rate controlling polymers and other excipients. The core is coated with multiple layers comprising of delayed release polymer and a drug layering polymer system. Each tablet strength has a different colored coating. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible overcoat erodes quickly. The combination of the coating layers ensures an initial drug release, while delaying exposure of the matrix core. Upon attaining the intended pH, the delayed release coating dissolves, the hydrophilic polymers of the core hydrate and swell forming a gel like barrier that regulates the rate at which the drug is released from the tablet, ensuring a steady and prolonged delivery.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-281-32</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-281-32)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>68462-0281-32</NDC11Code>
    <ProductNDC>68462-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate/timolol Maleate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240516</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214987</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240516</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
    <Description>Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-281-69</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-281-69)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>68462-0281-69</NDC11Code>
    <ProductNDC>68462-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate/timolol Maleate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240516</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214987</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240516</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
    <Description>Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-281-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-281-18) </PackageDescription>
    <NDC11Code>72205-0281-18</NDC11Code>
    <ProductNDC>72205-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250716</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213748</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C48H55N6O8Na3 Its molecular mass is 912.96 g/mol  and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>72205-281-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-281-60) </PackageDescription>
    <NDC11Code>72205-0281-60</NDC11Code>
    <ProductNDC>72205-281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250716</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213748</ApplicationNumber>
    <LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C48H55N6O8Na3 Its molecular mass is 912.96 g/mol  and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-035-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-035-01) </PackageDescription>
    <NDC11Code>13668-0035-01</NDC11Code>
    <ProductNDC>13668-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-035-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-035-05) </PackageDescription>
    <NDC11Code>13668-0035-05</NDC11Code>
    <ProductNDC>13668-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-035-09</NDCCode>
    <PackageDescription>9990 TABLET in 1 BOTTLE (13668-035-09) </PackageDescription>
    <NDC11Code>13668-0035-09</NDC11Code>
    <ProductNDC>13668-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-035-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13668-035-30) </PackageDescription>
    <NDC11Code>13668-0035-30</NDC11Code>
    <ProductNDC>13668-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-035-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (13668-035-60) </PackageDescription>
    <NDC11Code>13668-0035-60</NDC11Code>
    <ProductNDC>13668-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-036-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-036-01) </PackageDescription>
    <NDC11Code>13668-0036-01</NDC11Code>
    <ProductNDC>13668-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-036-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-036-05) </PackageDescription>
    <NDC11Code>13668-0036-05</NDC11Code>
    <ProductNDC>13668-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-036-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13668-036-30) </PackageDescription>
    <NDC11Code>13668-0036-30</NDC11Code>
    <ProductNDC>13668-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-036-54</NDCCode>
    <PackageDescription>8500 TABLET in 1 BOTTLE (13668-036-54) </PackageDescription>
    <NDC11Code>13668-0036-54</NDC11Code>
    <ProductNDC>13668-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-036-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (13668-036-60) </PackageDescription>
    <NDC11Code>13668-0036-60</NDC11Code>
    <ProductNDC>13668-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Risperidone</NonProprietaryName>
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    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-037-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-037-01) </PackageDescription>
    <NDC11Code>13668-0037-01</NDC11Code>
    <ProductNDC>13668-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-037-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-037-05) </PackageDescription>
    <NDC11Code>13668-0037-05</NDC11Code>
    <ProductNDC>13668-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-037-55</NDCCode>
    <PackageDescription>4200 TABLET in 1 BOTTLE (13668-037-55) </PackageDescription>
    <NDC11Code>13668-0037-55</NDC11Code>
    <ProductNDC>13668-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079088</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1   Treatment of schizophrenia (1.1), 2   As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder  (1.2), 3   Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone tablets, USP, contain risperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (yellow), 0.5 mg (red), 1 mg (white to off white), 2 mg (Light orange), 3 mg (yellow), and 4 mg (yellow) strengths. Risperidone tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide and additional colorants listed below. 0.25, 3 and 4 mg tablets: Ferric oxide yellow. 0.5 mg tablets: Ferric oxide red. 2 mg tablets: FD&amp;C yellow # 6 Orange yellow S (E 110).</Description>
  </NDC>
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