RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>51013-426-48</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (51013-426-48)  &gt; 10 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>51013-0426-48</NDC11Code>
    <ProductNDC>51013-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stool Softener</ProprietaryName>
    <NonProprietaryName>Docusate Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>PuraCap Pharmaceutical LLC</LabelerName>
    <SubstanceName>DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0378-0630-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0378-0630-01) </PackageDescription>
    <NDC11Code>00378-0630-01</NDC11Code>
    <ProductNDC>0378-0630</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0630-88</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (0378-0630-88)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00378-0630-88</NDC11Code>
    <ProductNDC>0378-0630</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0630-91</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0378-0630-91) </PackageDescription>
    <NDC11Code>00378-0630-91</NDC11Code>
    <ProductNDC>0378-0630</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0631-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0378-0631-01) </PackageDescription>
    <NDC11Code>00378-0631-01</NDC11Code>
    <ProductNDC>0378-0631</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0631-88</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (0378-0631-88)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00378-0631-88</NDC11Code>
    <ProductNDC>0378-0631</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0631-91</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0378-0631-91) </PackageDescription>
    <NDC11Code>00378-0631-91</NDC11Code>
    <ProductNDC>0378-0631</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0632-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0378-0632-01) </PackageDescription>
    <NDC11Code>00378-0632-01</NDC11Code>
    <ProductNDC>0378-0632</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0632-88</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (0378-0632-88)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00378-0632-88</NDC11Code>
    <ProductNDC>0378-0632</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0632-91</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0378-0632-91) </PackageDescription>
    <NDC11Code>00378-0632-91</NDC11Code>
    <ProductNDC>0378-0632</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0633-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0378-0633-01) </PackageDescription>
    <NDC11Code>00378-0633-01</NDC11Code>
    <ProductNDC>0378-0633</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0636-91</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0378-0636-91) </PackageDescription>
    <NDC11Code>00378-0636-91</NDC11Code>
    <ProductNDC>0378-0636</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iloperidone</ProprietaryName>
    <NonProprietaryName>Iloperidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207231</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ILOPERIDONE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
    <Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3693-19</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-19) </PackageDescription>
    <NDC11Code>00591-3693-19</NDC11Code>
    <ProductNDC>0591-3693</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3693-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3693-30) </PackageDescription>
    <NDC11Code>00591-3693-30</NDC11Code>
    <ProductNDC>0591-3693</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3694-19</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-19) </PackageDescription>
    <NDC11Code>00591-3694-19</NDC11Code>
    <ProductNDC>0591-3694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3694-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-30) </PackageDescription>
    <NDC11Code>00591-3694-30</NDC11Code>
    <ProductNDC>0591-3694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3695-19</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3695-19) </PackageDescription>
    <NDC11Code>00591-3695-19</NDC11Code>
    <ProductNDC>0591-3695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-3695-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3695-30) </PackageDescription>
    <NDC11Code>00591-3695-30</NDC11Code>
    <ProductNDC>0591-3695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
    <Description>Paliperidone USP, the active ingredient in paliperidone extended-release tablets, is 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 426.48. 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 (beige), 3 mg (white to off-white), 6 mg (reddish-brown), and 9 mg (blue) strengths. Inactive ingredients are ammonium hydroxide, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&amp;C Red # 40 Aluminum Lake HT, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, polyethylene glycol 3350, polyethylene oxide, povidone, propylene glycol, shellac glaze, sodium chloride, stearic acid and titanium dioxide. The 1.5 mg tablets also contain iron oxide yellow, iron oxide red, polyvinyl alcohol and talc. The 3 mg tablets also contain lactose monohydrate and triacetin. The 6 mg tablets also contain iron oxide red, polyvinyl alcohol and talc. The 9 mg tablets also contain FD&amp;C Blue # 2 Aluminum Lake, polydextrose, polyethylene glycol 8000, and triacetin. Delivery System Components and Performance. Paliperidone extended-release tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>27241-276-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-276-30) </PackageDescription>
    <NDC11Code>27241-0276-30</NDC11Code>
    <ProductNDC>27241-276</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218514</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) , 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) .</IndicationAndUsage>
    <Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain 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 426.48. The structural formula is. Paliperidone is sparingly soluble in 0.1 N HCl and in methylene chloride practically insoluble in water, in 0.1N NaOH, and in hexane and slightly soluble in N,N-dimethyl formamide and in tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off-white), 6 mg (yellow), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are polyethylene oxide, microcrystalline cellulose, povidone, butylated hydroxytoluene, colloidal silicone dioxide, magnesium stearate, sodium chloride, ferric oxide, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol. Film coating contains hypromellose, titanium dioxide, and for 1.5 mg polyethylene glycol/macrogol MW 400, iron oxide yellow, iron oxide red. For 3 mg polyethylene glycol/macrogol MW 400. for 6 mg polyethylene glycol/macrogol 8000, talc, iron oxide yellow, black iron oxide. for 9 mg polyethylene glycol/macrogol MW 400, iron oxide yellow, iron oxide red. For imprinting, ink contains shellac glaze, propylene glycol and black iron oxide. Delivery System Components and Performance Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of one drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
  <NDC>
    <NDCCode>27241-277-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-277-30) </PackageDescription>
    <NDC11Code>27241-0277-30</NDC11Code>
    <ProductNDC>27241-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218514</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) , 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) .</IndicationAndUsage>
    <Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain 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 426.48. The structural formula is. Paliperidone is sparingly soluble in 0.1 N HCl and in methylene chloride practically insoluble in water, in 0.1N NaOH, and in hexane and slightly soluble in N,N-dimethyl formamide and in tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off-white), 6 mg (yellow), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are polyethylene oxide, microcrystalline cellulose, povidone, butylated hydroxytoluene, colloidal silicone dioxide, magnesium stearate, sodium chloride, ferric oxide, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol. Film coating contains hypromellose, titanium dioxide, and for 1.5 mg polyethylene glycol/macrogol MW 400, iron oxide yellow, iron oxide red. For 3 mg polyethylene glycol/macrogol MW 400. for 6 mg polyethylene glycol/macrogol 8000, talc, iron oxide yellow, black iron oxide. for 9 mg polyethylene glycol/macrogol MW 400, iron oxide yellow, iron oxide red. For imprinting, ink contains shellac glaze, propylene glycol and black iron oxide. Delivery System Components and Performance Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of one drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is one precision laser-drilled orifice on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
  </NDC>
</NDCList>