RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68428-426-06</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-426-06) </PackageDescription>
    <NDC11Code>68428-0426-06</NDC11Code>
    <ProductNDC>68428-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaminum Hydrocloricum</ProprietaryName>
    <NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>22557-001-06</NDCCode>
    <PackageDescription>426 L in 1 CYLINDER (22557-001-06) </PackageDescription>
    <NDC11Code>22557-0001-06</NDC11Code>
    <ProductNDC>22557-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20020101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205840</ApplicationNumber>
    <LabelerName>AGP LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>46911-001-06</NDCCode>
    <PackageDescription>426 L in 1 CYLINDER (46911-001-06)</PackageDescription>
    <NDC11Code>46911-0001-06</NDC11Code>
    <ProductNDC>46911-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19920101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>H &amp; C Oxygen, Inc.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68382-426-06</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-426-06) </PackageDescription>
    <NDC11Code>68382-0426-06</NDC11Code>
    <ProductNDC>68382-426</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207762</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>2.5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and atorvastatin tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine is indicated for the treatment of Coronary Artery Disease (1.2). Atorvastatin is indicated as an adjunct therapy to diet for prevention of cardiovascular disease (1.3) and hyperlipidemia (1.4).</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro- 6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl- 4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its molecular formula is (C33H34 FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine besylate, USP is white or almost white powder that is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Amlodipine besylate has a molecular weight of 567.05. Atorvastatin calcium, USP is a white to off-white crystalline powder and has a molecular weight of 1,209.42 It is freely soluble in methanol, slightly soluble in alcohol, very slightly soluble in distilled water, in pH 7.4 phosphate buffer, insoluble in aqueous solution of pH 4 and below. Each film-coated amlodipine and atorvastatin tablet, USP contains combination of amlodipine besylate, USP equivalent to amlodipine 2.5, 5, or 10 mg and atorvastatin calcium, USP equivalent to atorvastatin 10, 20, 40, or 80 mg and also contains following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinised starch, polysorbate 80, titanium dioxide and talc. Additionally 10 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg also contains FD&amp;C blue #2 aluminum lake. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-426-03</NDCCode>
    <PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-426-03) </PackageDescription>
    <NDC11Code>68428-0426-03</NDC11Code>
    <ProductNDC>68428-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaminum Hydrocloricum</ProprietaryName>
    <NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-426-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-426-05) </PackageDescription>
    <NDC11Code>68428-0426-05</NDC11Code>
    <ProductNDC>68428-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaminum Hydrocloricum</ProprietaryName>
    <NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-426-11</NDCCode>
    <PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-426-11) </PackageDescription>
    <NDC11Code>68428-0426-11</NDC11Code>
    <ProductNDC>68428-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaminum Hydrocloricum</ProprietaryName>
    <NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-426-12</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-426-12) </PackageDescription>
    <NDC11Code>68428-0426-12</NDC11Code>
    <ProductNDC>68428-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Histaminum Hydrocloricum</ProprietaryName>
    <NonProprietaryName>Histamine Dihydrochloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HISTAMINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0006-5028-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0006-5028-06)  / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-05) </PackageDescription>
    <NDC11Code>00006-5028-06</NDC11Code>
    <ProductNDC>0006-5028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verquvo</ProprietaryName>
    <NonProprietaryName>Vericiguat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214377</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>VERICIGUAT</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230401</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C19H16F2N8O2 and the molecular weight is 426.39 g/mol. The chemical structure is. Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat.The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-5029-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0006-5029-06)  / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05) </PackageDescription>
    <NDC11Code>00006-5029-06</NDC11Code>
    <ProductNDC>0006-5029</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verquvo</ProprietaryName>
    <NonProprietaryName>Vericiguat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214377</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>VERICIGUAT</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C19H16F2N8O2 and the molecular weight is 426.39 g/mol. The chemical structure is. Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat.The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0467-91</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (0078-0467-91)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0078-0467-61) </PackageDescription>
    <NDC11Code>00078-0467-91</NDC11Code>
    <ProductNDC>0078-0467</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desferal</ProprietaryName>
    <NonProprietaryName>Deferoxamine Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680402</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016267</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>DEFEROXAMINE MESYLATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DESFERAL is an iron-chelating agent indicated: 1 As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1) , 2 For the treatment of transfusional iron overload in patients with chronic anemia. (1.2) .</IndicationAndUsage>
    <Description>Desferal, deferoxamine mesylate, is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg of deferoxamine mesylate USP (corresponding to 426.82 mg of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N-[5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N-hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is. Deferoxamine mesylate USP is a white to almost white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol.</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>
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    <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>
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  <NDC>
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    <ProductNDC>0591-3694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2024-06-07</LastUpdate>
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    <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>
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  <NDC>
    <NDCCode>0591-3694-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3694-30) </PackageDescription>
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    <ProductNDC>0591-3694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202645</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2024-06-07</LastUpdate>
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    <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>
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  <NDC>
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    <ProprietaryName>Paliperidone</ProprietaryName>
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    <LabelerName>Actavis Pharma, Inc.</LabelerName>
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    <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>
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    <LabelerName>Actavis Pharma, Inc.</LabelerName>
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    <LastUpdate>2024-06-07</LastUpdate>
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    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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    <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>10147-0952-3</NDCCode>
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    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
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    <LabelerName>Patriot Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <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 12–17): 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 C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone 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 (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone Extended-Release Tablets utilizes OROS ®osmotic drug-release technology. Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.</Description>
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    <SubstanceName>OXYGEN</SubstanceName>
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    <StrengthUnit>L/100L</StrengthUnit>
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    <LastUpdate>2022-10-06</LastUpdate>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
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    <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>
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    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240626</StartMarketingDatePackage>
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    <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>
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    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
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    <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>
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    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
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    <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>
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    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-279-30) </PackageDescription>
    <NDC11Code>27241-0279-30</NDC11Code>
    <ProductNDC>27241-279</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
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    <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>37808-426-54</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (37808-426-54)  / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>37808-0426-54</NDC11Code>
    <ProductNDC>37808-426</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tioconazole 1</ProprietaryName>
    <NonProprietaryName>Tioconazole</NonProprietaryName>
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    <ApplicationNumber>ANDA075915</ApplicationNumber>
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    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
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    <IndicationAndUsage>treats vaginal yeast infections.</IndicationAndUsage>
  </NDC>
  <NDC>
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    <NDC11Code>43602-0294-05</NDC11Code>
    <ProductNDC>43602-294</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
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    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>43602-294-07</NDCCode>
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    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>
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    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>43602-295-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-295-05) </PackageDescription>
    <NDC11Code>43602-0295-05</NDC11Code>
    <ProductNDC>43602-295</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>43602-295-07</NDCCode>
    <PackageDescription>7 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-295-07) </PackageDescription>
    <NDC11Code>43602-0295-07</NDC11Code>
    <ProductNDC>43602-295</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>43602-295-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-295-30) </PackageDescription>
    <NDC11Code>43602-0295-30</NDC11Code>
    <ProductNDC>43602-295</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paliperidone</ProprietaryName>
    <NonProprietaryName>Paliperidone</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216174</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALIPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Paliperidone extended-release tablets contain paliperidone, USP 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, 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 (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD &amp; C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. 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 capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices 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>