RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>63304-949-17</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX, UNIT-DOSE (63304-949-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-949-11) </PackageDescription>
    <NDC11Code>63304-0949-17</NDC11Code>
    <ProductNDC>63304-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-949-05</NDCCode>
    <PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-05) </PackageDescription>
    <NDC11Code>63304-0949-05</NDC11Code>
    <ProductNDC>63304-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-949-30</NDCCode>
    <PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-30) </PackageDescription>
    <NDC11Code>63304-0949-30</NDC11Code>
    <ProductNDC>63304-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-643-17</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11) </PackageDescription>
    <NDC11Code>63304-0643-17</NDC11Code>
    <ProductNDC>63304-643</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078474</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-644-17</NDCCode>
    <PackageDescription>1 POUCH in 1 BOX, UNIT-DOSE (63304-644-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-644-11) </PackageDescription>
    <NDC11Code>63304-0644-17</NDC11Code>
    <ProductNDC>63304-644</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078474</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-950-17</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX, UNIT-DOSE (63304-950-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-950-11) </PackageDescription>
    <NDC11Code>63304-0950-17</NDC11Code>
    <ProductNDC>63304-950</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-951-17</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX, UNIT-DOSE (63304-951-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-951-11) </PackageDescription>
    <NDC11Code>63304-0951-17</NDC11Code>
    <ProductNDC>63304-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-949-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16714-949-01) </PackageDescription>
    <NDC11Code>16714-0949-01</NDC11Code>
    <ProductNDC>16714-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202424</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
    <Description>A single-entity amphetamine product combining the neutral sulfate salts of Dextroamphetamine and amphetamine, with the Dextro isomer of amphetamine Saccharate and d, 1-amphetamine aspartate. 11.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied21.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied32.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied43.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied55 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied67.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients. In addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Colors. The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&amp;C Blue #1 Aluminum Lake. The 15 mg, 20 mg, and 30 mg tablets contain the color additive FD&amp;C Yellow #6 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-949-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-949-60)</PackageDescription>
    <NDC11Code>21695-0949-60</NDC11Code>
    <ProductNDC>21695-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Opana Er</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060622</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021610</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended for use as a prn analgesic. OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.</IndicationAndUsage>
    <Description>OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: hypromellose, iron oxide black, methylparaben, propylene glycol, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx® -N, titanium dioxide, and triacetin. The 5 mg, 10 mg and 20 mg tablets also contain macrogol, and polysorbate 80. In addition, the 5 mg tablets contain iron oxide red. The 10 mg tablets contain FD&amp;C yellow No. 6. The 20 mg tablets contain FD&amp;C blue No. 1, FD&amp;C yellow No. 6, and D&amp;C yellow No. 10. The 40 mg tablets contain FD&amp;C yellow No. 6, D&amp;C yellow No. 10, and lactose monohydrate. Chemically, oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. The tablet strengths, 5, 10, 20 and 40 mg, describe the amount of oxymorphone hydrochloride per tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-949-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (31722-949-01) </PackageDescription>
    <NDC11Code>31722-0949-01</NDC11Code>
    <ProductNDC>31722-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207419</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP                                                            2.5 mg*. (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                             5 mg*. (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            7.5 mg*. (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            10 mg*. (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-949-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (31722-949-05) </PackageDescription>
    <NDC11Code>31722-0949-05</NDC11Code>
    <ProductNDC>31722-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207419</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP                                                            2.5 mg*. (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                             5 mg*. (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            7.5 mg*. (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            10 mg*. (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-949-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (51407-949-30) </PackageDescription>
    <NDC11Code>51407-0949-30</NDC11Code>
    <ProductNDC>51407-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</ProprietaryName>
    <NonProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20140627</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203326</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>8; 2</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
    <Description>Buprenorphine and Naloxone Sublingual Tablets, USP are available in two dosage strengths intended for sublingual administration as follows: 2 mg buprenorphine with 0.5 mg naloxone free bases and 8 mg buprenorphine with 2 mg naloxone free bases. Each tablet also contains citric acid anhydrous, corn starch, FD &amp; C yellow no. 6, lactose monohydrate, lemon-lime flavor, magnesium stearate, mannitol, povidone, sodium citrate dihydrate and sucralose. Chemically, buprenorphine HCl is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O--methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure: 1 .</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-949-01</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (64380-949-01)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>64380-0949-01</NDC11Code>
    <ProductNDC>64380-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208412</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler's syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. Prednisone Tablets USP…………………………………… 10 mg, 20 mg and 50 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy  The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>64380-949-06</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (64380-949-06) </PackageDescription>
    <NDC11Code>64380-0949-06</NDC11Code>
    <ProductNDC>64380-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208412</ApplicationNumber>
    <LabelerName>Strides Pharma Science Limited</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler's syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. Prednisone Tablets USP…………………………………… 10 mg, 20 mg and 50 mg. Inactive Ingredients. The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy  The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-949-03</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-949-03) </PackageDescription>
    <NDC11Code>65162-0949-03</NDC11Code>
    <ProductNDC>65162-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207497</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2)  .</IndicationAndUsage>
    <Description>Lamotrigine, USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP, is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP, is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets USP, are supplied for oral administration as 25 mg (yellow), 50 mg (green), 100 mg (beige), 200 mg (blue), 250 mg (purple) and 300 mg (gray) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 25 mg tablets also contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6. The 50 mg tablets also contain FD&amp;C Blue No. 2 and iron oxide yellow. The 100 mg tablets also contain iron oxide red and iron oxide yellow. The 200 mg tablets also contain FD&amp;C Blue No. 2. The 250 mg tablets also contain FD&amp;C Blue No. 2 and FD&amp;C Red No. 40. The 300 mg tablets also contain black iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The core tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of the drug in the acidic environment of the stomach. The combinations of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-949-09</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-949-09) </PackageDescription>
    <NDC11Code>65162-0949-09</NDC11Code>
    <ProductNDC>65162-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207497</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2)  .</IndicationAndUsage>
    <Description>Lamotrigine, USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP, is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP, is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets USP, are supplied for oral administration as 25 mg (yellow), 50 mg (green), 100 mg (beige), 200 mg (blue), 250 mg (purple) and 300 mg (gray) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 25 mg tablets also contain D&amp;C Yellow No. 10 and FD&amp;C Yellow No. 6. The 50 mg tablets also contain FD&amp;C Blue No. 2 and iron oxide yellow. The 100 mg tablets also contain iron oxide red and iron oxide yellow. The 200 mg tablets also contain FD&amp;C Blue No. 2. The 250 mg tablets also contain FD&amp;C Blue No. 2 and FD&amp;C Red No. 40. The 300 mg tablets also contain black iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The core tablets are coated with an enteric coat and have pore forming ingredient in the coat to enable a controlled release of the drug in the acidic environment of the stomach. The combinations of the modified-release core and the enteric coat are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>66267-949-30</NDCCode>
    <PackageDescription>30 g in 1 TUBE (66267-949-30) </PackageDescription>
    <NDC11Code>66267-0949-30</NDC11Code>
    <ProductNDC>66267-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150619</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062367</ApplicationNumber>
    <LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>100000; 1</StrengthNumber>
    <StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
    <Description>Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a structural formula of C 47H 75NO 17 and a molecular weight of 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a structural formula of C 24H 31FO 6 and a molecular weight of 434.50. Nystatin and Triamcinolone Acetonide Cream, USP is a soft, smooth cream having a light yellow color. Each gram provides 100,000 Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base containing aluminum hydroxide rehydragel, barcroft aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, glyceryl monostearate, polyethylene glycol monostearate, propylene glycol, simethicone emulsion, sorbic acid, sorbitol solution, titanium dioxide, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-218-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-218-05)</PackageDescription>
    <NDC11Code>63304-0218-05</NDC11Code>
    <ProductNDC>63304-218</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-218-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-218-30)</PackageDescription>
    <NDC11Code>63304-0218-30</NDC11Code>
    <ProductNDC>63304-218</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-219-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-219-05)</PackageDescription>
    <NDC11Code>63304-0219-05</NDC11Code>
    <ProductNDC>63304-219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-219-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-219-30)</PackageDescription>
    <NDC11Code>63304-0219-30</NDC11Code>
    <ProductNDC>63304-219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-220-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-220-05)</PackageDescription>
    <NDC11Code>63304-0220-05</NDC11Code>
    <ProductNDC>63304-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-220-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-220-30)</PackageDescription>
    <NDC11Code>63304-0220-30</NDC11Code>
    <ProductNDC>63304-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-221-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-221-05)</PackageDescription>
    <NDC11Code>63304-0221-05</NDC11Code>
    <ProductNDC>63304-221</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-221-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-221-30)</PackageDescription>
    <NDC11Code>63304-0221-30</NDC11Code>
    <ProductNDC>63304-221</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-222-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-222-05)</PackageDescription>
    <NDC11Code>63304-0222-05</NDC11Code>
    <ProductNDC>63304-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-222-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-222-30)</PackageDescription>
    <NDC11Code>63304-0222-30</NDC11Code>
    <ProductNDC>63304-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-223-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-223-05)</PackageDescription>
    <NDC11Code>63304-0223-05</NDC11Code>
    <ProductNDC>63304-223</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-223-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-223-30)</PackageDescription>
    <NDC11Code>63304-0223-30</NDC11Code>
    <ProductNDC>63304-223</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>63304-224-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-224-05)</PackageDescription>
    <NDC11Code>63304-0224-05</NDC11Code>
    <ProductNDC>63304-224</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203506</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&amp;C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&amp;C yellow No. 6. The 20 mg tablets contain D&amp;C yellow No. 10, FD&amp;C blue No. 1, and FD&amp;C yellow No. 6. The 30 mg tablets contain FD&amp;C blue No. 1 and FD&amp;C yellow No. 6. The 40 mg tablets contain D&amp;C yellow No. 10 and FD&amp;C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
  </NDC>
</NDCList>