RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
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    <NDCCode>0407-0690-43</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (0407-0690-43)  &gt; 20 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00407-0690-43</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-1413-43</NDCCode>
    <PackageDescription>10 BOTTLE in 1 BOX (0407-1413-43)  &gt; 100 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00407-1413-43</NDC11Code>
    <ProductNDC>0407-1413</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omnipaque</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
    <StartMarketingDate>20060921</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018956</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-1414-43</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-1414-43)  &gt; 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-1414-43</NDC11Code>
    <ProductNDC>0407-1414</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omnipaque</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
    <StartMarketingDate>20060721</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018956</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-05</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-05)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-05</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250727</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-10</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-10)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-10</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-12</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 BOX (0407-0690-12)  &gt; 10 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00407-0690-12</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-15</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-15)  / 15 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-15</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-17</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 BOX (0407-0690-17)  &gt; 15 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00407-0690-17</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-20</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-20)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-20</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-22</NDCCode>
    <PackageDescription>10 SYRINGE, PLASTIC in 1 BOX (0407-0690-22)  &gt; 20 mL in 1 SYRINGE, PLASTIC</PackageDescription>
    <NDC11Code>00407-0690-22</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020419</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-30</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-30)  / 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-30</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240505</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-40</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-40)  / 15 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-40</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240410</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
    <Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-42</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (0407-0690-42)  &gt; 15 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00407-0690-42</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-50</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (0407-0690-50)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00407-0690-50</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020123</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0407-0690-70</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-0690-70)  &gt; 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00407-0690-70</NDC11Code>
    <ProductNDC>0407-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omniscan</ProprietaryName>
    <NonProprietaryName>Gadodiamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20071002</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022066</ApplicationNumber>
    <LabelerName>GE Healthcare Inc.</LabelerName>
    <SubstanceName>GADODIAMIDE</SubstanceName>
    <StrengthNumber>287</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43353-690-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43353-690-30)</PackageDescription>
    <NDC11Code>43353-0690-30</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-690-53</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43353-690-53)</PackageDescription>
    <NDC11Code>43353-0690-53</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-690-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-690-60)</PackageDescription>
    <NDC11Code>43353-0690-60</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-690-70</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (43353-690-70)</PackageDescription>
    <NDC11Code>43353-0690-70</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-690-80</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (43353-690-80)</PackageDescription>
    <NDC11Code>43353-0690-80</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-690-84</NDCCode>
    <PackageDescription>1100 TABLET in 1 BOTTLE, PLASTIC (43353-690-84)</PackageDescription>
    <NDC11Code>43353-0690-84</NDC11Code>
    <ProductNDC>43353-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090027</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, FD&amp;C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-690-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (49483-690-03) </PackageDescription>
    <NDC11Code>49483-0690-03</NDC11Code>
    <ProductNDC>49483-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210714</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079012</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir  is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1)  Cold Sores (Herpes Labialis)   Genital Herpes          Treatment in immunocompetent patients (initial or recurrent episode)          Suppression in immunocompetent or HIV-1-infected patients          Reduction of transmission   Herpes Zoster  Pediatric Patients (1.2)  Cold Sores (Herpes Labialis)   Chickenpox  Limitations of Use (1.3) The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients pregelatinized starch, hypromellose, magnesium stearate, FD&amp;C blue #2 indigo carmine aluminum lake, titanium dioxide, polyethylene glycol, carnauba wax and polysorbate 80. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6­ oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a’s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-690-04</NDCCode>
    <PackageDescription>10 TABLET in 1 BLISTER PACK (49483-690-04) </PackageDescription>
    <NDC11Code>49483-0690-04</NDC11Code>
    <ProductNDC>49483-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210714</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079012</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir  is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1)  Cold Sores (Herpes Labialis)   Genital Herpes          Treatment in immunocompetent patients (initial or recurrent episode)          Suppression in immunocompetent or HIV-1-infected patients          Reduction of transmission   Herpes Zoster  Pediatric Patients (1.2)  Cold Sores (Herpes Labialis)   Chickenpox  Limitations of Use (1.3) The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients pregelatinized starch, hypromellose, magnesium stearate, FD&amp;C blue #2 indigo carmine aluminum lake, titanium dioxide, polyethylene glycol, carnauba wax and polysorbate 80. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6­ oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a’s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-690-41</NDCCode>
    <PackageDescription>42 TABLET in 1 BOTTLE (49483-690-41) </PackageDescription>
    <NDC11Code>49483-0690-41</NDC11Code>
    <ProductNDC>49483-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210714</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079012</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir  is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1)  Cold Sores (Herpes Labialis)   Genital Herpes          Treatment in immunocompetent patients (initial or recurrent episode)          Suppression in immunocompetent or HIV-1-infected patients          Reduction of transmission   Herpes Zoster  Pediatric Patients (1.2)  Cold Sores (Herpes Labialis)   Chickenpox  Limitations of Use (1.3) The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients pregelatinized starch, hypromellose, magnesium stearate, FD&amp;C blue #2 indigo carmine aluminum lake, titanium dioxide, polyethylene glycol, carnauba wax and polysorbate 80. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6­ oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a’s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-690-50</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (49483-690-50) </PackageDescription>
    <NDC11Code>49483-0690-50</NDC11Code>
    <ProductNDC>49483-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210714</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079012</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valacyclovir  is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (1.1)  Cold Sores (Herpes Labialis)   Genital Herpes          Treatment in immunocompetent patients (initial or recurrent episode)          Suppression in immunocompetent or HIV-1-infected patients          Reduction of transmission   Herpes Zoster  Pediatric Patients (1.2)  Cold Sores (Herpes Labialis)   Chickenpox  Limitations of Use (1.3) The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.</IndicationAndUsage>
    <Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients pregelatinized starch, hypromellose, magnesium stearate, FD&amp;C blue #2 indigo carmine aluminum lake, titanium dioxide, polyethylene glycol, carnauba wax and polysorbate 80. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6­ oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a’s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>51862-690-10</NDCCode>
    <PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (51862-690-10)  / 10 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>51862-0690-10</NDC11Code>
    <ProductNDC>51862-690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tavaborole</ProprietaryName>
    <NonProprietaryName>Tavaborole</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211297</ApplicationNumber>
    <LabelerName>Mayne Pharma Commercial LLC</LabelerName>
    <SubstanceName>TAVABOROLE</SubstanceName>
    <StrengthNumber>43.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrumor Trichophyton mentagrophytes.</IndicationAndUsage>
    <Description>Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7H 6BFO 2, the molecular weight is 151.93 and the structural formula is:. Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol USP (87.43% v/v), propylene glycol USP, and edetate calcium disodium USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42858-407-45</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-407-45) </PackageDescription>
    <NDC11Code>42858-0407-45</NDC11Code>
    <ProductNDC>42858-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aptensio Xr</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150417</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205831</ApplicationNumber>
    <LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>APTENSIO XR contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. APTENSIO XR capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. APTENSIO XR is available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14H19NO2∙HCl. Its structural formula is. Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Blue No. 1. 15 mg: D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40. 20 mg: D&amp;C Red No. 33, D&amp;C Yellow No. 10. 30 mg: FD&amp;C Blue No. 1, FD&amp;C Red No. 3. 40 mg: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40. 50 mg: D&amp;C Yellow No. 10, FD&amp;C Green No. 3. 60 mg: Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-407-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (65862-407-01) </PackageDescription>
    <NDC11Code>65862-0407-01</NDC11Code>
    <ProductNDC>65862-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090555</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white or almost white crystalline powder with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-407-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (65862-407-10)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>65862-0407-10</NDC11Code>
    <ProductNDC>65862-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090555</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white or almost white crystalline powder with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-407-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (65862-407-30) </PackageDescription>
    <NDC11Code>65862-0407-30</NDC11Code>
    <ProductNDC>65862-407</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090555</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white or almost white crystalline powder with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate.</Description>
  </NDC>
</NDCList>