RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>62778-349-40</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (62778-349-40)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>62778-0349-40</NDC11Code>
    <ProductNDC>62778-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Midazolam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216159</ApplicationNumber>
    <LabelerName>Hikma Farmaceutica</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62778-348-40</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (62778-348-40)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>62778-0348-40</NDC11Code>
    <ProductNDC>62778-348</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Midazolam In Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216159</ApplicationNumber>
    <LabelerName>Hikma Farmaceutica</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51346-349-01</NDCCode>
    <PackageDescription>40 mL in 1 CARTON (51346-349-01)</PackageDescription>
    <NDC11Code>51346-0349-01</NDC11Code>
    <ProductNDC>51346-349</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Snail Bb 02</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>3.16; 1.2; .76</StrengthNumber>
    <StrengthUnit>mg/40mL; mg/40mL; mg/40mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62778-292-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (62778-292-02)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (62778-292-01) </PackageDescription>
    <NDC11Code>62778-0292-02</NDC11Code>
    <ProductNDC>62778-292</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170922</StartMarketingDate>
    <MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
    <ApplicationNumber>NDA209463</ApplicationNumber>
    <LabelerName>Hikma Farmaceutica</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0049-3160-44</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0049-3160-44)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00049-3160-44</NDC11Code>
    <ProductNDC>0049-3160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vfend</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030328</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021630</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-3170-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-3170-30) </PackageDescription>
    <NDC11Code>00049-3170-30</NDC11Code>
    <ProductNDC>0049-3170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vfend</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030328</StartMarketingDate>
    <EndMarketingDate>20260630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021266</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20030328</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-3180-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-3180-30) </PackageDescription>
    <NDC11Code>00049-3180-30</NDC11Code>
    <ProductNDC>0049-3180</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vfend</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030328</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021266</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20030328</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-3190-28</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0049-3190-28)  / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00049-3190-28</NDC11Code>
    <ProductNDC>0049-3190</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vfend</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20030328</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021267</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)]. VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>14335-220-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (14335-220-01)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>14335-0220-01</NDC11Code>
    <ProductNDC>14335-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240402</StartMarketingDate>
    <EndMarketingDate>20250411</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216805</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240402</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250411</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole for oral suspension is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to light-colored powder. Voriconazole for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole, USP. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-349-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-349-10) </PackageDescription>
    <NDC11Code>16729-0349-10</NDC11Code>
    <ProductNDC>16729-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208049</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hydroxypropyl methyl cellulose, magnesium stearate. Additionally, the 20 mg, 40 mg, 60 mg &amp; 120 mg tablet contains hydroxylpropyl methyl cellulose 2910, talc, polyethylene glycol 6000 &amp; titanium dioxide and 80 mg tablet contains hydroxylpropyl methyl cellulose 2910, titanium dioxide, talc, polyethylene glycol 6000, iron oxide yellow and FD&amp;C Blue #2/indigo carmine aluminium lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-266-31</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (31722-266-31)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>31722-0266-31</NDC11Code>
    <ProductNDC>31722-266</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211598</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole for oral suspension is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:  Invasive aspergillosis ( 1.1)   Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2)  Esophageal candidiasis ( 1.3)   Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4).</IndicationAndUsage>
    <Description>Voriconazole an azole antifungal agent is available as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as 4-Pyrimidineethanol, α-(2,4-difluorophenyl)-5-fluoro-β-methyl- α-(1 H-1,2,4-triazol-1-ylmethyl)-, (α R, βS)- (αR, βS)-α-(2, 4-Difluorophenyl)-5-fluoro-β-methyl-α-(1 H- 1, 2, 4-triazol-1-ylmethyl)-4-pyrimidineethanol.  The molecular formula of voriconazole is C 16H 14F 3N 5O and its relative molecular mass is 349.31.  Voriconazole USP, drug substance is a white to almost white powder. Voriconazole for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, orange flavor, sodium benzoate, silicon dioxide, sucrose, titanium dioxide, tri sodium citrate dihydrate and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-349-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (31722-349-01)</PackageDescription>
    <NDC11Code>31722-0349-01</NDC11Code>
    <ProductNDC>31722-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203455</ApplicationNumber>
    <LabelerName>Camber, Pharmaceuticals Inc</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris.</IndicationAndUsage>
    <Description>Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4       M.W. 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, D&amp;C yellow No. 10, croscarmellose sodium, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-349-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (31722-349-10)</PackageDescription>
    <NDC11Code>31722-0349-10</NDC11Code>
    <ProductNDC>31722-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203455</ApplicationNumber>
    <LabelerName>Camber, Pharmaceuticals Inc</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris.</IndicationAndUsage>
    <Description>Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4       M.W. 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, D&amp;C yellow No. 10, croscarmellose sodium, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-349-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (31722-349-30)</PackageDescription>
    <NDC11Code>31722-0349-30</NDC11Code>
    <ProductNDC>31722-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203455</ApplicationNumber>
    <LabelerName>Camber, Pharmaceuticals Inc</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris.</IndicationAndUsage>
    <Description>Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5, 6, 7, 8-tetrahydro-cis-6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4       M.W. 309.40. Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, D&amp;C yellow No. 10, croscarmellose sodium, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-038-60</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (40032-038-60)  / 75 mL in 1 BOTTLE (40032-038-00) </PackageDescription>
    <NDC11Code>40032-0038-60</NDC11Code>
    <ProductNDC>40032-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206799</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as a lyophilized powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole for oral suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 49 g powder for oral suspension are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include colloidal silicon dioxide, titanium dioxide, xanthan gum, sodium citrate dihydrate, sodium benzoate, anhydrous citric acid, natural and artificial orange flavor, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-038-60</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (43386-038-60)  / 75 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43386-0038-60</NDC11Code>
    <ProductNDC>43386-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206799</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as a powder for oral suspension. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole for oral suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 49 g powder for oral suspension are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include colloidal silicon dioxide, titanium dioxide, xanthan gum, sodium citrate dihydrate, sodium benzoate, anhydrous citric acid, natural and artificial orange flavor, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-349-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (43598-349-01) </PackageDescription>
    <NDC11Code>43598-0349-01</NDC11Code>
    <ProductNDC>43598-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Progesterone</ProprietaryName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208801</ApplicationNumber>
    <LabelerName>Dr. Reddy�s Laboratories, Inc.</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
    <Description>Progesterone Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white to creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, in acetone, and in dioxane and sparingly soluble in vegetable oils, melting between 126° and 131°C. The structural formula is. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone. The inactive ingredients for progesterone capsules 100 mg include: D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin, glycerin, lecithin, peanut oil, and titanium dioxide. The inactive ingredients for progesterone capsules 200 mg include: D&amp;C Yellow No. 10, gelatin, glycerin, lecithin, peanut oil, and titanium dioxide. The imprinting Opacode® S-1-277002 Black contains, ammonium hydroxide, black iron oxide, propylene glycol and shellac (100 mg and 200 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-349-31</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31) </PackageDescription>
    <NDC11Code>46708-0349-31</NDC11Code>
    <ProductNDC>46708-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetazolamide</ProprietaryName>
    <NonProprietaryName>Acetazolamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210423</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ACETAZOLAMIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma,  and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to  lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of  symptoms associated with acute mountain sickness despite gradual  ascent.</IndicationAndUsage>
    <Description>Acetazolamide extended-release capsules are an inhibitor of the enzyme carbonic anhydrase. Acetazolamide is a white to faintly yellowish white crystalline, odorless powder, sparingly soluble in practically boiling water, very slightly soluble in water and slightly soluble in alcohol.  The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide and has the following chemical structure: MW 222.25                          C4H6N403S2 Acetazolamide are extended-release capsules, for oral administration, each containing 500 mg of acetazolamide and the following inactive ingredients: Microcrystalline cellulose, sodium lauryl sulfate and talc. The ingredients in the capsule shell are D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The ingredients in the imprinting ink are shellac, propylene glycol, potassium hydroxide and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-349-91</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91) </PackageDescription>
    <NDC11Code>46708-0349-91</NDC11Code>
    <ProductNDC>46708-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetazolamide</ProprietaryName>
    <NonProprietaryName>Acetazolamide</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210423</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ACETAZOLAMIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-03-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma,  and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to  lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of  symptoms associated with acute mountain sickness despite gradual  ascent.</IndicationAndUsage>
    <Description>Acetazolamide extended-release capsules are an inhibitor of the enzyme carbonic anhydrase. Acetazolamide is a white to faintly yellowish white crystalline, odorless powder, sparingly soluble in practically boiling water, very slightly soluble in water and slightly soluble in alcohol.  The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide and has the following chemical structure: MW 222.25                          C4H6N403S2 Acetazolamide are extended-release capsules, for oral administration, each containing 500 mg of acetazolamide and the following inactive ingredients: Microcrystalline cellulose, sodium lauryl sulfate and talc. The ingredients in the capsule shell are D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Red No. 40, gelatin and titanium dioxide. The ingredients in the imprinting ink are shellac, propylene glycol, potassium hydroxide and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>49999-349-30</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49999-349-30)</PackageDescription>
    <NDC11Code>49999-0349-30</NDC11Code>
    <ProductNDC>49999-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075584</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: FD&amp;C Blue No. 2 aluminum lake, FD&amp;C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>49999-349-60</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (49999-349-60)</PackageDescription>
    <NDC11Code>49999-0349-60</NDC11Code>
    <ProductNDC>49999-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075584</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: FD&amp;C Blue No. 2 aluminum lake, FD&amp;C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>49999-349-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (49999-349-90)</PackageDescription>
    <NDC11Code>49999-0349-90</NDC11Code>
    <ProductNDC>49999-349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20000207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075584</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: FD&amp;C Blue No. 2 aluminum lake, FD&amp;C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4204-3</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (51672-4204-3)  / 20 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51672-4204-03</NDC11Code>
    <ProductNDC>51672-4204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4204-6</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4204-6) </PackageDescription>
    <NDC11Code>51672-4204-06</NDC11Code>
    <ProductNDC>51672-4204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4205-2</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (51672-4205-2)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51672-4205-02</NDC11Code>
    <ProductNDC>51672-4205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4205-6</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4205-6) </PackageDescription>
    <NDC11Code>51672-4205-06</NDC11Code>
    <ProductNDC>51672-4205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4206-2</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (51672-4206-2)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51672-4206-02</NDC11Code>
    <ProductNDC>51672-4206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4206-6</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4206-6) </PackageDescription>
    <NDC11Code>51672-4206-06</NDC11Code>
    <ProductNDC>51672-4206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4207-2</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (51672-4207-2)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51672-4207-02</NDC11Code>
    <ProductNDC>51672-4207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>51672-4207-6</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4207-6) </PackageDescription>
    <NDC11Code>51672-4207-06</NDC11Code>
    <ProductNDC>51672-4207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Perampanel</ProprietaryName>
    <NonProprietaryName>Perampanel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209538</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>PERAMPANEL</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2) .</IndicationAndUsage>
    <Description>Perampanel tablets contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1´,6´-dihydro-6´-oxo-1´-phenyl[2,3´-bipyridin]-5´-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23H 15N 3O ∙ ¾H 2O, and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure of perampanel is:. Perampanel tablets are round, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, and titanium dioxide. The 2 mg, 4 mg, 6 mg and 8 mg also contain ferric oxide red. The 2 mg and the 10 mg also contain ferric oxide yellow. The 8 mg, 10 mg and 12 mg also contain FD&amp;C Blue No. 2 and the 8 mg contains FD&amp;C Red No. 40.</Description>
  </NDC>
</NDCList>