RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>31722-496-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18) </PackageDescription>
    <NDC11Code>31722-0496-18</NDC11Code>
    <ProductNDC>31722-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivaroxaban</ProprietaryName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219332</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIVAROXABAN</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
    <Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&amp;C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-496-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-496-60) </PackageDescription>
    <NDC11Code>31722-0496-60</NDC11Code>
    <ProductNDC>31722-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivaroxaban</ProprietaryName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219332</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIVAROXABAN</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
    <Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&amp;C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-462-18</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (31722-462-18)  &gt; 6 TABLET in 1 BLISTER PACK (31722-462-06)</PackageDescription>
    <NDC11Code>31722-0462-18</NDC11Code>
    <ProductNDC>31722-462</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204339</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Information related usage  of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck &amp; Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck &amp; Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. Limitations of Use.  Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.   Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-463-18</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (31722-463-18)  &gt; 6 TABLET in 1 BLISTER PACK (31722-463-06)</PackageDescription>
    <NDC11Code>31722-0463-18</NDC11Code>
    <ProductNDC>31722-463</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204339</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Information related usage  of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck &amp; Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck &amp; Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. Limitations of Use.  Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.   Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-551-18</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (31722-551-18) </PackageDescription>
    <NDC11Code>31722-0551-18</NDC11Code>
    <ProductNDC>31722-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120629</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091264</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120629</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levocetirizine dihydrochloride is a histamine H 1-receptor antagonist indicated for:  The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2).</IndicationAndUsage>
    <Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H 1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Levocetirizine dihydrochloride USP is white to almost white powder and is freely soluble in water and in methanol.  Levocetirizine dihydrochloride tablets, USP 5 mg are white film coated, scored, round, biconvex tablets for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose and opadry white YS-1-7003 which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-586-34</NDCCode>
    <PackageDescription>18 BLISTER PACK in 1 CARTON (31722-586-34)  / 7 TABLET in 1 BLISTER PACK (31722-586-33) </PackageDescription>
    <NDC11Code>31722-0586-34</NDC11Code>
    <ProductNDC>31722-586</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203825</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&amp;C Red No.27 AL Lake, FD &amp; C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-587-34</NDCCode>
    <PackageDescription>18 BLISTER PACK in 1 CARTON (31722-587-34)  / 7 TABLET in 1 BLISTER PACK (31722-587-33) </PackageDescription>
    <NDC11Code>31722-0587-34</NDC11Code>
    <ProductNDC>31722-587</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203825</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&amp;C Red No.27 AL Lake, FD &amp; C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-588-34</NDCCode>
    <PackageDescription>18 BLISTER PACK in 1 CARTON (31722-588-34)  / 7 TABLET in 1 BLISTER PACK (31722-588-33) </PackageDescription>
    <NDC11Code>31722-0588-34</NDC11Code>
    <ProductNDC>31722-588</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203825</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&amp;C Red No.27 AL Lake, FD &amp; C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-673-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-673-18) </PackageDescription>
    <NDC11Code>31722-0673-18</NDC11Code>
    <ProductNDC>31722-673</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213668</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:   to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1).   for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2).</IndicationAndUsage>
    <Description>Sacubitril and Valsartan Tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3 respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3’-methyl-2’-(pentanoyl {2”-(tetrazol-5-ylate) biphenyl-4’-ylmethyl} amino) butyrate]. Its molecular formula is C 48H 57N 6O 8.3Na. Its molecular mass is 912.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide. The film-coat inactive ingredients are hypromellose, di-acetylated monoglycerides, titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains FD&amp;C Blue No. 2. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-674-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-674-18) </PackageDescription>
    <NDC11Code>31722-0674-18</NDC11Code>
    <ProductNDC>31722-674</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213668</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:   to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1).   for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2).</IndicationAndUsage>
    <Description>Sacubitril and Valsartan Tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3 respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3’-methyl-2’-(pentanoyl {2”-(tetrazol-5-ylate) biphenyl-4’-ylmethyl} amino) butyrate]. Its molecular formula is C 48H 57N 6O 8.3Na. Its molecular mass is 912.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide. The film-coat inactive ingredients are hypromellose, di-acetylated monoglycerides, titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains FD&amp;C Blue No. 2. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-675-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-675-18) </PackageDescription>
    <NDC11Code>31722-0675-18</NDC11Code>
    <ProductNDC>31722-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213668</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:   to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. ( 1.1).   for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2).</IndicationAndUsage>
    <Description>Sacubitril and Valsartan Tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3 respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3’-methyl-2’-(pentanoyl {2”-(tetrazol-5-ylate) biphenyl-4’-ylmethyl} amino) butyrate]. Its molecular formula is C 48H 57N 6O 8.3Na. Its molecular mass is 912.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide. The film-coat inactive ingredients are hypromellose, di-acetylated monoglycerides, titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains FD&amp;C Blue No. 2. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-812-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-812-18) </PackageDescription>
    <NDC11Code>31722-0812-18</NDC11Code>
    <ProductNDC>31722-812</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204787</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide tablets are indicated for:   Treatment of partial-onset seizures in patients 1 month  of age and older ( 1.1).    Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)- N-Benzyl-2-acetamido-3-methoxy propionamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-813-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-813-18) </PackageDescription>
    <NDC11Code>31722-0813-18</NDC11Code>
    <ProductNDC>31722-813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204787</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide tablets are indicated for:   Treatment of partial-onset seizures in patients 1 month  of age and older ( 1.1).    Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)- N-Benzyl-2-acetamido-3-methoxy propionamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-814-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-814-18) </PackageDescription>
    <NDC11Code>31722-0814-18</NDC11Code>
    <ProductNDC>31722-814</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204787</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide tablets are indicated for:   Treatment of partial-onset seizures in patients 1 month  of age and older ( 1.1).    Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)- N-Benzyl-2-acetamido-3-methoxy propionamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-815-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-815-18) </PackageDescription>
    <NDC11Code>31722-0815-18</NDC11Code>
    <ProductNDC>31722-815</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204787</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide tablets are indicated for:   Treatment of partial-onset seizures in patients 1 month  of age and older ( 1.1).    Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)- N-Benzyl-2-acetamido-3-methoxy propionamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-891-18</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (31722-891-18)  / 180 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>31722-0891-18</NDC11Code>
    <ProductNDC>31722-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Oxybate</ProprietaryName>
    <NonProprietaryName>Sodium Oxybate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210523</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM OXYBATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Sodium oxybate, a CNS depressant, is the active ingredient in sodium oxybate oral solution. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is.    Sodium oxybate is a white to off-white, powder that is very soluble in aqueous solutions. Each mL of sodium oxybate oral solution contains 0.5 g of sodium oxybate (equivalent to 0.413 g/mL of oxybate) in USP Purified Water, neutralized to pH 7.5 with malic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-832-31</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31) </PackageDescription>
    <NDC11Code>31722-0832-31</NDC11Code>
    <ProductNDC>31722-832</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205166</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1)  Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2)  Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an  n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-832-32</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 CARTON (31722-832-32) </PackageDescription>
    <NDC11Code>31722-0832-32</NDC11Code>
    <ProductNDC>31722-832</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205166</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1)  Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2)  Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an  n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-832-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-832-60) </PackageDescription>
    <NDC11Code>31722-0832-60</NDC11Code>
    <ProductNDC>31722-832</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205166</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1)  Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2)  Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an  n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0603-6330-20</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20) </PackageDescription>
    <NDC11Code>00603-6330-20</NDC11Code>
    <ProductNDC>0603-6330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200790</ApplicationNumber>
    <LabelerName>Par Pharmaceutical</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir Tablets, USP are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir Tablets, USP contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir Tablets, USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone K-30, and stearic acid. The film-coat applied to the tablets contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Valganciclovir HCl is a white to off-white amorphous powder with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-496-11</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (33342-496-11) </PackageDescription>
    <NDC11Code>33342-0496-11</NDC11Code>
    <ProductNDC>33342-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
    <NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214495</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
    <StrengthNumber>50; 200; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:  : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
    <Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone film coated tablets is supplied as tablets in 6 strengths: 12.5 mg of carbidopa, USP; 50 mg of levodopa, USP and 200 mg of entacapone USP 18.75 mg of carbidopa, USP; 75 mg of levodopa, USP and 200 mg of entacapone USP 25 mg of carbidopa, USP; 100 mg of levodopa, USP and 200 mg of entacapone USP 31.25 mg of carbidopa, USP; 125 mg of levodopa, USP and 200 mg of entacapone USP 37.5 mg of carbidopa, USP; 150 mg of levodopa, USP and 200 mg of entacapone USP 50 mg of carbidopa, USP; 200 mg of levodopa, USP and 200 mg of entacapone USP. Inactive Ingredients: Colloidal silicon dioxide, Croscarmellose sodium, Crospovidone, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Povidone. The coating material Instacoat Brown HIS consists of Hypromellose, Polysorbate 80, Red Iron Oxide, Titanium Dioxide,  Yellow Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-496-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-496-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0496-12</NDC11Code>
    <ProductNDC>33342-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
    <NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214495</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
    <StrengthNumber>50; 200; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa, levodopa and entacapone tablets, is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used:  : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
    <Description>Carbidopa, levodopa and entacapone tablets is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone film coated tablets is supplied as tablets in 6 strengths: 12.5 mg of carbidopa, USP; 50 mg of levodopa, USP and 200 mg of entacapone USP 18.75 mg of carbidopa, USP; 75 mg of levodopa, USP and 200 mg of entacapone USP 25 mg of carbidopa, USP; 100 mg of levodopa, USP and 200 mg of entacapone USP 31.25 mg of carbidopa, USP; 125 mg of levodopa, USP and 200 mg of entacapone USP 37.5 mg of carbidopa, USP; 150 mg of levodopa, USP and 200 mg of entacapone USP 50 mg of carbidopa, USP; 200 mg of levodopa, USP and 200 mg of entacapone USP. Inactive Ingredients: Colloidal silicon dioxide, Croscarmellose sodium, Crospovidone, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Povidone. The coating material Instacoat Brown HIS consists of Hypromellose, Polysorbate 80, Red Iron Oxide, Titanium Dioxide,  Yellow Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55910-496-15</NDCCode>
    <PackageDescription>420 mL in 1 BOTTLE, PLASTIC (55910-496-15) </PackageDescription>
    <NDC11Code>55910-0496-15</NDC11Code>
    <ProductNDC>55910-496</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>2 In 1 Dandruff</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211007</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>OLD EAST MAIN CO</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63323-496-97</NDCCode>
    <PackageDescription>5 AMPULE in 1 BOX (63323-496-97)  / 10 mL in 1 AMPULE (63323-496-03) </PackageDescription>
    <NDC11Code>63323-0496-97</NDC11Code>
    <ProductNDC>63323-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine</ProprietaryName>
    <ProprietaryNameSuffix>Mpf</ProprietaryNameSuffix>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20110718</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14H 22N 2O  HCl) has the following structural formula:. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C 9H 13NO 3) has the following structural formula:. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-753-18</NDCCode>
    <PackageDescription>180 TABLET in 1 BOTTLE (65862-753-18) </PackageDescription>
    <NDC11Code>65862-0753-18</NDC11Code>
    <ProductNDC>65862-753</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir Hydrochloride</ProprietaryName>
    <NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204750</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a  deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets USP contain valganciclovir hydrochloride, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.Valganciclovir hydrochloride USP is a white to off-white powder with a molecular formula of C14H22N6O5·HCl and a molecular weight of 390.83. The chemical name for valganciclovir hydrochloride is L-Valine, 2-­[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.6.The chemical structure of valganciclovir hydrochloride is.   All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>68084-965-19</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (68084-965-19)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18) </PackageDescription>
    <NDC11Code>68084-0965-19</NDC11Code>
    <ProductNDC>68084-965</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203511</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients(1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets USP contains valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film-coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide. Valganciclovir hydrochloride USP is a white to almost white powder with a molecular formula of C 14H 22N 6O 5HCl and a molecular weight of 390.71. The chemical name for valganciclovir hydrochloride USP is L-Valine, 2[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride USP is a polar hydrophilic compound with a saturation solubility of 6029 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.00701 at pH 5.1. The pKa for valganciclovir hydrochloride USP is 7.2. The chemical structure of valganciclovir hydrochloride USP is. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>68645-496-59</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68645-496-59) </PackageDescription>
    <NDC11Code>68645-0496-59</NDC11Code>
    <ProductNDC>68645-496</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol</ProprietaryName>
    <NonProprietaryName>Carvedilol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077614</ApplicationNumber>
    <LabelerName>Legacy Pharmaceutical Packaging, LLC</LabelerName>
    <SubstanceName>CARVEDILOL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.2) , 3 Hypertension( 1.3) .</IndicationAndUsage>
    <Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide. The product meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>72988-0010-2</NDCCode>
    <PackageDescription>30 POUCH in 1 POUCH (72988-0010-2)  / 3.5 g in 1 POUCH (72988-0010-1) </PackageDescription>
    <NDC11Code>72988-0010-02</NDC11Code>
    <ProductNDC>72988-0010</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Laxatives Rubilax</ProprietaryName>
    <NonProprietaryName>Psyllium Huskpowder</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190422</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Lydia Co., Ltd.</LabelerName>
    <SubstanceName>PSYLLIUM HUSK; SENNA PODS</SubstanceName>
    <StrengthNumber>2168; 496</StrengthNumber>
    <StrengthUnit>mg/3.5g; mg/3.5g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83021-553-60</NDCCode>
    <PackageDescription>60 mL in 1 JAR (83021-553-60) </PackageDescription>
    <NDC11Code>83021-0553-60</NDC11Code>
    <ProductNDC>83021-553</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anubis Barcelona</ProprietaryName>
    <NonProprietaryName>Dmae, Zirhafirm</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230113</StartMarketingDate>
    <EndMarketingDate>20280306</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>ANUBIS COSMETICS SL</LabelerName>
    <SubstanceName>ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER</SubstanceName>
    <StrengthNumber>5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1</StrengthNumber>
    <StrengthUnit>g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; mL/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230113</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280306</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-046-31</NDCCode>
    <PackageDescription>1 POWDER, FOR SOLUTION in 1 PACKET (31722-046-31) </PackageDescription>
    <NDC11Code>31722-0046-31</NDC11Code>
    <ProductNDC>31722-046</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Potassium</ProprietaryName>
    <NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220304</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215375</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use:  Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine.  The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
    <Description>Diclofenac potassium for oral solution is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is potassium [o-(2,6-dichloroanilino) phenyl] acetate. The molecular weight is 334.24 g/mole. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structure.     The inactive ingredients in diclofenac potassium for oral solution include: flavoring agent (peppermint), glyceryl behenate, mannitol, sucralose and tribasic sodium phosphate anhydrous.</Description>
  </NDC>
</NDCList>