RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>53746-839-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-839-90) </PackageDescription>
    <NDC11Code>53746-0839-90</NDC11Code>
    <ProductNDC>53746-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204011</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults. (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults. (1.3).</IndicationAndUsage>
    <Description>Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L­-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52 g/mol, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxides (yellow, black and/or red), macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-839-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (53746-839-05) </PackageDescription>
    <NDC11Code>53746-0839-05</NDC11Code>
    <ProductNDC>53746-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204011</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults. (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults. (1.3).</IndicationAndUsage>
    <Description>Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L­-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52 g/mol, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxides (yellow, black and/or red), macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-839-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (53746-839-10) </PackageDescription>
    <NDC11Code>53746-0839-10</NDC11Code>
    <ProductNDC>53746-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204011</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults. (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults. (1.3).</IndicationAndUsage>
    <Description>Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L­-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52 g/mol, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxides (yellow, black and/or red), macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-839-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (21695-839-90)</PackageDescription>
    <NDC11Code>21695-0839-90</NDC11Code>
    <ProductNDC>21695-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074821</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>37.5; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the action of these agents, dosage adjustments may be necessary.</IndicationAndUsage>
    <Description>Triamterene is an antikaliuretic agent and hydrochlorothiazide is a diuretic/antihypertensive agent. At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2,4,7-triamino-6-phenylpteridine with a chemical formula of C12H11N7 and a molecular weight of 253.27. The structural formula for triamterene is. Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide with a chemical formula of C7H8ClN3O4S2 and a molecular weight of 297.75. The structural formula for hydrochlorothiazide is. Each capsule, for oral administration, contains 37.5 mg triamterene and 25 mg hydrochlorothiazide. Inactive ingredients include: citric acid, corn starch, glycine, anhydrous lactose, magnesium stearate, Polysorbate 80, povidone, and sodium starch glycolate. The capsule shells and imprinting inks contain: D &amp; C Yellow #10 Aluminum Lake, FD &amp; C Blue #1 Aluminum Lake, FD &amp; C Blue #2 Aluminum Lake, FD &amp; C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze, propylene glycol, synthetic black iron oxide, and titanium dioxide. This product complies with dissolution test #3.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-839-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (33261-839-90)</PackageDescription>
    <NDC11Code>33261-0839-90</NDC11Code>
    <ProductNDC>33261-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078938</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid.The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD and C blue # 1, FD and C red # 40, FD and C yellow # 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.*USP dissolution test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-839-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (35356-839-90) </PackageDescription>
    <NDC11Code>35356-0839-90</NDC11Code>
    <ProductNDC>35356-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydchloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydchloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111220</StartMarketingDate>
    <EndMarketingDate>20270630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091393</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20111220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose, silicon dioxide, sodium starch glycolate; and stearic acid. T.he 10 mg tablet also contains D&amp;C Red No. 27 aluminum lake. The 15 mg tablet also contains D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Blue No.2 aluminum lake. The20 mg tablet also contains FD&amp;C Blue No. 2 aluminum lake; FD&amp;C Red No. 40 aluminum lake; and FD&amp;C Yellow No.6 aluminum lake. The 30 mg tablet also contains FD&amp;C Blue No.2 aluminum lakeBlue No. 2 (15 mg and 30 mg tablets). The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-839-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (43063-839-90) </PackageDescription>
    <NDC11Code>43063-0839-90</NDC11Code>
    <ProductNDC>43063-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax ®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-839-60</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-839-60)</PackageDescription>
    <NDC11Code>43353-0839-60</NDC11Code>
    <ProductNDC>43353-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Probenecid</ProprietaryName>
    <NonProprietaryName>Probenecid</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080966</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>PROBENECID</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.</IndicationAndUsage>
    <Description>Probenecid is a uricosuric and renal tubular transport blocking agent. The chemical name for probenecid is 4-[(dipropylamino) sulfony1] benzoic acid. It has the following structural formula. Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Each tablet for oral administration contains 500 mg of probenecid and the following inactive ingredients: Microcrystalline cellulose, corn starch, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Yellow #6 Aluminum Lake, and FD&amp;C Blue #2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>49999-839-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (49999-839-90)</PackageDescription>
    <NDC11Code>49999-0839-90</NDC11Code>
    <ProductNDC>49999-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101011</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040517</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-12</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61919-839-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (61919-839-90)</PackageDescription>
    <NDC11Code>61919-0839-90</NDC11Code>
    <ProductNDC>61919-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075350</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>.</IndicationAndUsage>
    <Description>.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-839-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (63187-839-90) </PackageDescription>
    <NDC11Code>63187-0839-90</NDC11Code>
    <ProductNDC>63187-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078955</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
    <Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &amp;C yellow No.6 Aluminium Lake and Color D&amp;C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&amp;C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&amp;C Red No. 30 Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-839-09</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (65162-839-09) </PackageDescription>
    <NDC11Code>65162-0839-09</NDC11Code>
    <ProductNDC>65162-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204011</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68405-017-36</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (68405-017-36)  *  30 TABLET in 1 BOTTLE (52959-839-30)  *  90 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>68405-0017-36</NDC11Code>
    <ProductNDC>68405-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hypertensolol</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate, Arginine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20110707</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Physician Therapeutics LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69097-839-05</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69097-839-05) </PackageDescription>
    <NDC11Code>69097-0839-05</NDC11Code>
    <ProductNDC>69097-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinapril</ProprietaryName>
    <NonProprietaryName>Quinapril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078457</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. Quinapril is 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
    <Description>Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol).</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-839-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-90) </PackageDescription>
    <NDC11Code>71205-0839-90</NDC11Code>
    <ProductNDC>71205-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215848</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below. Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains FD&amp;C Blue No. 1 Aluminum Lake (2.5 mg and 5 mg tablet), FD&amp;C Blue No. 2 Aluminum Lake (2.5 mg tablet), FD&amp;C Red No. 3 Aluminum Lake (5 mg tablet), FD&amp;C Yellow No. 5 Aluminum Lake (5 mg tablet), FD&amp;C Yellow No. 6 Aluminum Lake (10 mg tablet), lactose monohydrate, hypromellos, microcrystalline cellulose, magnesium stearate, polyethylene glycol 3350, polyvinyl alcohol, purified water, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-839-60</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60) </PackageDescription>
    <NDC11Code>71610-0839-60</NDC11Code>
    <ProductNDC>71610-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078970</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>6.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES ( 14)].</IndicationAndUsage>
    <Description>Zolpidem tartrate extended-release tablets USP contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets USP are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white or almost white, crystalline powder, hygroscopic that is slightly soluble in water, sparingly soluble in methanol and practically insoluble in methylene chloride. It has a molecular weight of 764.87. Zolpidem tartrate extended-release tablets USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg zolpidem tartrate extended-release tablets USP contain the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue # 2 aluminium lake, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate and titanium dioxide. The 12.5 mg zolpidem tartrate extended-release tablets USP contain the following inactive ingredients: colloidal silicon dioxide, FD&amp;C Blue # 2 aluminium lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate and titanium dioxide. Zolpidem tartrate extended-release tablets USP meets USP Dissolution Test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-839-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-839-90) </PackageDescription>
    <NDC11Code>76420-0839-90</NDC11Code>
    <ProductNDC>76420-839</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213324</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-019-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90) </PackageDescription>
    <NDC11Code>53746-0019-90</NDC11Code>
    <ProductNDC>53746-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205619</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: : 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. , 2 generalized anxiety disorder (GAD) in adults. .</IndicationAndUsage>
    <Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-020-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (53746-020-90) </PackageDescription>
    <NDC11Code>53746-0020-90</NDC11Code>
    <ProductNDC>53746-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205619</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: : 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. , 2 generalized anxiety disorder (GAD) in adults. .</IndicationAndUsage>
    <Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-021-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (53746-021-90) </PackageDescription>
    <NDC11Code>53746-0021-90</NDC11Code>
    <ProductNDC>53746-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205619</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: : 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. , 2 generalized anxiety disorder (GAD) in adults. .</IndicationAndUsage>
    <Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-132-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-132-90) </PackageDescription>
    <NDC11Code>53746-0132-90</NDC11Code>
    <ProductNDC>53746-132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071335</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 600 mg tablets for oral administration. Inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Titanium Dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-137-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-137-90) </PackageDescription>
    <NDC11Code>53746-0137-90</NDC11Code>
    <ProductNDC>53746-137</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071935</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 800 mg tablets for oral administration. Inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Titanium Dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-178-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-90) </PackageDescription>
    <NDC11Code>53746-0178-90</NDC11Code>
    <ProductNDC>53746-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078596</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride extended-release tablets, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride extended-release tablets, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride extended-release tablets, USP is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Dissolution Method: Test 10. System Components and Performance - Metformin hydrochloride extended-release tablets, comprise a dual hydrophilic polymer matrix system. Metformin hydrochloride  is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-179-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-179-90) </PackageDescription>
    <NDC11Code>53746-0179-90</NDC11Code>
    <ProductNDC>53746-179</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078596</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride extended-release tablets, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride extended-release tablets, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride extended-release tablets, USP is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Dissolution Method: Test 10. System Components and Performance - Metformin hydrochloride extended-release tablets, comprise a dual hydrophilic polymer matrix system. Metformin hydrochloride  is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-351-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-351-90) </PackageDescription>
    <NDC11Code>53746-0351-90</NDC11Code>
    <ProductNDC>53746-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202025</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sildenafil citrate, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, round shaped film-coated tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-464-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-464-90) </PackageDescription>
    <NDC11Code>53746-0464-90</NDC11Code>
    <ProductNDC>53746-464</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078558</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-465-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-465-90) </PackageDescription>
    <NDC11Code>53746-0465-90</NDC11Code>
    <ProductNDC>53746-465</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078558</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-466-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-466-90) </PackageDescription>
    <NDC11Code>53746-0466-90</NDC11Code>
    <ProductNDC>53746-466</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078558</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-511-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-511-90) </PackageDescription>
    <NDC11Code>53746-0511-90</NDC11Code>
    <ProductNDC>53746-511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091426</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. (1.1), 2 Use as an add-on therapy 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. (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. (1.3), 4 Treatment of primary hyperaldosternism for: (1.4).</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&amp;C yellow # 10 and FD&amp;C yellow # 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>53746-514-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (53746-514-90) </PackageDescription>
    <NDC11Code>53746-0514-90</NDC11Code>
    <ProductNDC>53746-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100802</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091426</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. (1.1), 2 Use as an add-on therapy 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. (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. (1.3), 4 Treatment of primary hyperaldosternism for: (1.4).</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&amp;C yellow # 10 and FD&amp;C yellow # 6.</Description>
  </NDC>
</NDCList>