RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>42385-991-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-991-90) </PackageDescription>
    <NDC11Code>42385-0991-90</NDC11Code>
    <ProductNDC>42385-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218897</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</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>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for:  Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)  Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2)  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 tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-.   Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets 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, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-991-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42385-991-05) </PackageDescription>
    <NDC11Code>42385-0991-05</NDC11Code>
    <ProductNDC>42385-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218897</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</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>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for:  Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)  Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2)  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 tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-.   Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets 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, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-991-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42385-991-30) </PackageDescription>
    <NDC11Code>42385-0991-30</NDC11Code>
    <ProductNDC>42385-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218897</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</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>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for:  Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)  Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2)  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 tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-.   Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets 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, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-991-68</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (42385-991-68)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-991-10) </PackageDescription>
    <NDC11Code>42385-0991-68</NDC11Code>
    <ProductNDC>42385-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218897</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</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>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for:  Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)  Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2)  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 tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-.   Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets 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, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>24236-991-19</NDCCode>
    <PackageDescription>90 TABLET in 1 CANISTER (24236-991-19)</PackageDescription>
    <NDC11Code>24236-0991-19</NDC11Code>
    <ProductNDC>24236-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Abilify</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130409</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021436</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-991-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-991-90)</PackageDescription>
    <NDC11Code>35356-0991-90</NDC11Code>
    <ProductNDC>35356-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078503</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>43353-991-60</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-991-60) </PackageDescription>
    <NDC11Code>43353-0991-60</NDC11Code>
    <ProductNDC>43353-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Probenecid</ProprietaryName>
    <NonProprietaryName>Probenecid</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084211</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>PROBENECID</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55700-991-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (55700-991-90) </PackageDescription>
    <NDC11Code>55700-0991-90</NDC11Code>
    <ProductNDC>55700-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221227</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040400</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221227</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains. In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. Meets USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-991-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-991-90) </PackageDescription>
    <NDC11Code>60760-0991-90</NDC11Code>
    <ProductNDC>60760-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209603</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
    <Description>Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula:. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-991-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-991-90) </PackageDescription>
    <NDC11Code>61919-0991-90</NDC11Code>
    <ProductNDC>61919-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eszopiclone</ProprietaryName>
    <NonProprietaryName>Eszopiclone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091166</ApplicationNumber>
    <LabelerName>DirectRX</LabelerName>
    <SubstanceName>ESZOPICLONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
    <Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. Eszopiclone is a white to light-yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&amp;C Blue #2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64175-991-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (64175-991-90) </PackageDescription>
    <NDC11Code>64175-0991-90</NDC11Code>
    <ProductNDC>64175-991</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Relax Am-pm</ProprietaryName>
    <NonProprietaryName>Valerian Root, Passiflora, Magnesium Carbonate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111116</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Foster Regal Laboratories</LabelerName>
    <SubstanceName>VALERIAN; PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE</SubstanceName>
    <StrengthNumber>6; 3; 1</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS: For temporary relief of muscle spasms, tension and stress.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71205-991-90</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90) </PackageDescription>
    <NDC11Code>71205-0991-90</NDC11Code>
    <ProductNDC>71205-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19981113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075185</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>75</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>2022-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac is indicated: : 1 For relief of the signs and symptoms of osteoarthritis , 2 For relief of the signs and symptoms of rheumatoid arthritis , 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis .</IndicationAndUsage>
    <Description>Diclofenac sodium delayed-release tablets is a benzene-acetic acid derivative. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-991-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71610-991-60) </PackageDescription>
    <NDC11Code>71610-0991-60</NDC11Code>
    <ProductNDC>71610-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209966</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>MODAFINIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use. In OSA, modafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil for excessive sleepiness.</IndicationAndUsage>
    <Description>Modafinil is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15H 15NO 2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to almost white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Product complies with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-991-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90) </PackageDescription>
    <NDC11Code>82804-0991-90</NDC11Code>
    <ProductNDC>82804-991</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205237</ApplicationNumber>
    <LabelerName>Proficient Rx LP</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>2024-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1).</IndicationAndUsage>
    <Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile, soluble in dichloromethane and methanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-903-09</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-903-09) </PackageDescription>
    <NDC11Code>42385-0903-09</NDC11Code>
    <ProductNDC>42385-903</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>850</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42385-904-09</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-904-09) </PackageDescription>
    <NDC11Code>42385-0904-09</NDC11Code>
    <ProductNDC>42385-904</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42385-913-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-913-90) </PackageDescription>
    <NDC11Code>42385-0913-90</NDC11Code>
    <ProductNDC>42385-913</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190726</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212114</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190726</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42385-915-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90) </PackageDescription>
    <NDC11Code>42385-0915-90</NDC11Code>
    <ProductNDC>42385-915</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213541</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>600; 200; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
    <Description>Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz, USP 600 mg; emtricitabine, USP 200 mg and tenofovir disoproxil fumarate 300 mg equivalent to 245 mg of tenofovir disoproxil as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablets are film coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz, USP is a white to off white powder with a molecular mass of 315.67. It is practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula:Emtricitabine, USP is a white to almost white crystalline powder. It is freely soluble in water. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P●C4H4O4 and a molecular weight of 635.52. It has the following structural formula:TDF is a white to off white powder. It is slightly soluble in water at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-924-99</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (42385-924-99)  / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>42385-0924-99</NDC11Code>
    <ProductNDC>42385-924</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212722</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&amp;C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-925-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90) </PackageDescription>
    <NDC11Code>42385-0925-90</NDC11Code>
    <ProductNDC>42385-925</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212722</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>534</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&amp;C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-926-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-926-90) </PackageDescription>
    <NDC11Code>42385-0926-90</NDC11Code>
    <ProductNDC>42385-926</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212722</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>801</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&amp;C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-928-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) </PackageDescription>
    <NDC11Code>42385-0928-90</NDC11Code>
    <ProductNDC>42385-928</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212786</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>600; 300; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
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    <LastUpdate>2023-11-17</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
    <Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (&lt; 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-929-90</NDCCode>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213038</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>400; 300; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
    <Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (&lt; 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-929-91</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-929-91) </PackageDescription>
    <NDC11Code>42385-0929-91</NDC11Code>
    <ProductNDC>42385-929</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213038</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>400; 300; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
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    <LastUpdate>2024-05-24</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
    <Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (&lt; 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-935-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90) </PackageDescription>
    <NDC11Code>42385-0935-90</NDC11Code>
    <ProductNDC>42385-935</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210606</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>54</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake, FD &amp; C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-936-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-936-90) </PackageDescription>
    <NDC11Code>42385-0936-90</NDC11Code>
    <ProductNDC>42385-936</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210606</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake, FD &amp; C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-940-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90) </PackageDescription>
    <NDC11Code>42385-0940-90</NDC11Code>
    <ProductNDC>42385-940</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-941-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-941-90) </PackageDescription>
    <NDC11Code>42385-0941-90</NDC11Code>
    <ProductNDC>42385-941</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-942-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-942-90) </PackageDescription>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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    <LastUpdate>2025-08-22</LastUpdate>
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    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-943-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-943-90) </PackageDescription>
    <NDC11Code>42385-0943-90</NDC11Code>
    <ProductNDC>42385-943</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
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