RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>42291-161-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-161-90) </PackageDescription>
    <NDC11Code>42291-0161-90</NDC11Code>
    <ProductNDC>42291-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076820</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100729</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42291-161-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42291-161-01) </PackageDescription>
    <NDC11Code>42291-0161-01</NDC11Code>
    <ProductNDC>42291-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076820</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42291-161-50</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42291-161-50) </PackageDescription>
    <NDC11Code>42291-0161-50</NDC11Code>
    <ProductNDC>42291-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076820</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>24689-161-02</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (24689-161-02) </PackageDescription>
    <NDC11Code>24689-0161-02</NDC11Code>
    <ProductNDC>24689-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216568</ApplicationNumber>
    <LabelerName>Apnar Pharma LP</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in Nebivolol Tablets is [2S*[R*[R*[R*]]]] and [2R*[S*[S*[S*]]]]-(±) α, α'-[iminobis(metylene)] bis [6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.9 g/mol. Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in Dimethyl formamide and slightly soluble in Methanol. Nebivolol Tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, Nebivolol Tablets contain the following inactive ingredients: lactose monohydrate NF, pregelatinized starch USNF, croscarmellose sodium USNF, FD&amp;C Blue #2 aluminium lake, D&amp;C Red #27, FD&amp;C Yellow #6, hydroxypropyl methyl cellulose USP, polysorbate 80 USP-NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, magnesium stearate USP-NF, and sodium lauryl sulphate USNF.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-161-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33261-161-90)</PackageDescription>
    <NDC11Code>33261-0161-90</NDC11Code>
    <ProductNDC>33261-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204279</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Molecular Formula: C21H27ClN2O2 · 2HCl Molecular Weight:  447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-161-10</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10) </PackageDescription>
    <NDC11Code>33342-0161-10</NDC11Code>
    <ProductNDC>33342-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204815</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of:  Major depressive disorder in adults  Generalized anxiety disorder in adults and pediatric patients 7 years of age and older  Diabetic peripheral neuropathic pain in adults  Fibromyalgia in adults  Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.  Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&amp;C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, polyethylene glycol, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate.The 20 and 60 mg capsules also contain iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-005-90</NDCCode>
    <PackageDescription>3 CARTON in 1 CELLO PACK (37000-005-90)  / 1 TUBE in 1 CARTON / 161 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0005-90</NDC11Code>
    <ProductNDC>37000-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Cavity Protection Regular</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>19840802</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps protect teeth and roots against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42043-161-90</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42043-161-90)  &gt; 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>42043-0161-90</NDC11Code>
    <ProductNDC>42043-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078963</ApplicationNumber>
    <LabelerName>OrchidPharma Inc</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>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130801</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 UseIn OSA, modafinil tablets are 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 tablets for excessive sleepiness.</IndicationAndUsage>
    <Description>Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-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: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>50563-161-01</NDCCode>
    <PackageDescription>90 mL in 1 BOTTLE (50563-161-01)</PackageDescription>
    <NDC11Code>50563-0161-01</NDC11Code>
    <ProductNDC>50563-161</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Just 4 Girl Waterless Anti Bacterial Hand Sanitizer Berry Blast</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130709</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>63</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. To decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57237-161-90</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90) </PackageDescription>
    <NDC11Code>57237-0161-90</NDC11Code>
    <ProductNDC>57237-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203270</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
    <Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-­3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-161-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (61919-161-90) </PackageDescription>
    <NDC11Code>61919-0161-90</NDC11Code>
    <ProductNDC>61919-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075994</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Hypertension. Lisinopril tablets are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril tablets may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril tablets are indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril tablets are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
    <Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5  2H2O and its structural formula is. [Chemical Structure]. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, for oral administration, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets. Inactive Ingredients. 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch. 5 mg, 10 mg and 30 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, red iron oxide. 20 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, red iron oxide, yellow iron oxide. 40 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, yellow iron oxide.</Description>
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  <NDC>
    <NDCCode>65862-161-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65862-161-90) </PackageDescription>
    <NDC11Code>65862-0161-90</NDC11Code>
    <ProductNDC>65862-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinapril Hydrochloride/hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Quinapril Hydrochloride/hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070824</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078450</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>10; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension Quinapril and hydrochlorothiazide tablets are 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 and hydrochlorothiazide tablets. 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. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). In using quinapril and hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme 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: Neutropenia/Agranulocytosis). 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 and hydrochlorothiazide tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. Quinapril hydrochloride 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 molecular 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. Hydrochlorothiazide is chemically described as: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white to off-white, crystalline powder which is slightly soluble in water but freely soluble in sodium hydroxide solution. Quinapril and hydrochlorothiazide tablets, USP are available for oral use as fixed combination tablets in three strengths of quinapril with hydrochlorothiazide: 10 mg (equivalent to 10.832 mg quinapril hydrochloride USP) with 12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg (equivalent to 21.664 mg quinapril hydrochloride USP) with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20 mg (equivalent to 21.664 mg quinapril hydrochloride USP) with 25 mg (quinapril and hydrochlorothiazide 20/25). The strength of the quinapril hydrochloride component is in terms of quinapril. Inactive ingredients: lactose monohydrate, magnesium carbonate, crospovidone, povidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol 400, titanium dioxide, iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-161-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (67544-161-60) </PackageDescription>
    <NDC11Code>67544-0161-60</NDC11Code>
    <ProductNDC>67544-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atenolol</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19920501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074052</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atenolol tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol. 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 1 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2’-hydroxy-3’-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25, 50 or 100 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-161-16</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-161-16) </PackageDescription>
    <NDC11Code>68382-0161-16</NDC11Code>
    <ProductNDC>68382-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090321</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules 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, (±)-. Its molecular and structural formula are. C16H21NO2·HCL. Propranolol hydrochloride, USP is white to off-white, crystalline powder; odorless and has a bitter taste. It melts at about 164oC. It is soluble in water and in alcohol; slightly soluble in chloroform and practically insoluble in ether. Its molecular weight is 295.80. Each propranolol hydrochloride extended-release capsule intended for oral administration contains 60 mg or 80 mg or 120 mg or 160 mg of propranolol hydrochloride. In addition, each capsule contains the following inactive ingredients: ethyl cellulose, FD&amp;C blue #1, gelatin, hypromellose, microcrystalline cellulose and titanium dioxide. Additionally each 60 mg, 80 mg and 120 mg capsule shell contains D&amp;C red # 28. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent. These capsules comply with USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-161-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (68462-161-90) </PackageDescription>
    <NDC11Code>68462-0161-90</NDC11Code>
    <ProductNDC>68462-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078170</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70436-161-06</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06) </PackageDescription>
    <NDC11Code>70436-0161-06</NDC11Code>
    <ProductNDC>70436-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213858</ApplicationNumber>
    <LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine Tartrate Extended-Release Capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</IndicationAndUsage>
    <Description>Tolterodine Tartrate Extended-Release Capsules, USP contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7,. Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each capsule contains 2 mg or 4 mg of tolterodine tartrate with the following inactive ingredients: ethylcellulose, hypromellose, medium-chain triglycerides, oleic acid, sugar spheres (composed of corn starch and sucrose) and talc. The capsule shell contains FD&amp;C Blue No.1, FD&amp;C Red No.40 (4 mg), gelatin, titanium dioxide and ferric oxide yellow (2 mg). The imprinting ink contains ferrosoferric oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-161-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (71205-161-90) </PackageDescription>
    <NDC11Code>71205-0161-90</NDC11Code>
    <ProductNDC>71205-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090510</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide, USP is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-161-60</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-161-60) </PackageDescription>
    <NDC11Code>71610-0161-60</NDC11Code>
    <ProductNDC>71610-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077118</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris. (1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).</IndicationAndUsage>
    <Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2- propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: cellulose acetate butyrate, corn starch, crospovidone, glyceryl monostearate, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, poloxamer 188, polyethylene glycol, polysorbate 80, sucrose, and titanium dioxide. Meets USP Dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-161-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (82804-161-90) </PackageDescription>
    <NDC11Code>82804-0161-90</NDC11Code>
    <ProductNDC>82804-161</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230912</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214344</ApplicationNumber>
    <LabelerName>Proficient Rx LP</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>2024-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241021</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 1 H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-, calcium salt (2:1), [R-(R*, R*)] trihydrate. The molecular formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca 2+3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white powder. Atorvastatin calcium is very slightly soluble in pH 1.2, pH 4.5 and pH 6.8 buffers; freely soluble in methanol; slightly soluble in ethanol; practically insoluble in acetonitrile. Atorvastatin Calcium Tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.825 mg, 21.649 mg, 43.299 mg or 86.579 mg atorvastatin calcium trihydrate, USP) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80 and film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. USP dissolution test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-016-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-016-90) </PackageDescription>
    <NDC11Code>42291-0016-90</NDC11Code>
    <ProductNDC>42291-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anastrozole</ProprietaryName>
    <NonProprietaryName>Anastrozole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079220</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ANASTROZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets (  1.3)  .</IndicationAndUsage>
    <Description>Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-027-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-027-90) </PackageDescription>
    <NDC11Code>42291-0027-90</NDC11Code>
    <ProductNDC>42291-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076846</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-036-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-036-90) </PackageDescription>
    <NDC11Code>42291-0036-90</NDC11Code>
    <ProductNDC>42291-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-037-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-037-90) </PackageDescription>
    <NDC11Code>42291-0037-90</NDC11Code>
    <ProductNDC>42291-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-038-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-038-90) </PackageDescription>
    <NDC11Code>42291-0038-90</NDC11Code>
    <ProductNDC>42291-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-039-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-039-90) </PackageDescription>
    <NDC11Code>42291-0039-90</NDC11Code>
    <ProductNDC>42291-039</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-040-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-040-90) </PackageDescription>
    <NDC11Code>42291-0040-90</NDC11Code>
    <ProductNDC>42291-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-041-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-041-90) </PackageDescription>
    <NDC11Code>42291-0041-90</NDC11Code>
    <ProductNDC>42291-041</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-045-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) </PackageDescription>
    <NDC11Code>42291-0045-90</NDC11Code>
    <ProductNDC>42291-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet:  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).  For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions.  Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-085-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) </PackageDescription>
    <NDC11Code>42291-0085-90</NDC11Code>
    <ProductNDC>42291-085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anastrozole</ProprietaryName>
    <NonProprietaryName>Anastrozole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078058</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ANASTROZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. (  1.3)  .</IndicationAndUsage>
    <Description>Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-101-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-101-90) </PackageDescription>
    <NDC11Code>42291-0101-90</NDC11Code>
    <ProductNDC>42291-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075047</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>