RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>42806-645-05</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (42806-645-05) </PackageDescription>
    <NDC11Code>42806-0645-05</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-645-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (42806-645-01) </PackageDescription>
    <NDC11Code>42806-0645-01</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-645-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (42806-645-60) </PackageDescription>
    <NDC11Code>42806-0645-60</NDC11Code>
    <ProductNDC>42806-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214207</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
    <Description>Doxycycline Hyclate Tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 · HCl)2 ·C2H6O·H2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP are available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Inactive ingredients in the tablet formulation are: carnauba wax, croscarmellose sodium, FD&amp;C Blue #1 Aluminum Lake (75 mg Tablet), FD&amp;C Blue #2 Aluminum Lake (150 mg Tablet), FD&amp;C Yellow #6 Aluminum Lake (75 mg Tablet), iron oxide yellow (150 mg Tablet), macrogol/PEG, magnesium stearate, NF (vegetable grade), microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, purified water, sodium lauryl sulfate, talc, titanium dioxide. Doxycycline hyclate tablets USP, 75 mg contain 0.128 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets USP, 150 mg contain 0.256 mg (0.0111 mEq) of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>10135-645-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (10135-645-05) </PackageDescription>
    <NDC11Code>10135-0645-05</NDC11Code>
    <ProductNDC>10135-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204989</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for: : 1 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C Red 40, D&amp;C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&amp;C Yellow 10, and FD&amp;C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>12213-800-05</NDCCode>
    <PackageDescription>645.5 L in 1 CYLINDER (12213-800-05) </PackageDescription>
    <NDC11Code>12213-0800-05</NDC11Code>
    <ProductNDC>12213-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbon Dioxide/oxygen Mix</ProprietaryName>
    <NonProprietaryName>Carbon Dioxide/oxygen Mix</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19960601</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205849</ApplicationNumber>
    <LabelerName>NEXAIR, LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50228-645-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (50228-645-05) </PackageDescription>
    <NDC11Code>50228-0645-05</NDC11Code>
    <ProductNDC>50228-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>ScieGen Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-645-05</NDCCode>
    <PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05) </PackageDescription>
    <NDC11Code>55111-0645-05</NDC11Code>
    <ProductNDC>55111-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078490</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>40</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>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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 empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP 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: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells have the following inactive ingredients: black iron oxide, D &amp; C Red 28, FD &amp; C Blue 1, FD &amp; C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-645-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-645-05) </PackageDescription>
    <NDC11Code>68382-0645-05</NDC11Code>
    <ProductNDC>68382-645</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205192</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).</IndicationAndUsage>
    <Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablet is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, stearic acid, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-645-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-645-05) </PackageDescription>
    <NDC11Code>68428-0645-05</NDC11Code>
    <ProductNDC>68428-645</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stannum Iodatum</ProprietaryName>
    <NonProprietaryName>Stannous Iodide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100212</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>STANNOUS IODIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42806-011-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-011-05) </PackageDescription>
    <NDC11Code>42806-0011-05</NDC11Code>
    <ProductNDC>42806-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulindac</ProprietaryName>
    <NonProprietaryName>Sulindac</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072711</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>SULINDAC</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).</IndicationAndUsage>
    <Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-018-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-018-05) </PackageDescription>
    <NDC11Code>42806-0018-05</NDC11Code>
    <ProductNDC>42806-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulindac</ProprietaryName>
    <NonProprietaryName>Sulindac</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072710</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>SULINDAC</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following. 1. Osteoarthritis. 2. Rheumatoid arthritis**. 3. Ankylosing spondylitis. 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis). 5. Acute gouty arthritis. **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).</IndicationAndUsage>
    <Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-019-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-019-05)</PackageDescription>
    <NDC11Code>42806-0019-05</NDC11Code>
    <ProductNDC>42806-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42806-020-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-020-05)</PackageDescription>
    <NDC11Code>42806-0020-05</NDC11Code>
    <ProductNDC>42806-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42806-021-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-021-05)</PackageDescription>
    <NDC11Code>42806-0021-05</NDC11Code>
    <ProductNDC>42806-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42806-048-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-048-05) </PackageDescription>
    <NDC11Code>42806-0048-05</NDC11Code>
    <ProductNDC>42806-048</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guanfacine</ProprietaryName>
    <NonProprietaryName>Guanfacine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131202</StartMarketingDate>
    <EndMarketingDate>20180930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074673</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20131202</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42806-049-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-049-05) </PackageDescription>
    <NDC11Code>42806-0049-05</NDC11Code>
    <ProductNDC>42806-049</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guanfacine</ProprietaryName>
    <NonProprietaryName>Guanfacine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131202</StartMarketingDate>
    <EndMarketingDate>20180731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074673</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20131202</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42806-055-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-055-05) </PackageDescription>
    <NDC11Code>42806-0055-05</NDC11Code>
    <ProductNDC>42806-055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078552</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>2.5</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>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110425</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)oAmlodipine besylate 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate 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 empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-056-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-056-05) </PackageDescription>
    <NDC11Code>42806-0056-05</NDC11Code>
    <ProductNDC>42806-056</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078552</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</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>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110425</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)oAmlodipine besylate 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate 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 empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-057-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-057-05) </PackageDescription>
    <NDC11Code>42806-0057-05</NDC11Code>
    <ProductNDC>42806-057</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078552</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</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>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110425</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)oAmlodipine besylate 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., 2 Coronary Artery Disease (1.2)oChronic Stable AnginaoVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate 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 empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate and magnesium stearate. Meet USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-081-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) </PackageDescription>
    <NDC11Code>42806-0081-05</NDC11Code>
    <ProductNDC>42806-081</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090346</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below:. Each film-coated tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: crospovidone, carnauba wax, FD&amp;C Red #40, FD&amp;C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, silicon dioxide, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-082-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-082-05) </PackageDescription>
    <NDC11Code>42806-0082-05</NDC11Code>
    <ProductNDC>42806-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-083-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-083-05) </PackageDescription>
    <NDC11Code>42806-0083-05</NDC11Code>
    <ProductNDC>42806-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-084-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-084-05) </PackageDescription>
    <NDC11Code>42806-0084-05</NDC11Code>
    <ProductNDC>42806-084</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-085-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-085-05) </PackageDescription>
    <NDC11Code>42806-0085-05</NDC11Code>
    <ProductNDC>42806-085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-086-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-086-05) </PackageDescription>
    <NDC11Code>42806-0086-05</NDC11Code>
    <ProductNDC>42806-086</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-087-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-087-05) </PackageDescription>
    <NDC11Code>42806-0087-05</NDC11Code>
    <ProductNDC>42806-087</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040275</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol tablets are indicated in the: 1 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies).</IndicationAndUsage>
    <Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-088-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-088-05) </PackageDescription>
    <NDC11Code>42806-0088-05</NDC11Code>
    <ProductNDC>42806-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040275</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol tablets are indicated in the: 1 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies).</IndicationAndUsage>
    <Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-089-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42806-089-05) </PackageDescription>
    <NDC11Code>42806-0089-05</NDC11Code>
    <ProductNDC>42806-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040275</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol tablets are indicated in the: 1 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies).</IndicationAndUsage>
    <Description>Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-143-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-143-05) </PackageDescription>
    <NDC11Code>42806-0143-05</NDC11Code>
    <ProductNDC>42806-143</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Demeclocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Demeclocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065447</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>DEMECLOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Demeclocycline hydrochloride tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae; Lymphogranuloma venereum due to Chlamydia trachomatis; Psittacosis (Ornithosis) due to Chlamydia psittaci; Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia trachomatis; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis; Relapsing fever due to Borrelia recurrentis;Chancroid caused by Haemophilus ducreyi;. Plague due to Yersinia pestis;. Tularemia due to Francisella tularensis;. Cholera caused by Vibrio cholerae;. Campylobacter fetus infections caused by Campylobacter fetus;. Brucellosis due to Brucella species (in conjunction with streptomycin);. Bartonellosis due to Bartonella bacilliformis;. Granuloma inguinale caused by Calymmatobacterium granulomatis;. Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli;. Enterobacter aerogenes;. Shigella species;. Acinetobacter species;. Respiratory tract infections caused by Haemophilus influenzae;. Respiratory tract and urinary tract infections caused by Klebsiella species. Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae;. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae;. Syphilis caused by Treponema pallidum subspecies pallidum;. Yaws caused by Treponema pallidum subspecies pertenue;. Listeriosis due to Listeria monocytogenes;. Anthrax due to Bacillus anthracis;. Vincent’s infection caused by Fusobacterium fusiforme;. Actinomycosis caused by Actinomyces israelii;. Clostridial diseases caused by Clostridium species. In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides. In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Demeclocycline hydrochloride, USP is an antibiotic isolated from a mutant strain of Streptomyces aureofaciens. Chemically it is 7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12, 12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is. Each film-coated tablet, for oral administration contains 150 mg or 300 mg of demeclocycline hydrochloride, USP and has the following inactive ingredients: carnauba wax, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromelloses, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin, D&amp;C Red No. 27 Aluminum Lake, D&amp;C Red No. 30 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake and FD&amp;C Yellow No. 6 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-159-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-159-05) </PackageDescription>
    <NDC11Code>42806-0159-05</NDC11Code>
    <ProductNDC>42806-159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040604</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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. C21H27CIN2O2·2HCl. M.W. 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 carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&amp;C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&amp;C Blue #2 Aluminum Lake (25 mg), FD&amp;C Red #40 Aluminum Lake (50 mg), FD&amp;C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).</Description>
  </NDC>
</NDCList>