RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>21695-761-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21695-761-30)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>21695-0761-30</NDC11Code>
    <ProductNDC>21695-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nystatin</ProprietaryName>
    <NonProprietaryName>Nystatin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19930129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064022</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>NYSTATIN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Polyene Antifungal [EPC],Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.</IndicationAndUsage>
    <Description>Nystatin Cream is for dermatologic use. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Nystatin Cream contains the antifungal antibiotic nystatin at a concentration of 100,000 USP Nystatin Units per gram in an aqueous, perfumed cream base containing purified water, propylene glycol, methylparaben, propylparaben, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum hydroxide gel, titanium dioxide, sorbitol solution, and, if necessary, sodium hydroxide for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-761-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21695-761-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>21695-0761-15</NDC11Code>
    <ProductNDC>21695-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nystatin</ProprietaryName>
    <NonProprietaryName>Nystatin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19930129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064022</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>NYSTATIN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Polyene Antifungal [EPC],Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.</IndicationAndUsage>
    <Description>Nystatin Cream is for dermatologic use. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Nystatin Cream contains the antifungal antibiotic nystatin at a concentration of 100,000 USP Nystatin Units per gram in an aqueous, perfumed cream base containing purified water, propylene glycol, methylparaben, propylparaben, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum hydroxide gel, titanium dioxide, sorbitol solution, and, if necessary, sodium hydroxide for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-761-01</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (16714-761-01) </PackageDescription>
    <NDC11Code>16714-0761-01</NDC11Code>
    <ProductNDC>16714-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079019</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride, USP is the R(-) isomer as. determined by x-ray diffraction. and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine. hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride, USP is a white to off-white crystalline powder; sparingly soluble in water. Atomoxetine Capsules, USP are for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg. or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for Atomoxetine Capsules, USP 10 mg contains gelatin, and titanium dioxide. The capsule shell for Atomoxetine Capsules, USP 18 mg contains D&amp;C Yellow No. 10, FD&amp;C Yellow No. 6, gelatin. sodium lauryl sulfate, and titanium dioxide. The capsule shell for Atomoxetine Capsules, USP 25 mg and 40 mg contains D&amp;C Red No. 28, FD&amp;C Blue No.1. gelatin, and titanium dioxide. The capsule shell for Atomoxetine Capsules, USP 60 mg contains D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, FD&amp;C Red. No. 3, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The capsule shell for Atomoxetine Capsules, USP 80 mg and 100 mg contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1, gelatin, and titanium dioxide. The imprinting ink for Atomoxetine Capsules, USP 10 mg, 25 mg, 40 mg, 80 mg and 100 mg has the following. components: black iron oxide, D&amp;C Yellow No. 10, FD&amp;C Blue No. 2, FD&amp;C Blue No. 1, FD&amp;C Red No. 40. propylene glycol, and shellac. The imprinting ink for Atomoxetine Capsules, USP 18 mg and 60 mg has the following components: black iron. oxide, propylene glycol, potassium hydroxide, strong ammonia solution, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-761-30</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (40032-761-30)  &gt; 1 BLISTER PACK in 1 POUCH (40032-761-01)  &gt; 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>40032-0761-30</NDC11Code>
    <ProductNDC>40032-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204299</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem Tartrate is a GABAA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep (1). Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking (1).</IndicationAndUsage>
    <Description>Zolpidem Tartrate Sublingual Tablets contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem Tartrate Sublingual Tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem Tartrate Sublingual Tablets are intended to be placed under the tongue where they will disintegrate. Zolpidem Tartrate Sublingual Tablets contain a bicarbonate-carbonate buffer. Chemically, zolpidem tartrate is N,N-6-trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate (2:1). Zolpidem tartrate is a white to almost white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Sublingual Tablet includes the following inactive ingredients: Crospovidone, Povidone, Mannitol, Polyvinylacetate, colloidal silicon dioxide, sodium carbonate anhydrous, sodium bicarbonate, natural and artificial spearmint flavor, aspartame, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-761-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-761-30) </PackageDescription>
    <NDC11Code>43063-0761-30</NDC11Code>
    <ProductNDC>43063-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090939</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the:  treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1)  treatment of generalized anxiety disorder (GAD) in adults ( 1).</IndicationAndUsage>
    <Description>Escitalopram tablets contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1- [3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C 20H 21FN 2O  C 2H 2O 4and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets, USP are white to off-white, round, biconvex, film-coated tablets containing 6.38 mg, 12.75 mg and 25.55 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-761-30</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (43386-761-30)  &gt; 1 BLISTER PACK in 1 POUCH (43386-761-01)  &gt; 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>43386-0761-30</NDC11Code>
    <ProductNDC>43386-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204299</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>3.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2020-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem Tartrate is a GABA A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep ( 1). Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking (  1).</IndicationAndUsage>
    <Description>Zolpidem Tartrate Sublingual Tablets contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem Tartrate Sublingual Tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem Tartrate Sublingual Tablets are intended to be placed under the tongue where they will disintegrate. Zolpidem Tartrate Sublingual Tablets contain a bicarbonate-carbonate buffer. Chemically, zolpidem tartrate is N,N-6-trimethyl-2- p-tolylimidazo[1,2- α]pyridine-3-acetamide L-(+)-tartrate (2:1). Zolpidem tartrate is a white to almost white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Sublingual Tablet includes the following inactive ingredients: Crospovidone, Povidone, Mannitol, Polyvinylacetate, colloidal silicon dioxide, sodium carbonate anhydrous, sodium bicarbonate, natural and artificial spearmint flavor, aspartame, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>45802-761-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (45802-761-30)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>45802-0761-30</NDC11Code>
    <ProductNDC>45802-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250410</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209030</ApplicationNumber>
    <LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure. Mol. Formula: C26H32F2O7. Mol. Wt: 494.53. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 980, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. In the Fluocinonide Gel USP, 0.05% formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-761-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (46708-761-30) </PackageDescription>
    <NDC11Code>46708-0761-30</NDC11Code>
    <ProductNDC>46708-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217279</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>5; 80</StrengthNumber>
    <StrengthUnit>mg/1; 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], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.AmlodipineHypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 amlodipine. 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. Amlodipine may be used alone or in combination with other antihypertensive agents.Coronary Artery Disease (CAD)Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents.Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents.Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.Atorvastatin  Atorvastatin is 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>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate, USP with the HMG-CoA-reductase inhibitor atorvastatin calcium, USP. Amlodipine besylate, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro­ 6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium, USP is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl­4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate, USP and atorvastatin calcium, USP are shown below. Amlodipine besylate. Atorvastatin calcium. Amlodipine and atorvastatin tablets, USP contain amlodipine besylate, USP, a white or almost white powder, and atorvastatin calcium, USP, a white to off-white powder. Amlodipine besylate, USP has a molecular weight of 567.1 and atorvastatin calcium, USP has a molecular weight of 1209.42. Amlodipine besylate, USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Atorvastatin calcium, USP is freely soluble in methanol, slightly soluble in ethanol, very slightly soluble in water and in pH 7.4 phosphate buffer, insoluble in aqueous solution of pH 4 and in acetonitrile. Amlodipine and atorvastatin tablets, USP are available as film-coated tablets for oral administration containing.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin  calcium, USP. Each film-coated tablet also contains calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Additionally 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg also contains FD&amp;C Blue #2 Aluminum Lake. Amlodipine and atorvastatin tablets, USP meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49973-761-30</NDCCode>
    <PackageDescription>15 BLISTER PACK in 1 BOX (49973-761-30)  &gt; 2 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>49973-0761-30</NDC11Code>
    <ProductNDC>49973-761</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Azo Urinary Pain Relief</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>i-Health, Inc.</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52959-761-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (52959-761-30)</PackageDescription>
    <NDC11Code>52959-0761-30</NDC11Code>
    <ProductNDC>52959-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonazepam</ProprietaryName>
    <NonProprietaryName>Clonazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074869</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>CLONAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&amp;C Red #30 aluminum lake. The 1 mg tablet also contains D&amp;C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-761-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-761-30) </PackageDescription>
    <NDC11Code>55289-0761-30</NDC11Code>
    <ProductNDC>55289-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040326</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55700-761-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (55700-761-30) </PackageDescription>
    <NDC11Code>55700-0761-30</NDC11Code>
    <ProductNDC>55700-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <EndMarketingDate>20271130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207402</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules 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>Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&amp;C Blue 1, D&amp;C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&amp;C Blue 1, D&amp;C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&amp;C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint  SW-0012 White Ink. Composition of imprinting ink [TekPrint  SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α-D- galacto-octopyranoside monohydrochloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-761-00</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (59088-761-00)  *  9 CAPSULE in 1 BOTTLE (50436-0383-9)  *  1 TUBE in 1 CARTON (52565-007-30)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>59088-0761-00</NDC11Code>
    <ProductNDC>59088-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipritin Ii</ProprietaryName>
    <NonProprietaryName>Gabapentin, Lidocaine And Prilocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204989</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59427-761-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (59427-761-02)  &gt; 30 mL in 1 BOTTLE (59427-761-01)</PackageDescription>
    <NDC11Code>59427-0761-02</NDC11Code>
    <ProductNDC>59427-761</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nude And Improved Bare Face Makeup</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ORIGINS NATURAL RESOURCES INC.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7.6</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60760-761-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-761-30) </PackageDescription>
    <NDC11Code>60760-0761-30</NDC11Code>
    <ProductNDC>60760-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070423</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077322</ApplicationNumber>
    <LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250807</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Zolpidem tartrate is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet contains either 5 mg or 10 mg zolpidem tartrate with the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, titanium dioxide, carnauba wax; the 10-mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-761-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-761-30) </PackageDescription>
    <NDC11Code>61919-0761-30</NDC11Code>
    <ProductNDC>61919-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate Er</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate Er</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204106</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Hypertension. Metoprolol succinate extended-release tablets 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 metoprolol. 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. Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents. 1.2 Angina Pectoris. Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. 1.3 Heart Failure. Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.</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. [image-01]. Metoprolol succinate, USP 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: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-761-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-761-30) </PackageDescription>
    <NDC11Code>62332-0761-30</NDC11Code>
    <ProductNDC>62332-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217279</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>5; 80</StrengthNumber>
    <StrengthUnit>mg/1; 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], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.AmlodipineHypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 amlodipine. 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. Amlodipine may be used alone or in combination with other antihypertensive agents.Coronary Artery Disease (CAD)Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents.Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents.Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.Atorvastatin  Atorvastatin is 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>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate, USP with the HMG-CoA-reductase inhibitor atorvastatin calcium, USP. Amlodipine besylate, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro­ 6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium, USP is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl­4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate, USP and atorvastatin calcium, USP are shown below. Amlodipine besylate. Atorvastatin calcium. Amlodipine and atorvastatin tablets, USP contain amlodipine besylate, USP, a white or almost white powder, and atorvastatin calcium, USP, a white to off-white powder. Amlodipine besylate, USP has a molecular weight of 567.1 and atorvastatin calcium, USP has a molecular weight of 1209.42. Amlodipine besylate, USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Atorvastatin calcium, USP is freely soluble in methanol, slightly soluble in ethanol, very slightly soluble in water and in pH 7.4 phosphate buffer, insoluble in aqueous solution of pH 4 and in acetonitrile. Amlodipine and atorvastatin tablets, USP are available as film-coated tablets for oral administration containing.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin  calcium, USP.  10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin  calcium, USP. Each film-coated tablet also contains calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Additionally 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg also contains FD&amp;C Blue #2 Aluminum Lake. Amlodipine and atorvastatin tablets, USP meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62756-761-83</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (62756-761-83)</PackageDescription>
    <NDC11Code>62756-0761-83</NDC11Code>
    <ProductNDC>62756-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Torsemide</ProprietaryName>
    <NonProprietaryName>Torsemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078478</ApplicationNumber>
    <LabelerName>SUN PHARMACEUTICAL INDUSTRIES LIMITED</LabelerName>
    <SubstanceName>TORSEMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63187-761-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-30) </PackageDescription>
    <NDC11Code>63187-0761-30</NDC11Code>
    <ProductNDC>63187-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074514</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
    <Description>Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65841-761-06</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-06) </PackageDescription>
    <NDC11Code>65841-0761-06</NDC11Code>
    <ProductNDC>65841-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091352</ApplicationNumber>
    <LabelerName>Zydus Lifesciences 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>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66096-761-02</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-761-02) </PackageDescription>
    <NDC11Code>66096-0761-02</NDC11Code>
    <ProductNDC>66096-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ohm-resb</ProprietaryName>
    <NonProprietaryName>Aconitum, Aranea, Bryonia, Equisetum, Eupatorium Perf, Hydrastis, Juglans Reg, Kali Bic, Phosphorus, Sarsaparrilla, Sulphur</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181219</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>OHM PHARMA INC.</LabelerName>
    <SubstanceName>ACONITUM NAPELLUS; ARANEUS DIADEMATUS; BRYONIA ALBA ROOT; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GOLDENSEAL; JUGLANS REGIA LEAF; POTASSIUM DICHROMATE; PHOSPHORUS; SARSAPARILLA</SubstanceName>
    <StrengthNumber>6; 9; 6; 7; 5; 7; 6; 12; 7; 9</StrengthNumber>
    <StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USES: Temporarily relieves lower respiratory track mucosa irritation or secretion due to diverse etiology.**.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67457-762-30</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (67457-762-30)  *  6 mL in 1 VIAL (67457-760-30)  *  2 mL in 1 SYRINGE (67457-761-02) </PackageDescription>
    <NDC11Code>67457-0762-30</NDC11Code>
    <ProductNDC>67457-762</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Octreotide Acetate</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216589</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated.</IndicationAndUsage>
    <Description>Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is. Octreotide acetate for injectable suspension is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. Octreotide acetate for injectable suspension is available as: sterile 6 mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of octreotide acetate for injectable suspension delivers.</Description>
  </NDC>
  <NDC>
    <NDCCode>68180-761-06</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (68180-761-06) </PackageDescription>
    <NDC11Code>68180-0761-06</NDC11Code>
    <ProductNDC>68180-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nadolol</ProprietaryName>
    <NonProprietaryName>Nadolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171005</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209309</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NADOLOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nadolol Tablets are indicated for the long-term management of patients with angina pectoris.</IndicationAndUsage>
    <Description>Nadolol Tablet USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula. Nadolol is a white to off-white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol Tablet USP is available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, corn starch, FD&amp;C Blue No. 2-aluminium lake, magnesium stearate, microcrystalline cellulose, povidone, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-761-30</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68462-761-30)  / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68462-0761-30</NDC11Code>
    <ProductNDC>68462-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinephrine</ProprietaryName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219239</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>EPINEPHRINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: 1 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.1) , 2 For emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.2) .</IndicationAndUsage>
    <Description>Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine. 10 mL Multiple-Dose Vial:10 mL multiple-dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 10 mL vial, each 1 mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. 30 mL Multiple Dose Vial:. 30 mL multiple dose amber glass vial containing 30 mg/30 mL epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 30 mL vial, each 1 mL of Epinephrine Injection USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-761-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-761-30) </PackageDescription>
    <NDC11Code>71205-0761-30</NDC11Code>
    <ProductNDC>71205-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078494</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230209</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, USP 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 formulae are. C16H21NO2·HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar spheres, talc, titanium dioxide. In addition, the 60 mg and 80 mg capsule shells contain yellow iron oxide. The 120 mg capsule shells contain black iron oxide and yellow iron oxide. The 160 mg capsule shells contain black iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or Opacode S-1-8115 black contains: D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide. This drug product complies with USP Drug Release Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-761-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71610-761-30) </PackageDescription>
    <NDC11Code>71610-0761-30</NDC11Code>
    <ProductNDC>71610-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040188</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of UseCarisoprodol should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Carisoprodol tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture.Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol drug product include hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-761-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (76420-761-30) </PackageDescription>
    <NDC11Code>76420-0761-30</NDC11Code>
    <ProductNDC>76420-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091490</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride, USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>81110-761-02</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (81110-761-02)  / 30 mL in 1 BOTTLE, DROPPER (81110-761-01) </PackageDescription>
    <NDC11Code>81110-0761-02</NDC11Code>
    <ProductNDC>81110-761</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ilia Super Serum Skin Tint (st13 Kamari)</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Ilia, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>132</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-761-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-761-01)  / 3 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0761-01</NDC11Code>
    <ProductNDC>10237-761</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Cold Sore Moisturelock</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>BENZOCAINE; ALLANTOIN; CAMPHOR (NATURAL); DIMETHICONE; MENTHOL; PETROLATUM</SubstanceName>
    <StrengthNumber>200; 5; 30; 20; 10; 640</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses temporarily relieves pain and dryness; softens crusts (scabs) associated with  cold sores  fever blisters.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-761-12</NDCCode>
    <PackageDescription>120 g in 1 BOTTLE (13668-761-12) </PackageDescription>
    <NDC11Code>13668-0761-12</NDC11Code>
    <ProductNDC>13668-761</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Icosapent Ethyl</ProprietaryName>
    <NonProprietaryName>Icosapent Ethyl Capsules</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218994</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ICOSAPENT ETHYL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL)hypertriglyceridemia.</IndicationAndUsage>
    <Description>Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram liquid-filled soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is (5Z, 8Z, 11Z, 14Z, 17Z)-Eicosa-5, 8, 11, 14, 17-Pentaenoic Acid Ethyl Ester with the following chemical structure. Icosapent ethyl capsules contain the following inactive ingredients: dl-alpha tocopherol, gelatin, glycerin, sorbitol sorbitan solution, and purified water.</Description>
  </NDC>
</NDCList>