RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>42291-568-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-568-90) </PackageDescription>
    <NDC11Code>42291-0568-90</NDC11Code>
    <ProductNDC>42291-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207515</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>18</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14)] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
    <Description>Methylphenidate HCl extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate HCl extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl, USP is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release tablets, USP also contains the following inert ingredients: colloidal silicon dioxide, ethylcellulose, fumaric acid, hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium chloride, stearic acid, talc, titanium dioxide and triethyl citrate. The 18 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 27 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 54 mg extended-release tablet also contains iron oxide red. USP dissolution test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>45963-568-08</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (45963-568-08) </PackageDescription>
    <NDC11Code>45963-0568-08</NDC11Code>
    <ProductNDC>45963-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170426</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202968</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 80</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170426</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>49999-568-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (49999-568-90)</PackageDescription>
    <NDC11Code>49999-0568-90</NDC11Code>
    <ProductNDC>49999-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078428</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-08</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51655-568-26</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-568-26) </PackageDescription>
    <NDC11Code>51655-0568-26</NDC11Code>
    <ProductNDC>51655-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074726</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>The potassium chloride extended-release tablets, USP product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-568-90</NDCCode>
    <PackageDescription>45 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-568-90) </PackageDescription>
    <NDC11Code>51655-0568-90</NDC11Code>
    <ProductNDC>51655-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074726</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
    <Description>The potassium chloride extended-release tablets, USP product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-568-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-568-90) </PackageDescription>
    <NDC11Code>60760-0568-90</NDC11Code>
    <ProductNDC>60760-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204720</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-05-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Glipizide extended-release tablets contain glipizide which is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red ferric oxide, cellulose acetate, polyethylene glycol, Opadry ® blue (OY-LS-20921) (hypromellose, lactose monohydrate, titanium dioxide, triacetin and FD&amp;C blue#2) (2.5 mg tablets), Opadry ® white (YS-2-7063) (hypromellose, titanium dioxide and polyethylene glycol) (5 mg and 10 mg tablet) and Opacode ® Black Ink (S-1-277001) (shellac, ferrosoferric oxide, propylene glycol). System Components and PerformanceGlipizide extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet. The function of the glipizide extended-release tablets depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-568-90</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-568-90)  &gt; .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0568-90</NDC11Code>
    <ProductNDC>63323-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150220</StartMarketingDate>
    <EndMarketingDate>20221130</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-568-90</NDCCode>
    <PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (65862-568-90) </PackageDescription>
    <NDC11Code>65862-0568-90</NDC11Code>
    <ProductNDC>65862-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202096</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium is a leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1)., 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2)., 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).</IndicationAndUsage>
    <Description>Montelukast sodium, the active ingredient in montelukast sodium tablets and montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2­-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The molecular formula is C35H35ClNNaO3S, and its molecular weight is 608.18. The structural formula is. Montelukast sodium USP is a hygroscopic, optically active, off-white to pale yellow colored powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10 mg film-coated montelukast sodium tablet USP contains 10.38 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each 4 mg and 5 mg montelukast sodium chewable tablet USP contains 4.15 mg and 5.19 mg montelukast sodium USP, respectively, which are equivalent to 4 mg and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: artificial cherry flavor, aspartame, croscarmellose sodium, ferric oxide, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>67544-568-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (67544-568-60)</PackageDescription>
    <NDC11Code>67544-0568-60</NDC11Code>
    <ProductNDC>67544-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19910313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070086</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains: : 1   Furosemide . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-568-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68462-568-90) </PackageDescription>
    <NDC11Code>68462-0568-90</NDC11Code>
    <ProductNDC>68462-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207807</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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>2024-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are 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 (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP &lt;140 mmHg or &lt;130 mmHg or a DBP &lt;90 mmHg or &lt;80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 51% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 60% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
    <Description>Amlodipine and Olmesartan Medoxomil Tablets, USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. Amlodipine and Olmesartan Medoxomil Tablets, USP contain amlodipine besylate, USP and olmesartan medoxomil, 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-pyridine dicarboxylate, monobenzenesulphonate. It is a white to off-white crystalline powder that is freely soluble in methanol, sparingly soluble in alcohol and slightly soluble in water and 2-propanol. The molecular formula and weight of amlodipine besylate, USP are C20H25ClN2O5C6H6O3S and 567.05 g/mol. It has the following structural formula. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, USP is chemically described as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl] methyl]-(5-methyl-2-oxo-1,3-dioxol-4-yl) methyl ester. It is a white to off-white crystalline powder that is sparingly soluble in methanol, practically insoluble in water, slightly soluble in acetone, and very slightly soluble in ethanol. The molecular formula and weight of olmesartan medoxomil, USP are C29H30N6O6 and 558.59 g/mol. It has the following structural formula:. Each tablet of Amlodipine and Olmesartan Medoxomil Tablets, USP also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. The color coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol 3350, talc, and titanium dioxide. The 5 mg/40 mg tablets also contain iron oxide yellow. The 10 mg/20 mg tablets and 10 mg/40 mg tablets also contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-568-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71205-568-90) </PackageDescription>
    <NDC11Code>71205-0568-90</NDC11Code>
    <ProductNDC>71205-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071523</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
    <Description>Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water.  The structural formula is represented as follows. C19H22CIN5O  HCl M.W. 408.32. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-568-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (76282-568-90) </PackageDescription>
    <NDC11Code>76282-0568-90</NDC11Code>
    <ProductNDC>76282-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211384</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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, USP along with pregelatinized starch, corn starch and talc as inactive ingredients. Capsule shells for 25 mg, 50 mg &amp; 150 mg contains: gelatin &amp; titanium dioxide. Capsule shells for 75 mg, 100 mg, 200 mg, 225 mg &amp; 300 mg contains: gelatin, FD&amp;C Blue No.1, FD&amp;C Red No.40, FD&amp;C Yellow No.6 and titanium dioxide. Imprinting ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-568-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (76420-568-90) </PackageDescription>
    <NDC11Code>76420-0568-90</NDC11Code>
    <ProductNDC>76420-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Np Thyroid 60</ProprietaryName>
    <NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101111</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
    <StrengthNumber>38; 9</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230516</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
    <Description>NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>83566-568-01</NDCCode>
    <PackageDescription>90 g in 1 BOTTLE (83566-568-01) </PackageDescription>
    <NDC11Code>83566-0568-01</NDC11Code>
    <ProductNDC>83566-568</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rosehip Oil</ProprietaryName>
    <NonProprietaryName>Rosa Canina Fruit Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240808</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Guangzhou Yilong Cosmetics Co., Ltd</LabelerName>
    <SubstanceName>ROSA CANINA FRUIT OIL</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Step 1: Clean and thoroughly dry the skin. Step 2: Twist the bottle cap to open the product. Step 3: Gently apply to the skin or other desired areas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16571-826-09</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (16571-826-09) </PackageDescription>
    <NDC11Code>16571-0826-09</NDC11Code>
    <ProductNDC>16571-826</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolmetin Sodium</ProprietaryName>
    <NonProprietaryName>Tolmetin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <EndMarketingDate>20260531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073393</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>TOLMETIN SODIUM</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of tolmetin sodium capsules, USP and other treatment options before deciding to use tolmetin sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium capsules have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Each capsule for oral administration contains 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The empty gelatin capsule shells contain FD&amp;C Blue No. 1, gelatin, and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is. Sodium 1-methyl-5 p-toluoylpyrrole-2-acetate dihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-568-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-568-01)  / 1 TABLET in 1 BLISTER PACK (60687-568-11) </PackageDescription>
    <NDC11Code>60687-0568-01</NDC11Code>
    <ProductNDC>60687-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methocarbamol</ProprietaryName>
    <NonProprietaryName>Methocarbamol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200520</StartMarketingDate>
    <EndMarketingDate>20271231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090200</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>METHOCARBAMOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200520</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-568-14</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68462-568-14)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0568-14</NDC11Code>
    <ProductNDC>68462-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207807</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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>2024-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are 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 (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP &lt;140 mmHg or &lt;130 mmHg or a DBP &lt;90 mmHg or &lt;80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 51% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 60% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
    <Description>Amlodipine and Olmesartan Medoxomil Tablets, USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. Amlodipine and Olmesartan Medoxomil Tablets, USP contain amlodipine besylate, USP and olmesartan medoxomil, 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-pyridine dicarboxylate, monobenzenesulphonate. It is a white to off-white crystalline powder that is freely soluble in methanol, sparingly soluble in alcohol and slightly soluble in water and 2-propanol. The molecular formula and weight of amlodipine besylate, USP are C20H25ClN2O5C6H6O3S and 567.05 g/mol. It has the following structural formula. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, USP is chemically described as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl] methyl]-(5-methyl-2-oxo-1,3-dioxol-4-yl) methyl ester. It is a white to off-white crystalline powder that is sparingly soluble in methanol, practically insoluble in water, slightly soluble in acetone, and very slightly soluble in ethanol. The molecular formula and weight of olmesartan medoxomil, USP are C29H30N6O6 and 558.59 g/mol. It has the following structural formula:. Each tablet of Amlodipine and Olmesartan Medoxomil Tablets, USP also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. The color coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol 3350, talc, and titanium dioxide. The 5 mg/40 mg tablets also contain iron oxide yellow. The 10 mg/20 mg tablets and 10 mg/40 mg tablets also contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-568-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68462-568-30) </PackageDescription>
    <NDC11Code>68462-0568-30</NDC11Code>
    <ProductNDC>68462-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
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    <StartMarketingDate>20170705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207807</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>5; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are 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 (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP &lt;140 mmHg or &lt;130 mmHg or a DBP &lt;90 mmHg or &lt;80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 51% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 60% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
    <Description>Amlodipine and Olmesartan Medoxomil Tablets, USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. Amlodipine and Olmesartan Medoxomil Tablets, USP contain amlodipine besylate, USP and olmesartan medoxomil, 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-pyridine dicarboxylate, monobenzenesulphonate. It is a white to off-white crystalline powder that is freely soluble in methanol, sparingly soluble in alcohol and slightly soluble in water and 2-propanol. The molecular formula and weight of amlodipine besylate, USP are C20H25ClN2O5C6H6O3S and 567.05 g/mol. It has the following structural formula. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, USP is chemically described as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl] methyl]-(5-methyl-2-oxo-1,3-dioxol-4-yl) methyl ester. It is a white to off-white crystalline powder that is sparingly soluble in methanol, practically insoluble in water, slightly soluble in acetone, and very slightly soluble in ethanol. The molecular formula and weight of olmesartan medoxomil, USP are C29H30N6O6 and 558.59 g/mol. It has the following structural formula:. Each tablet of Amlodipine and Olmesartan Medoxomil Tablets, USP also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. The color coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol 3350, talc, and titanium dioxide. The 5 mg/40 mg tablets also contain iron oxide yellow. The 10 mg/20 mg tablets and 10 mg/40 mg tablets also contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-016-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-016-90) </PackageDescription>
    <NDC11Code>42291-0016-90</NDC11Code>
    <ProductNDC>42291-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anastrozole</ProprietaryName>
    <NonProprietaryName>Anastrozole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079220</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ANASTROZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets (  1.3)  .</IndicationAndUsage>
    <Description>Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-027-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-027-90) </PackageDescription>
    <NDC11Code>42291-0027-90</NDC11Code>
    <ProductNDC>42291-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076846</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-036-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-036-90) </PackageDescription>
    <NDC11Code>42291-0036-90</NDC11Code>
    <ProductNDC>42291-036</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
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    <NDCCode>42291-037-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-037-90) </PackageDescription>
    <NDC11Code>42291-0037-90</NDC11Code>
    <ProductNDC>42291-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-038-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-038-90) </PackageDescription>
    <NDC11Code>42291-0038-90</NDC11Code>
    <ProductNDC>42291-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-039-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-039-90) </PackageDescription>
    <NDC11Code>42291-0039-90</NDC11Code>
    <ProductNDC>42291-039</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-040-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-040-90) </PackageDescription>
    <NDC11Code>42291-0040-90</NDC11Code>
    <ProductNDC>42291-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-041-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-041-90) </PackageDescription>
    <NDC11Code>42291-0041-90</NDC11Code>
    <ProductNDC>42291-041</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202830</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-045-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) </PackageDescription>
    <NDC11Code>42291-0045-90</NDC11Code>
    <ProductNDC>42291-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204598</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet:  To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1).  For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions.  Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2 / indigo caramine aluminum lake, FD&amp;C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-085-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) </PackageDescription>
    <NDC11Code>42291-0085-90</NDC11Code>
    <ProductNDC>42291-085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anastrozole</ProprietaryName>
    <NonProprietaryName>Anastrozole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078058</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ANASTROZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. (  1.3)  .</IndicationAndUsage>
    <Description>Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-101-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-101-90) </PackageDescription>
    <NDC11Code>42291-0101-90</NDC11Code>
    <ProductNDC>42291-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075047</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42291-102-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42291-102-90) </PackageDescription>
    <NDC11Code>42291-0102-90</NDC11Code>
    <ProductNDC>42291-102</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075047</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>