RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>58151-236-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-236-77) </PackageDescription>
    <NDC11Code>58151-0236-77</NDC11Code>
    <ProductNDC>58151-236</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-103-77</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-77) </PackageDescription>
    <NDC11Code>58151-0103-77</NDC11Code>
    <ProductNDC>58151-103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Detrol La</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240110</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021228</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240110</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. DETROL LA 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&amp;C Blue #2. DETROL LA 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&amp;C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-104-77</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-77) </PackageDescription>
    <NDC11Code>58151-0104-77</NDC11Code>
    <ProductNDC>58151-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Detrol La</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240320</StartMarketingDate>
    <EndMarketingDate>20260731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021228</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240320</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. DETROL LA 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&amp;C Blue #2. DETROL LA 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&amp;C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-125-77</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-125-77) </PackageDescription>
    <NDC11Code>58151-0125-77</NDC11Code>
    <ProductNDC>58151-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Effexor</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240717</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020699</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-126-77</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-126-77) </PackageDescription>
    <NDC11Code>58151-0126-77</NDC11Code>
    <ProductNDC>58151-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Effexor</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241030</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020699</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-127-77</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-127-77) </PackageDescription>
    <NDC11Code>58151-0127-77</NDC11Code>
    <ProductNDC>58151-127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Effexor</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020699</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-155-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (58151-155-77) </PackageDescription>
    <NDC11Code>58151-0155-77</NDC11Code>
    <ProductNDC>58151-155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipitor</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020702</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-156-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (58151-156-77) </PackageDescription>
    <NDC11Code>58151-0156-77</NDC11Code>
    <ProductNDC>58151-156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipitor</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240220</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020702</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-157-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (58151-157-77) </PackageDescription>
    <NDC11Code>58151-0157-77</NDC11Code>
    <ProductNDC>58151-157</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipitor</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240103</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020702</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-158-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (58151-158-77) </PackageDescription>
    <NDC11Code>58151-0158-77</NDC11Code>
    <ProductNDC>58151-158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lipitor</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240229</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020702</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIPITOR is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>LIPITOR (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. LIPITOR tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
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  <NDC>
    <NDCCode>58151-237-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-237-77) </PackageDescription>
    <NDC11Code>58151-0237-77</NDC11Code>
    <ProductNDC>58151-237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-238-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-238-77) </PackageDescription>
    <NDC11Code>58151-0238-77</NDC11Code>
    <ProductNDC>58151-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250617</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-239-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-239-77) </PackageDescription>
    <NDC11Code>58151-0239-77</NDC11Code>
    <ProductNDC>58151-239</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241022</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-240-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-240-77) </PackageDescription>
    <NDC11Code>58151-0240-77</NDC11Code>
    <ProductNDC>58151-240</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-241-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-241-77) </PackageDescription>
    <NDC11Code>58151-0241-77</NDC11Code>
    <ProductNDC>58151-241</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250605</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-242-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-242-77) </PackageDescription>
    <NDC11Code>58151-0242-77</NDC11Code>
    <ProductNDC>58151-242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250710</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-243-77</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (58151-243-77) </PackageDescription>
    <NDC11Code>58151-0243-77</NDC11Code>
    <ProductNDC>58151-243</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250508</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250508</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LYRICA is 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 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 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. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-353-77</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (58151-353-77) </PackageDescription>
    <NDC11Code>58151-0353-77</NDC11Code>
    <ProductNDC>58151-353</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norvasc</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019787</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NORVASC is 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)oNORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)oChronic Stable Angina oVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>NORVASC is the besylate salt of amlodipine, a long‑acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4‑(2‑chlorophenyl)‑1,4‑dihydro‑6‑methyl‑3,5‑pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-354-77</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (58151-354-77) </PackageDescription>
    <NDC11Code>58151-0354-77</NDC11Code>
    <ProductNDC>58151-354</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norvasc</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240924</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019787</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NORVASC is 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)oNORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)oChronic Stable Angina oVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>NORVASC is the besylate salt of amlodipine, a long‑acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4‑(2‑chlorophenyl)‑1,4‑dihydro‑6‑methyl‑3,5‑pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-355-77</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (58151-355-77) </PackageDescription>
    <NDC11Code>58151-0355-77</NDC11Code>
    <ProductNDC>58151-355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norvasc</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240209</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019787</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NORVASC is 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)oNORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)oChronic Stable Angina oVasospastic Angina (Prinzmetal’s or Variant Angina)oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>NORVASC is the besylate salt of amlodipine, a long‑acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4‑(2‑chlorophenyl)‑1,4‑dihydro‑6‑methyl‑3,5‑pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-402-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (58151-402-77) </PackageDescription>
    <NDC11Code>58151-0402-77</NDC11Code>
    <ProductNDC>58151-402</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Revatio</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260622</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021845</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults. REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years Old). REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. REVATIO (sildenafil) Tablets: REVATIO is formulated as white to off-white, film-coated, round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. REVATIO (sildenafil) Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution in a single-dose vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate (equivalent to 0.8 mg sildenafil), 50.5 mg dextrose, and water for injection. REVATIO (sildenafil) for Oral Suspension: REVATIO is supplied as white to slight pink powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include citric acid anhydrous, colloidal silicon dioxide anhydrous, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 1 mL and 2 mL dose markings) are provided.</Description>
  </NDC>
  <NDC>
    <NDCCode>10345-103-02</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE (10345-103-02) </PackageDescription>
    <NDC11Code>10345-0103-02</NDC11Code>
    <ProductNDC>10345-103</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>L Occitane En Provence Lavender Scent Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201223</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>LABORATOIRES M&amp;L</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.77</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-236-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-236-01) </PackageDescription>
    <NDC11Code>31722-0236-01</NDC11Code>
    <ProductNDC>31722-236</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215523</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</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>2021-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d­-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white 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 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&amp;C blue No. 1, FD&amp;C red No. 3, FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 4 20 mg: FD&amp;C red No. 40, FD&amp;C blue No. 1 and D&amp;C yellow No. 10, 5 25 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>42961-094-01</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE, PLASTIC (42961-094-01)</PackageDescription>
    <NDC11Code>42961-0094-01</NDC11Code>
    <ProductNDC>42961-094</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fad First Aid Direct Buffered Eye And Skin</ProprietaryName>
    <NonProprietaryName>Purified Water</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL</RouteName>
    <StartMarketingDate>20140715</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Cintas Corporation</LabelerName>
    <SubstanceName>WATER</SubstanceName>
    <StrengthNumber>985.77</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For flushing the eye to remove loose foreign material or air pollutants (smog or pollen).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43219-018-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (43219-018-30)  &gt; 88 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>43219-0018-30</NDC11Code>
    <ProductNDC>43219-018</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visage Envy Facial Moisturizing Spf30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180505</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Emilia Cosmetics Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>1.86; 3.55; 3.55; 1.77</StrengthNumber>
    <StrengthUnit>g/236.59mL; g/236.59mL; g/236.59mL; g/236.59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66758-236-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-01) </PackageDescription>
    <NDC11Code>66758-0236-01</NDC11Code>
    <ProductNDC>66758-236</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Focalin</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050531</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021802</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</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>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white 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 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&amp;C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&amp;C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>66758-236-31</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-31) </PackageDescription>
    <NDC11Code>66758-0236-31</NDC11Code>
    <ProductNDC>66758-236</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Focalin</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050531</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021802</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</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>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white 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 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&amp;C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&amp;C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&amp;C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-060-93</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58151-060-93) </PackageDescription>
    <NDC11Code>58151-0060-93</NDC11Code>
    <ProductNDC>58151-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Caduet</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021540</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
    <Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-061-93</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58151-061-93) </PackageDescription>
    <NDC11Code>58151-0061-93</NDC11Code>
    <ProductNDC>58151-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Caduet</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260928</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021540</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
    <Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>58151-062-93</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58151-062-93) </PackageDescription>
    <NDC11Code>58151-0062-93</NDC11Code>
    <ProductNDC>58151-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Caduet</ProprietaryName>
    <NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260225</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021540</ApplicationNumber>
    <LabelerName>Viatris Specialty LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
    <Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
  </NDC>
</NDCList>