RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>83542-409-00</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (83542-409-00)  / 30 mL in 1 TUBE</PackageDescription>
    <NDC11Code>83542-0409-00</NDC11Code>
    <ProductNDC>83542-409</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jess Beauty Sun Drops Sunscreen Oil Spf-50</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>JESS BEAUTY PRODUCTS LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 50; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83542-410-00</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (83542-410-00)  / 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>83542-0410-00</NDC11Code>
    <ProductNDC>83542-410</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jess Beauty Let It Sun Sunscreen Spf-50</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>JESS BEAUTY PRODUCTS LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 50; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83542-429-00</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (83542-429-00)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>83542-0429-00</NDC11Code>
    <ProductNDC>83542-429</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jess Beauty Sun Drops Protection Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>OIL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>JESS BEAUTY PRODUCTS LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 100; 50; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12578-409-00</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (12578-409-00) </PackageDescription>
    <NDC11Code>12578-0409-00</NDC11Code>
    <ProductNDC>12578-409</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20000327</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Janssen Pharmaceutica NV</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-12-14</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>27-MAR-00</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>50419-409-00</NDCCode>
    <PackageDescription>90 BLISTER PACK in 1 PACKAGE (50419-409-00)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50419-0409-00</NDC11Code>
    <ProductNDC>50419-409</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Natazia</ProprietaryName>
    <NonProprietaryName>Estradiol Valerate And Estradiol Valerate/dienogest</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20100506</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022252</ApplicationNumber>
    <LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-07-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1) . The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of &gt;30 kg/m2 has not been evaluated. (1, 8.8). Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. (1.2).</IndicationAndUsage>
    <Description>Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets: 1 2 dark yellow tablets each containing 3 mg estradiol valerate , 2 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest , 3 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest , 4 2 dark red tablets each containing 1 mg estradiol valerate , 5 2 white tablets (inert).</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-409-13</NDCCode>
    <PackageDescription>5 VIAL in 1 CARTON (67457-409-13)  / 1 mL in 1 VIAL (67457-409-00) </PackageDescription>
    <NDC11Code>67457-0409-13</NDC11Code>
    <ProductNDC>67457-409</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20140301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075440</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate injection is the decanoate ester of haloperidol, for intramuscular use. Haloperidol is a typical antipsychotic. The structural formula of haloperidol decanoate is 4-(4-Chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate. Haloperidol decanoate, USP is a white or almost white powder. The molecular formula is C31H41CIFNO3 and has a molecular weight of 530.11. Haloperidol decanoate is very soluble in alcohol, in methanol and in methylene chloride, practically insoluble in water. Each mL of haloperidol decanoate injection contains: 1 50 mg of haloperidol (present as 70.52 mg of haloperidol decanoate, USP) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative., 2 100 mg of haloperidol (present as 141.04 mg of haloperidol decanoate, USP) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>70956-409-00</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (70956-409-00)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70956-0409-00</NDC11Code>
    <ProductNDC>70956-409</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jafra Long Wear Makeup Broad Spectrum Spf 20 Natural M2</ProprietaryName>
    <NonProprietaryName>Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Absara Cosmetics S.A.P.I DE C.V.</LabelerName>
    <SubstanceName>OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>30; 68.2</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50090-3087-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-3087-0) </PackageDescription>
    <NDC11Code>50090-3087-00</NDC11Code>
    <ProductNDC>50090-3087</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208803</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)- 3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets, USP are available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-3422-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-3422-0) </PackageDescription>
    <NDC11Code>50090-3422-00</NDC11Code>
    <ProductNDC>50090-3422</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209838</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)­-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: Ezetimibe USP is a white crystalline powder that is freely to very soluble in ethanol, methanol, acetonitrile and acetone and practically insoluble in water. It is also insoluble in non-polar solvents such as hexane. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets USP is available as a tablet for oral use containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-3657-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (50090-3657-0) </PackageDescription>
    <NDC11Code>50090-3657-00</NDC11Code>
    <ProductNDC>50090-3657</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209234</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is.  Ezetimibe, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-3984-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-3984-0) </PackageDescription>
    <NDC11Code>50090-3984-00</NDC11Code>
    <ProductNDC>50090-3984</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-4772-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-4772-0) </PackageDescription>
    <NDC11Code>50090-4772-00</NDC11Code>
    <ProductNDC>50090-4772</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209222</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin. Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated.  As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C). o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with.                heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contains ezetimibe, USP, a dietary cholesterol absorption inhibitor, and simvastatin, USP, an HMG-CoA reductase inhibitor.  The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.43.  Ezetimibe, USP is a white to off white, crystalline powder, hygroscopic that is soluble in methanol. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2, 2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white powder that is freely soluble in chloroform, methanol and alcohol. Sparingly soluble in Propylene glycol, very slightly soluble in Hexane. Practically insoluble in water. Its structural formula is:. Ezetimibe and simvastatin tablets is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/80). Each tablet contains the following inactive ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Sodium Lauryl Sulfate, Hypromellose, Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5169-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-5169-0) </PackageDescription>
    <NDC11Code>50090-5169-00</NDC11Code>
    <ProductNDC>50090-5169</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prasugrel</ProprietaryName>
    <NonProprietaryName>Prasugrel</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205987</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>PRASUGREL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prasugrel is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: : 1 Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) ( 1.1). , 2 Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (  1.1).  .</IndicationAndUsage>
    <Description>Prasugrel tablets contain prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the empirical formula C 20H 20FNO 3SHCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is:. Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Prasugrel tablets are available for oral administration as 5-mg or 10-mg elongated hexagonal, film-coated, non-scored tablets, debossed on each side. Each yellow 5-mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5-mg prasugrel and each beige 10-mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10-mg of prasugrel.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-6630-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-6630-0) </PackageDescription>
    <NDC11Code>50090-6630-00</NDC11Code>
    <ProductNDC>50090-6630</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209838</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)­-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: Ezetimibe USP is a white crystalline powder that is freely to very soluble in ethanol, methanol, acetonitrile and acetone and practically insoluble in water. It is also insoluble in non-polar solvents such as hexane. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets USP is available as a tablet for oral use containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-6631-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-6631-0) </PackageDescription>
    <NDC11Code>50090-6631-00</NDC11Code>
    <ProductNDC>50090-6631</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209838</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)­-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: Ezetimibe USP is a white crystalline powder that is freely to very soluble in ethanol, methanol, acetonitrile and acetone and practically insoluble in water. It is also insoluble in non-polar solvents such as hexane. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets USP is available as a tablet for oral use containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7047-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-7047-0) </PackageDescription>
    <NDC11Code>50090-7047-00</NDC11Code>
    <ProductNDC>50090-7047</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208699</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>Ezetimibe and Simvastatin Tablets contain ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.44 g/mol. Ezetimibe is a white, crystalline powder that is freely soluble in ethanol, methanol and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7α,8α(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin is a white to off-white, nonhygroscopic powder that is freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol, very slightly soluble in hexane and practically insoluble in water. Its structural formula is. Ezetimibe and Simvastatin Tablets are available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/10 mg), 20 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/20 mg), 40 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/40 mg), or 80 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7099-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-7099-0) </PackageDescription>
    <NDC11Code>50090-7099-00</NDC11Code>
    <ProductNDC>50090-7099</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209838</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)­-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: Ezetimibe USP is a white crystalline powder that is freely to very soluble in ethanol, methanol, acetonitrile and acetone and practically insoluble in water. It is also insoluble in non-polar solvents such as hexane. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets USP is available as a tablet for oral use containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7236-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-7236-0) </PackageDescription>
    <NDC11Code>50090-7236-00</NDC11Code>
    <ProductNDC>50090-7236</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209234</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe Tablets is indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is.  Ezetimibe, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7338-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-7338-0) </PackageDescription>
    <NDC11Code>50090-7338-00</NDC11Code>
    <ProductNDC>50090-7338</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078560</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid‑lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1‑(4‑fluorophenyl)‑3(R)‑[3‑(4‑fluorophenyl)‑3(S)‑ hydroxypropyl]‑4(S)‑(4‑hydroxyphenyl)‑2‑azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white crystalline powder that is freely soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablets, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and sodium starch glycolate. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7339-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-7339-0) </PackageDescription>
    <NDC11Code>50090-7339-00</NDC11Code>
    <ProductNDC>50090-7339</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078560</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid‑lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1‑(4‑fluorophenyl)‑3(R)‑[3‑(4‑fluorophenyl)‑3(S)‑ hydroxypropyl]‑4(S)‑(4‑hydroxyphenyl)‑2‑azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white crystalline powder that is freely soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablets, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and sodium starch glycolate. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7689-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (50090-7689-0) </PackageDescription>
    <NDC11Code>50090-7689-00</NDC11Code>
    <ProductNDC>50090-7689</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220726</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210859</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated:  In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).  In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.  In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.  In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is (3R, 4S)-1-(ρ-Fluorophenyl)-3-[(3 S)-3-(ρ-fluorophenyl)-3-hydroxypropyl]-4-(ρ-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3. Its relative molecular mass is 409.43 and its structural formula is:. Ezetimibe USP is a white to off-white, crystalline powder, hygroscopic that is soluble in absolute alcohol (99.5%), acetonitrile and practically insoluble in water and in hexane. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7690-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50090-7690-0) </PackageDescription>
    <NDC11Code>50090-7690-00</NDC11Code>
    <ProductNDC>50090-7690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220726</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210859</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe tablets are indicated:  In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).  In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.  In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.  In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is (3R, 4S)-1-(ρ-Fluorophenyl)-3-[(3 S)-3-(ρ-fluorophenyl)-3-hydroxypropyl]-4-(ρ-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3. Its relative molecular mass is 409.43 and its structural formula is:. Ezetimibe USP is a white to off-white, crystalline powder, hygroscopic that is soluble in absolute alcohol (99.5%), acetonitrile and practically insoluble in water and in hexane. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-4719-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (54868-4719-0)</PackageDescription>
    <NDC11Code>54868-4719-00</NDC11Code>
    <ProductNDC>54868-4719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zetia</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021226</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021445</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy. ZETIA1, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins). ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate. ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.</IndicationAndUsage>
    <Description>ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5187-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (54868-5187-0)</PackageDescription>
    <NDC11Code>54868-5187-00</NDC11Code>
    <ProductNDC>54868-5187</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vytorin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041119</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021687</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5189-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (54868-5189-0)</PackageDescription>
    <NDC11Code>54868-5189-00</NDC11Code>
    <ProductNDC>54868-5189</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vytorin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041119</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021687</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5250-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (54868-5250-0)</PackageDescription>
    <NDC11Code>54868-5250-00</NDC11Code>
    <ProductNDC>54868-5250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vytorin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050314</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021687</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5259-0</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (54868-5259-0)</PackageDescription>
    <NDC11Code>54868-5259-00</NDC11Code>
    <ProductNDC>54868-5259</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vytorin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050404</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021687</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 80</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
    <Description>VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-6238-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-6238-0)</PackageDescription>
    <NDC11Code>54868-6238-00</NDC11Code>
    <ProductNDC>54868-6238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Effient</ProprietaryName>
    <NonProprietaryName>Prasugrel Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022307</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>PRASUGREL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: 1 Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) (1.1). , 2 Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1). .</IndicationAndUsage>
    <Description>Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Effient is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the empirical formula C20H20FNO3SHCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is. Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Effient is available for oral administration as 5 mg or 10 mg elongated hexagonal, film-coated, non-scored tablets, debossed on each side. Each yellow 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg prasugrel and each beige 10 mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel. During manufacture and storage, partial conversion from prasugrel hydrochloride to prasugrel free base may occur. Other ingredients include mannitol, hypromellose, croscarmellose sodium, microcrystalline cellulose, and vegetable magnesium stearate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10 mg tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>70518-1955-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-1955-0) </PackageDescription>
    <NDC11Code>70518-1955-00</NDC11Code>
    <ProductNDC>70518-1955</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209222</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin. Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated.  As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C). o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with.                heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contains ezetimibe, USP, a dietary cholesterol absorption inhibitor, and simvastatin, USP, an HMG-CoA reductase inhibitor.  The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3and its molecular weight is 409.43.  Ezetimibe, USP is a white to off white, crystalline powder, hygroscopic that is soluble in methanol. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2, 2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin, USP is C 25H 38O 5and its molecular weight is 418.57. Simvastatin, USP is a white to off-white powder that is freely soluble in chloroform, methanol and alcohol. Sparingly soluble in Propylene glycol, very slightly soluble in Hexane. Practically insoluble in water. Its structural formula is:. Ezetimibe and simvastatin tablets is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/80). Each tablet contains the following inactive ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Sodium Lauryl Sulfate, Hypromellose, Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70518-3334-0</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-3334-0) </PackageDescription>
    <NDC11Code>70518-3334-00</NDC11Code>
    <ProductNDC>70518-3334</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe</ProprietaryName>
    <NonProprietaryName>Ezetimibe</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203931</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>EZETIMIBE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe is indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)., 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH., 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia., 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)., 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.</IndicationAndUsage>
    <Description>Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3. Its molecular weight is 409.4 and its structural formula is:. Ezetimibe, USP is a white to off-white crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.</Description>
  </NDC>
</NDCList>