RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>59726-751-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-751-20)  / 20 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0751-20</NDC11Code>
    <ProductNDC>59726-751</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201204</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202807</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20201204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular aches minor pain of arthritistoothachebackache the common coldmenstrual cramps. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49349-751-03</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 CARTON (49349-751-03)</PackageDescription>
    <NDC11Code>49349-0751-03</NDC11Code>
    <ProductNDC>49349-751</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyvox</ProprietaryName>
    <NonProprietaryName>Linezolid</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130403</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021130</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LINEZOLID</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>50844-751-20</NDCCode>
    <PackageDescription>225 TABLET, FILM COATED in 1 BOTTLE (50844-751-20) </PackageDescription>
    <NDC11Code>50844-0751-20</NDC11Code>
    <ProductNDC>50844-751</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Reliever</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930402</StartMarketingDate>
    <EndMarketingDate>20230522</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>L.N.K. International, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19930402</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230522</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51079-751-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-751-20)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-751-01)</PackageDescription>
    <NDC11Code>51079-0751-20</NDC11Code>
    <ProductNDC>51079-751</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091590</ApplicationNumber>
    <LabelerName>UDL Laboratories, Inc.</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-19</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55700-751-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (55700-751-20) </PackageDescription>
    <NDC11Code>55700-0751-20</NDC11Code>
    <ProductNDC>55700-751</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190510</StartMarketingDate>
    <EndMarketingDate>20211031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204755</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>875; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190510</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61919-751-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (61919-751-20) </PackageDescription>
    <NDC11Code>61919-0751-20</NDC11Code>
    <ProductNDC>61919-751</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077903</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. [Image 1]. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>59726-046-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-046-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0046-20</NDC11Code>
    <ProductNDC>59726-046</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201204</StartMarketingDate>
    <EndMarketingDate>20270201</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207753</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20201204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-174-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-174-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0174-20</NDC11Code>
    <ProductNDC>59726-174</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180401</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208363</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180401</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold. temporarily reduces fever .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-199-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-199-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0199-20</NDC11Code>
    <ProductNDC>59726-199</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210129</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078682</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210129</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-279-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-279-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0279-20</NDC11Code>
    <ProductNDC>59726-279</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206568</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-733-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (59726-733-20)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0733-20</NDC11Code>
    <ProductNDC>59726-733</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief Dm</ProprietaryName>
    <NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209692</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>600; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-734-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (59726-734-20)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0734-20</NDC11Code>
    <ProductNDC>59726-734</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Relief</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241206</StartMarketingDate>
    <EndMarketingDate>20270828</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207342</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241206</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270828</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-745-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-745-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0745-20</NDC11Code>
    <ProductNDC>59726-745</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180930</StartMarketingDate>
    <EndMarketingDate>20261228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206568</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-748-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-748-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>59726-0748-20</NDC11Code>
    <ProductNDC>59726-748</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220225</StartMarketingDate>
    <EndMarketingDate>20260410</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208363</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220225</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260410</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59726-773-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (59726-773-20)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0773-20</NDC11Code>
    <ProductNDC>59726-773</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <ProprietaryNameSuffix>Ultra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Simethicone</NonProprietaryName>
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    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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    <SubstanceName>DIMETHICONE</SubstanceName>
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    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>59726-831-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (59726-831-20)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0831-20</NDC11Code>
    <ProductNDC>59726-831</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <StartMarketingDate>20190331</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
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    <ApplicationNumber>ANDA207342</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
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    <LastUpdate>2026-04-01</LastUpdate>
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    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  </NDC>
  <NDC>
    <NDCCode>59726-833-20</NDCCode>
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    <NDC11Code>59726-0833-20</NDC11Code>
    <ProductNDC>59726-833</ProductNDC>
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    <EndMarketingDate>20260201</EndMarketingDate>
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    <LastUpdate>2026-02-02</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <EndMarketingDatePackage>20260201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive . temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhales irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59726-897-20</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (59726-897-20)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59726-0897-20</NDC11Code>
    <ProductNDC>59726-897</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gas Relief</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Simethicone</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190731</StartMarketingDate>
    <EndMarketingDate>20270201</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M002</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270201</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0378-4513-93</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4513-93) </PackageDescription>
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    <ProductNDC>0378-4513</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200465</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
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    <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>
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    <LastUpdate>2025-03-24</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <StartMarketingDatePackage>20150402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 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). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-4514-93</NDCCode>
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    <NDC11Code>00378-4514-93</NDC11Code>
    <ProductNDC>0378-4514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140521</StartMarketingDate>
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    <ApplicationNumber>ANDA200465</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
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    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 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). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
  </NDC>
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    <NDCCode>0378-4515-93</NDCCode>
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    <StartMarketingDate>20141016</StartMarketingDate>
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    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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    <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>
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    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 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). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 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). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction &lt; 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 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). As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
    <Description>Amlodipine and atorvastatin tablets, USP 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 (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Its emperical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as Calcium (βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2), trihydrate. Its emperical formula is C66H68CaF2N4O103H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium USP, 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. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.94 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.844 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 20 mg atorvastatin equivalent to 21.688 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 40 mg atorvastatin equivalent to 43.376 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.88 mg amlodipine besylate and 80 mg atorvastatin equivalent to 86.751 mg atorvastatin calcium.</Description>
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    <Description>Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base. Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula.</Description>
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    <StartMarketingDatePackage>20220820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril hydrochloride 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.  These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.  Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (&gt;100 mg/mL) in water, in ethanol, and in methanol.  Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3 phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Each benazepril hydrochloride tablet, USP contains 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, FD&amp;C yellow #6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. In addition, the 5 mg and 10 mg contain D&amp;C yellow #10 Aluminum Lake, and the 20 mg and 40 mg contain FD&amp;C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-751-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (23155-751-05) </PackageDescription>
    <NDC11Code>23155-0751-05</NDC11Code>
    <ProductNDC>23155-751</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076267</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril hydrochloride 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.  These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.  Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (&gt;100 mg/mL) in water, in ethanol, and in methanol.  Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3 phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Each benazepril hydrochloride tablet, USP contains 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, FD&amp;C yellow #6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. In addition, the 5 mg and 10 mg contain D&amp;C yellow #10 Aluminum Lake, and the 20 mg and 40 mg contain FD&amp;C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
</NDCList>