RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>69539-050-82</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69539-050-82) </PackageDescription>
    <NDC11Code>69539-0050-82</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
    <Description>Solifenacin succinate tablets (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate(1:1) having an molecular formula of C23H26N2O2 C4H6O4 and  a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is soluble in water and in methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-051-82</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69539-051-82) </PackageDescription>
    <NDC11Code>69539-0051-82</NDC11Code>
    <ProductNDC>69539-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
    <Description>Solifenacin succinate tablets (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate(1:1) having an molecular formula of C23H26N2O2 C4H6O4 and  a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is soluble in water and in methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-050-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (69539-050-30) </PackageDescription>
    <NDC11Code>69539-0050-30</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69539-050-81</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (69539-050-81) </PackageDescription>
    <NDC11Code>69539-0050-81</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
    <Description>Solifenacin succinate tablets (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate(1:1) having an molecular formula of C23H26N2O2 C4H6O4 and  a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is soluble in water and in methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-050-83</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69539-050-83) </PackageDescription>
    <NDC11Code>69539-0050-83</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
    <Description>Solifenacin succinate tablets (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate(1:1) having an molecular formula of C23H26N2O2 C4H6O4 and  a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is soluble in water and in methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet).</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-050-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (69539-050-90) </PackageDescription>
    <NDC11Code>69539-0050-90</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69539-050-99</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69539-050-99) </PackageDescription>
    <NDC11Code>69539-0050-99</NDC11Code>
    <ProductNDC>69539-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solifenacin Succinate</ProprietaryName>
    <NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210688</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-050-82</NDCCode>
    <PackageDescription>200 TABLET, FILM COATED in 1 BOTTLE (11673-050-82) </PackageDescription>
    <NDC11Code>11673-0050-82</NDC11Code>
    <ProductNDC>11673-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Ibuprofen Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate And Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079113</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>38; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41520-050-82</NDCCode>
    <PackageDescription>200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82) </PackageDescription>
    <NDC11Code>41520-0050-82</NDC11Code>
    <ProductNDC>41520-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Care One Ibuprofen Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate And Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079113</ApplicationNumber>
    <LabelerName>American Sales Company</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>38; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50865-050-82</NDCCode>
    <PackageDescription>800 mL in 1 BOTTLE, PLASTIC (50865-050-82) </PackageDescription>
    <NDC11Code>50865-0050-82</NDC11Code>
    <ProductNDC>50865-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Soft And Silky/health Guard Antibacterial Hand</ProprietaryName>
    <NonProprietaryName>Antibacterial Hand Soap</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130920</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Kutol Products Company, Inc.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>11.7</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52915-050-29</NDCCode>
    <PackageDescription>82 g in 1 TUBE (52915-050-29) </PackageDescription>
    <NDC11Code>52915-0050-29</NDC11Code>
    <ProductNDC>52915-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Spf30 Super Sensitive Sunscreen</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ORGANIC &amp; SUSTAINABLE BEAUTY</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59779-050-82</NDCCode>
    <PackageDescription>200 TABLET, FILM COATED in 1 BOTTLE (59779-050-82) </PackageDescription>
    <NDC11Code>59779-0050-82</NDC11Code>
    <ProductNDC>59779-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate And Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079113</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>38; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68391-050-82</NDCCode>
    <PackageDescription>200 TABLET, COATED in 1 BOTTLE (68391-050-82) </PackageDescription>
    <NDC11Code>68391-0050-82</NDC11Code>
    <ProductNDC>68391-050</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Berkley And Jensen Ibuprofen Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079113</ApplicationNumber>
    <LabelerName>BJWC</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>38; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69539-093-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69539-093-05) </PackageDescription>
    <NDC11Code>69539-0093-05</NDC11Code>
    <ProductNDC>69539-093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-093-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69539-093-30) </PackageDescription>
    <NDC11Code>69539-0093-30</NDC11Code>
    <ProductNDC>69539-093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
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    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-093-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (69539-093-90) </PackageDescription>
    <NDC11Code>69539-0093-90</NDC11Code>
    <ProductNDC>69539-093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-093-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69539-093-99) </PackageDescription>
    <NDC11Code>69539-0093-99</NDC11Code>
    <ProductNDC>69539-093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-094-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69539-094-05) </PackageDescription>
    <NDC11Code>69539-0094-05</NDC11Code>
    <ProductNDC>69539-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-094-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69539-094-30) </PackageDescription>
    <NDC11Code>69539-0094-30</NDC11Code>
    <ProductNDC>69539-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-094-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (69539-094-90) </PackageDescription>
    <NDC11Code>69539-0094-90</NDC11Code>
    <ProductNDC>69539-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
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    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-094-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69539-094-99) </PackageDescription>
    <NDC11Code>69539-0094-99</NDC11Code>
    <ProductNDC>69539-094</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-095-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69539-095-05) </PackageDescription>
    <NDC11Code>69539-0095-05</NDC11Code>
    <ProductNDC>69539-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-095-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69539-095-30) </PackageDescription>
    <NDC11Code>69539-0095-30</NDC11Code>
    <ProductNDC>69539-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-095-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (69539-095-90) </PackageDescription>
    <NDC11Code>69539-0095-90</NDC11Code>
    <ProductNDC>69539-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-095-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69539-095-99) </PackageDescription>
    <NDC11Code>69539-0095-99</NDC11Code>
    <ProductNDC>69539-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-096-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69539-096-05) </PackageDescription>
    <NDC11Code>69539-0096-05</NDC11Code>
    <ProductNDC>69539-096</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-096-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69539-096-30) </PackageDescription>
    <NDC11Code>69539-0096-30</NDC11Code>
    <ProductNDC>69539-096</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-096-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (69539-096-90) </PackageDescription>
    <NDC11Code>69539-0096-90</NDC11Code>
    <ProductNDC>69539-096</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-096-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69539-096-99) </PackageDescription>
    <NDC11Code>69539-0096-99</NDC11Code>
    <ProductNDC>69539-096</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211933</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated:   To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD    o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD    o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD   As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:    o Adults with primary hyperlipidemia.    o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:    o Primary dysbetalipoproteinemia    o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is (βR, δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4(phenylcarbamoyl)pyrrole-l-heptanaote (1:2), trihydrate. The molecular formula of atorvastatin calcium USP is C66H68CaF2N4O10.3H2O and its molecular weight is 1209.41. Its structural formula is.      Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.73 mg atorvastatin calcium anhydrous) and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, magnesium aluminometasilicate, microcrystalline cellulose, polysorbate 80, precipitated calcium carbonate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol and lecithin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69539-127-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69539-127-30) </PackageDescription>
    <NDC11Code>69539-0127-30</NDC11Code>
    <ProductNDC>69539-127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213226</ApplicationNumber>
    <LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>82.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin extended-release tablets are indicated for the management of: : 1  Neuropathic pain associated with diabetic peripheral neuropathy, 2 Postherpetic neuralgia.</IndicationAndUsage>
    <Description>Pregabalin extended-release tablets are for oral use and contain pregabalin. Pregabalin USP is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin USP is:. Pregabalin USP is a white to off-white, crystalline solid with a pKa of 4.2 – 10.6. It is sparingly soluble in water and feely soluble in both basic and acidic aqueous solution. Pregabalin extended-release tablets are administered orally and contain 82.5 mg, 165 mg, or 330 mg of pregabalin, along with carbopol, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, silicon dioxide. Film Coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red (for 82.5 mg, 165 mg and 330 mg tablets), black iron oxide, (82.5 mg tablets) iron oxide yellow (for 330 mg tablets) and colorants as inactive ingredients.</Description>
  </NDC>
</NDCList>