RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>80025-433-26</NDCCode>
    <PackageDescription>1000 L in 1 CONTAINER (80025-433-26) </PackageDescription>
    <NDC11Code>80025-0433-26</NDC11Code>
    <ProductNDC>80025-433</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Blueearth Llc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>11-AUG-20</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-DEC-21</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>80025-432-26</NDCCode>
    <PackageDescription>1000000 mL in 1 CONTAINER (80025-432-26) </PackageDescription>
    <NDC11Code>80025-0432-26</NDC11Code>
    <ProductNDC>80025-432</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blueearth Antiseptic Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Blueearth Llc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200811</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59779-433-26</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (59779-433-26)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>59779-0433-26</NDC11Code>
    <ProductNDC>59779-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tussin</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19920513</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>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>Deprecated</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19990928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80025-433-05</NDCCode>
    <PackageDescription>20 L in 1 PAIL (80025-433-05) </PackageDescription>
    <NDC11Code>80025-0433-05</NDC11Code>
    <ProductNDC>80025-433</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Blueearth Llc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>11-AUG-20</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-DEC-21</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>80025-433-53</NDCCode>
    <PackageDescription>200 L in 1 DRUM (80025-433-53) </PackageDescription>
    <NDC11Code>80025-0433-53</NDC11Code>
    <ProductNDC>80025-433</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Blueearth Llc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>11-AUG-20</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-DEC-21</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0615-8459-39</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8459-39) </PackageDescription>
    <NDC11Code>00615-8459-39</NDC11Code>
    <ProductNDC>0615-8459</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040657</ApplicationNumber>
    <LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
    <Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-433-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (46708-433-30) </PackageDescription>
    <NDC11Code>46708-0433-30</NDC11Code>
    <ProductNDC>46708-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-433-31</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (46708-433-31) </PackageDescription>
    <NDC11Code>46708-0433-31</NDC11Code>
    <ProductNDC>46708-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-433-91</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (46708-433-91) </PackageDescription>
    <NDC11Code>46708-0433-91</NDC11Code>
    <ProductNDC>46708-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-638-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) </PackageDescription>
    <NDC11Code>59651-0638-01</NDC11Code>
    <ProductNDC>59651-638</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217937</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-638-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05) </PackageDescription>
    <NDC11Code>59651-0638-05</NDC11Code>
    <ProductNDC>59651-638</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217937</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&amp;C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-646-26</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (59651-646-26)  / 225 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>59651-0646-26</NDC11Code>
    <ProductNDC>59651-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218227</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil for oral suspension (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil for oral suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, lecithin, methylparaben, powdarome mixed fruit premium (which contains gum arabic, maize maltodextrin and triacetin), sodium citrate (dihydrate), sorbitol and xanthan gum. Each 7.5 mL of mycophenolate mofetil for oral suspension USP contains 18 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-955-57</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (60687-955-57)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-955-11) </PackageDescription>
    <NDC11Code>60687-0955-57</NDC11Code>
    <ProductNDC>60687-955</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213611</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of sacubitril sodium, a neprilysin inhibitor and valsartan disodium, an angiotensin II receptor blocker. Sacubitril sodium is a white to almost white powder and freely soluble in methanol and water, and practically insoluble in acetone. The chemical name of sacubitril sodium is 4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid sodium. The molecular formula is C 24H 28NO 5·Na and its molecular weight is 433.48. Its structural formula is:. Valsartan disodium is a white to almost white powder and freely soluble in water and anhydrous ethanol, and almost insoluble in dichloromethane. The chemical name of valsartan disodium is L-Valine, N-(1-oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-, sodium salt trihydrate (1:2:3). The molecular formula is C 24H 33N 5Na 2O 6and its molecular weight is 533.54. Its structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg of sacubitril sodium and 26 mg of valsartan equivalent to 28.3 mg of valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg of sacubitril sodium and 51 mg of valsartan equivalent to 56.6 mg of valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg of sacubitril sodium and 103 mg of valsartan equivalent to 113.2 mg of valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are glycerol esters of fatty acids, polyvinyl alcohol-part hydrolysed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black, iron oxide red, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-966-57</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (60687-966-57)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-966-11) </PackageDescription>
    <NDC11Code>60687-0966-57</NDC11Code>
    <ProductNDC>60687-966</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213611</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of sacubitril sodium, a neprilysin inhibitor and valsartan disodium, an angiotensin II receptor blocker. Sacubitril sodium is a white to almost white powder and freely soluble in methanol and water, and practically insoluble in acetone. The chemical name of sacubitril sodium is 4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid sodium. The molecular formula is C 24H 28NO 5·Na and its molecular weight is 433.48. Its structural formula is:. Valsartan disodium is a white to almost white powder and freely soluble in water and anhydrous ethanol, and almost insoluble in dichloromethane. The chemical name of valsartan disodium is L-Valine, N-(1-oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-, sodium salt trihydrate (1:2:3). The molecular formula is C 24H 33N 5Na 2O 6and its molecular weight is 533.54. Its structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg of sacubitril sodium and 26 mg of valsartan equivalent to 28.3 mg of valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg of sacubitril sodium and 51 mg of valsartan equivalent to 56.6 mg of valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg of sacubitril sodium and 103 mg of valsartan equivalent to 113.2 mg of valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are glycerol esters of fatty acids, polyvinyl alcohol-part hydrolysed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black, iron oxide red, and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-977-57</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (60687-977-57)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-977-11) </PackageDescription>
    <NDC11Code>60687-0977-57</NDC11Code>
    <ProductNDC>60687-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213611</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of sacubitril sodium, a neprilysin inhibitor and valsartan disodium, an angiotensin II receptor blocker. Sacubitril sodium is a white to almost white powder and freely soluble in methanol and water, and practically insoluble in acetone. The chemical name of sacubitril sodium is 4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid sodium. The molecular formula is C 24H 28NO 5·Na and its molecular weight is 433.48. Its structural formula is:. Valsartan disodium is a white to almost white powder and freely soluble in water and anhydrous ethanol, and almost insoluble in dichloromethane. The chemical name of valsartan disodium is L-Valine, N-(1-oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-, sodium salt trihydrate (1:2:3). The molecular formula is C 24H 33N 5Na 2O 6and its molecular weight is 533.54. Its structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg of sacubitril sodium and 26 mg of valsartan equivalent to 28.3 mg of valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg of sacubitril sodium and 51 mg of valsartan equivalent to 56.6 mg of valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg of sacubitril sodium and 103 mg of valsartan equivalent to 113.2 mg of valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are glycerol esters of fatty acids, polyvinyl alcohol-part hydrolysed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. The film-coat for the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black, iron oxide red, and iron oxide yellow.</Description>
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  <NDC>
    <NDCCode>61442-433-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (61442-433-01) </PackageDescription>
    <NDC11Code>61442-0433-01</NDC11Code>
    <ProductNDC>61442-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201012</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204800</ApplicationNumber>
    <LabelerName>Carlsbad Technology, Inc.</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers 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 felodipine. 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. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18H 19Cl 2NO 4 and its structural formula is:. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: lactose monohydrate, hydroxypropyl cellulose, silicon dioxide colloidal, hypromellose, magnesium stearate, calcium phosphate dibasic, butylated hydroxyanisole, polyethylene glycol, titanuium dioxide. In addition, the 5 mg and the 10 mg tablet strength contain FD&amp;C Red No. 40 powder, FD&amp;C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>61442-433-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (61442-433-05) </PackageDescription>
    <NDC11Code>61442-0433-05</NDC11Code>
    <ProductNDC>61442-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201012</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204800</ApplicationNumber>
    <LabelerName>Carlsbad Technology, Inc.</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers 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 felodipine. 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. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18H 19Cl 2NO 4 and its structural formula is:. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: lactose monohydrate, hydroxypropyl cellulose, silicon dioxide colloidal, hypromellose, magnesium stearate, calcium phosphate dibasic, butylated hydroxyanisole, polyethylene glycol, titanuium dioxide. In addition, the 5 mg and the 10 mg tablet strength contain FD&amp;C Red No. 40 powder, FD&amp;C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 3.</Description>
  </NDC>
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    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (63868-433-24)  &gt; 25 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>63868-0433-24</NDC11Code>
    <ProductNDC>63868-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Day Allergy Relief</ProprietaryName>
    <NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022429</ApplicationNumber>
    <LabelerName>CHAIN DRUG MARKETING ASSOCIATION INC.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67046-1523-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1523-3) </PackageDescription>
    <NDC11Code>67046-1523-03</NDC11Code>
    <ProductNDC>67046-1523</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250224</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040766</ApplicationNumber>
    <LabelerName>Coupler LLC</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum,Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .</IndicationAndUsage>
    <Description>Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate, USP is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, in chloroform, and in ether. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized starch, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-470-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (68382-470-01)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>68382-0470-01</NDC11Code>
    <ProductNDC>68382-470</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indomethacin</ProprietaryName>
    <NonProprietaryName>Indomethacin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206561</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>INDOMETHACIN SODIUM</SubstanceName>
    <StrengthNumber>1</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>2024-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray.</IndicationAndUsage>
    <Description>Sterile Indomethacin for injection, USP for intravenous administration is lyophilized indomethacin for injection. Each vial of indomethacin for injection contains indomethacin sodium equivalent to 1 mg indomethacin as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial. Indomethacin for injection is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl 1H-indole-3-acetic acid, sodium salt, trihydrate. Its molecular weight is 433.82. Its empirical formula is C19H15ClNNaO43H2O and its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-853-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70069-853-60) </PackageDescription>
    <NDC11Code>70069-0853-60</NDC11Code>
    <ProductNDC>70069-853</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-853-80</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (70069-853-80) </PackageDescription>
    <NDC11Code>70069-0853-80</NDC11Code>
    <ProductNDC>70069-853</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-854-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70069-854-60) </PackageDescription>
    <NDC11Code>70069-0854-60</NDC11Code>
    <ProductNDC>70069-854</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-854-80</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (70069-854-80) </PackageDescription>
    <NDC11Code>70069-0854-80</NDC11Code>
    <ProductNDC>70069-854</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-855-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70069-855-60) </PackageDescription>
    <NDC11Code>70069-0855-60</NDC11Code>
    <ProductNDC>70069-855</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-855-80</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (70069-855-80) </PackageDescription>
    <NDC11Code>70069-0855-80</NDC11Code>
    <ProductNDC>70069-855</ProductNDC>
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    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219983</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain physical mixture of sacubitril sodium and valsartan disodium. Sacubitril sodium is a neprilysin inhibitor. It is described chemically as sodium 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl) pentan-2-yl] amino]-4-oxobutanoate. The empirical formula is C24H28NNaO5 and the molecular weight is 433.47 g/mol. The structural formula is. Valsartan disodium is an angiotensin receptor blocker, chemically known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]-methyl]-(L)-valine disodium salt. The molecular formula is C24H27N5O3Na2 and the molecular weight is 479.48 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are polyvinyl alcohol-partially hydrolysed, polyethylene glycol 4000, talc, and titanium dioxide. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains ferric oxide red and ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-031-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-031-11) </PackageDescription>
    <NDC11Code>70377-0031-11</NDC11Code>
    <ProductNDC>70377-031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213680</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-031-12</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70377-031-12) </PackageDescription>
    <NDC11Code>70377-0031-12</NDC11Code>
    <ProductNDC>70377-031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213680</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-031-13</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (70377-031-13) </PackageDescription>
    <NDC11Code>70377-0031-13</NDC11Code>
    <ProductNDC>70377-031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213680</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-031-14</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70377-031-14) </PackageDescription>
    <NDC11Code>70377-0031-14</NDC11Code>
    <ProductNDC>70377-031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250717</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213680</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250717</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
  </NDC>
</NDCList>