RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>0078-0639-97</NDCCode>
    <PackageDescription>1 mL in 1 CARTON (0078-0639-97) </PackageDescription>
    <NDC11Code>00078-0639-97</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0639-41</NDCCode>
    <PackageDescription>2 mL in 1 CARTON (0078-0639-41) </PackageDescription>
    <NDC11Code>00078-0639-41</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0639-68</NDCCode>
    <PackageDescription>1 mL in 1 CARTON (0078-0639-68) </PackageDescription>
    <NDC11Code>00078-0639-68</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0639-98</NDCCode>
    <PackageDescription>2 mL in 1 CARTON (0078-0639-98) </PackageDescription>
    <NDC11Code>00078-0639-98</NDC11Code>
    <ProductNDC>0078-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0429-97</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0078-0429-97)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00078-0429-97</NDC11Code>
    <ProductNDC>0078-0429</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Genteal</ProprietaryName>
    <ProprietaryNameSuffix>Severe</ProprietaryNameSuffix>
    <NonProprietaryName>Hypromellose</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20090914</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>HYPROMELLOSE 2910 (4000 MPA.S)</SubstanceName>
    <StrengthNumber>.003</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0473-97</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0078-0473-97)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>00078-0473-97</NDC11Code>
    <ProductNDC>0078-0473</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Genteal</ProprietaryName>
    <ProprietaryNameSuffix>Night-time Pm</ProprietaryNameSuffix>
    <NonProprietaryName>White Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <EndMarketingDate>20220430</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Novartis Pharmaceutical Corporation</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM</SubstanceName>
    <StrengthNumber>.15; .85</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20091214</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1056-97</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0078-1056-97)  / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>00078-1056-97</NDC11Code>
    <ProductNDC>0078-1056</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cosentyx</ProprietaryName>
    <NonProprietaryName>Secukinumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150121</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125504</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SECUKINUMAB</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
    <Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-078-97</NDCCode>
    <PackageDescription>126 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-078-97)</PackageDescription>
    <NDC11Code>33261-0078-97</NDC11Code>
    <ProductNDC>33261-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nabumetone</ProprietaryName>
    <NonProprietaryName>Nabumetone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078671</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NABUMETONE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
    <Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl methyl cellulose, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The 500 mg tablets also contain opadry white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol and Polysorbate 80) and the 750 mg tablets contain opadry beige (Hypromellose 6cP, titanium dioxide, iron oxide yellow, iron oxide red and Macrogol).</Description>
  </NDC>
  <NDC>
    <NDCCode>62207-078-97</NDCCode>
    <PackageDescription>40000 TABLET in 1 DRUM (62207-078-97) </PackageDescription>
    <NDC11Code>62207-0078-97</NDC11Code>
    <ProductNDC>62207-078</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20250102</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JAN-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>69097-078-97</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (69097-078-97)  / 5 mL in 1 VIAL (69097-078-67) </PackageDescription>
    <NDC11Code>69097-0078-97</NDC11Code>
    <ProductNDC>69097-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Phosphates</ProprietaryName>
    <NonProprietaryName>Potassium Phosphates</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217892</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>224; 236</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
    <Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-639-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63187-639-30) </PackageDescription>
    <NDC11Code>63187-0639-30</NDC11Code>
    <ProductNDC>63187-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
    <NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204165</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLOPIDOGREL is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome, 2  - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], CLOPIDOGREL has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1).</IndicationAndUsage>
    <Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9.  The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-639-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-639-60) </PackageDescription>
    <NDC11Code>63187-0639-60</NDC11Code>
    <ProductNDC>63187-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
    <NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204165</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLOPIDOGREL is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome, 2  - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], CLOPIDOGREL has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1).</IndicationAndUsage>
    <Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9.  The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-639-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-639-90) </PackageDescription>
    <NDC11Code>63187-0639-90</NDC11Code>
    <ProductNDC>63187-639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
    <NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204165</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLOPIDOGREL is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome, 2  - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], CLOPIDOGREL has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1).</IndicationAndUsage>
    <Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9.  The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0659-20</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20) </PackageDescription>
    <NDC11Code>00078-0659-20</NDC11Code>
    <ProductNDC>0078-0659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</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>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0659-67</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67) </PackageDescription>
    <NDC11Code>00078-0659-67</NDC11Code>
    <ProductNDC>0078-0659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</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>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0696-20</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0078-0696-20) </PackageDescription>
    <NDC11Code>00078-0696-20</NDC11Code>
    <ProductNDC>0078-0696</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</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>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
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    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
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    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (0078-9659-50) </PackageDescription>
    <NDC11Code>00078-9659-50</NDC11Code>
    <ProductNDC>0078-9659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</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>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180823</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-9777-50</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (0078-9777-50) </PackageDescription>
    <NDC11Code>00078-9777-50</NDC11Code>
    <ProductNDC>0078-9777</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</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>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180823</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ENTRESTO is 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is 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 hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). 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 (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-03</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE (0054-0639-03) </PackageDescription>
    <NDC11Code>00054-0639-03</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-05</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (0054-0639-05) </PackageDescription>
    <NDC11Code>00054-0639-05</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets. Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C20H25N3O2C4H4O4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-13</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE (0054-0639-13) </PackageDescription>
    <NDC11Code>00054-0639-13</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0639-25</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0054-0639-25) </PackageDescription>
    <NDC11Code>00054-0639-25</NDC11Code>
    <ProductNDC>0054-0639</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylergonovine Maleate</ProprietaryName>
    <NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180703</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210424</ApplicationNumber>
    <LabelerName>West-Ward Pharmaceuticals Corp</LabelerName>
    <SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180703</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
    <Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.  Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C  20H  25N  3O  2C  4H  4O  4                Mol Wt:  455.51.</Description>
  </NDC>
  <NDC>
    <NDCCode>0268-0639-05</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-0639-05) </PackageDescription>
    <NDC11Code>00268-0639-05</NDC11Code>
    <ProductNDC>0268-0639</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Mus Musculus Skin</ProprietaryName>
    <NonProprietaryName>Mouse Epithelia</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>MUS MUSCULUS SKIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0363-0639-03</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0363-0639-03)  &gt; 56 g in 1 TUBE (0363-0639-01) </PackageDescription>
    <NDC11Code>00363-0639-03</NDC11Code>
    <ProductNDC>0363-0639</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Regular Strength Hydrocortisone Cream</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160607</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Walgreens</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>.51</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
  </NDC>
</NDCList>