NDC 0078-0696

ENTRESTO

Sacubitril And Valsartan

ENTRESTO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Sacubitril; Valsartan.

Product ID0078-0696_4ab35376-38ac-4b17-9c18-78bdbe23992a
NDC0078-0696
Product TypeHuman Prescription Drug
Proprietary NameENTRESTO
Generic NameSacubitril And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-07-07
Marketing CategoryNDA / NDA
Application NumberNDA207620
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameSACUBITRIL; VALSARTAN
Active Ingredient Strength97 mg/1; mg/1
Pharm ClassesNeprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0696-20

60 TABLET, FILM COATED in 1 BOTTLE (0078-0696-20)
Marketing Start Date2015-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0696-20 [00078069620]

ENTRESTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-07

NDC 0078-0696-35 [00078069635]

ENTRESTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-07
Marketing End Date2020-06-30

NDC 0078-0696-67 [00078069667]

ENTRESTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-07

NDC 0078-0696-61 [00078069661]

ENTRESTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-07

Drug Details

Active Ingredients

IngredientStrength
SACUBITRIL97 mg/1

OpenFDA Data

SPL SET ID:000dc81d-ab91-450c-8eae-8eb74e72296f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656349
  • 1656340
  • 1656351
  • 1656356
  • 1656346
  • 1656354
  • Pharmacological Class

    • Neprilysin Inhibitor [EPC]
    • Neprilysin Inhibitors [MoA]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    NDC Crossover Matching brand name "ENTRESTO" or generic name "Sacubitril And Valsartan"

    NDCBrand NameGeneric Name
    0078-0659ENTRESTOSacubitril and Valsartan
    0078-0696ENTRESTOSacubitril and Valsartan
    0078-0777ENTRESTOSacubitril and Valsartan
    0078-9659ENTRESTOSacubitril and Valsartan
    0078-9777ENTRESTOSacubitril and Valsartan

    Trademark Results [ENTRESTO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENTRESTO
    ENTRESTO
    86607963 4929041 Live/Registered
    Novartis AG
    2015-04-23
    ENTRESTO
    ENTRESTO
    85471483 not registered Dead/Abandoned
    Novartis AG
    2011-11-14

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