NDC 0078-0659

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 ID: 0078-0659_4ab35376-38ac-4b17-9c18-78bdbe23992a
• NDC: 0078-0659
• Product Type: Human Prescription Drug
• Proprietary Name: ENTRESTO
• Generic Name: Sacubitril And Valsartan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-07
• Marketing Category: NDA / NDA
• Application Number: NDA207620
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: SACUBITRIL; VALSARTAN
• Active Ingredient Strength: 24 mg/1; mg/1
• Pharm Classes: Neprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0659-20

60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20)

• Marketing Start Date: 2015-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0659-61 [00078065961]

ENTRESTO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207620
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-07

NDC 0078-0659-20 [00078065920]

ENTRESTO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207620
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-07

NDC 0078-0659-67 [00078065967]

ENTRESTO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207620
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-07

NDC 0078-0659-35 [00078065935]

ENTRESTO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207620
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-07
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
SACUBITRIL	24 mg/1

OpenFDA Data

• SPL SET ID: 000dc81d-ab91-450c-8eae-8eb74e72296f
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 17ERJ0MKGI
  • 80M03YXJ7I
• 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"

NDC	Brand Name	Generic Name
0078-0659	ENTRESTO	Sacubitril and Valsartan
0078-0696	ENTRESTO	Sacubitril and Valsartan
0078-0777	ENTRESTO	Sacubitril and Valsartan
0078-9659	ENTRESTO	Sacubitril and Valsartan
0078-9777	ENTRESTO	Sacubitril and Valsartan