entresto

Generic: sacubitril and valsartan

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name entresto
Generic Name sacubitril and valsartan
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0659
Product ID 0078-0659_a0cb416b-6ead-4623-949b-ee3d9dd1143a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207620
Listing Expiration 2026-12-31
Marketing Start 2015-07-07

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780659
Hyphenated Format 0078-0659

Supplemental Identifiers

RxCUI
1656340 1656346 1656349 1656351 1656354 1656356 2679793 2679797 2679800 2679802
UNII
80M03YXJ7I 17ERJ0MKGI
NUI
N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name entresto (source: ndc)
Generic Name sacubitril and valsartan (source: ndc)
Application Number NDA207620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 mg/1
  • 26 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20)
  • 180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67)
source: ndc

Packages (2)

0078-0659-20 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20) 0078-0659-67 180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67)

Ingredients (2)

sacubitril (24 mg/1) valsartan (26 mg/1)

Linked Drug Pages (1)

ENTRESTO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0cb416b-6ead-4623-949b-ee3d9dd1143a", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802"], "spl_set_id": ["000dc81d-ab91-450c-8eae-8eb74e72296f"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20)", "package_ndc": "0078-0659-20", "marketing_start_date": "20150707"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67)", "package_ndc": "0078-0659-67", "marketing_start_date": "20150707"}], "brand_name": "ENTRESTO", "product_id": "0078-0659_a0cb416b-6ead-4623-949b-ee3d9dd1143a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "0078-0659", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTRESTO", "active_ingredients": [{"name": "SACUBITRIL", "strength": "24 mg/1"}, {"name": "VALSARTAN", "strength": "26 mg/1"}], "application_number": "NDA207620", "marketing_category": "NDA", "marketing_start_date": "20150707", "listing_expiration_date": "20261231"}