sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-607
Product ID 50268-607_41157d4f-c26f-4c55-e063-6394a90a5b9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213748
Listing Expiration 2026-12-31
Marketing Start 2025-10-13

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 50268607
Hyphenated Format 50268-607

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UNII
80M03YXJ7I 17ERJ0MKGI
NUI
N0000000070 N0000175561

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 sacubitril and valsartan (source: ndc)
Generic Name sacubitril and valsartan (source: ndc)
Application Number ANDA213748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 49 mg/1
  • 51 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-607-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-607-11)
source: ndc

Packages (1)

50268-607-15 50 BLISTER PACK in 1 BOX (50268-607-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-607-11)

Ingredients (2)

sacubitril (49 mg/1) valsartan (51 mg/1)

Linked Drug Pages (1)

Sacubitril and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41157d4f-c26f-4c55-e063-6394a90a5b9b", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["4114a976-2e58-8437-e063-6394a90af298"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-607-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-607-11)", "package_ndc": "50268-607-15", "marketing_start_date": "20251013"}], "brand_name": "Sacubitril and Valsartan", "product_id": "50268-607_41157d4f-c26f-4c55-e063-6394a90a5b9b", "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": "50268-607", "generic_name": "Sacubitril and Valsartan", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "49 mg/1"}, {"name": "VALSARTAN", "strength": "51 mg/1"}], "application_number": "ANDA213748", "marketing_category": "ANDA", "marketing_start_date": "20251013", "listing_expiration_date": "20261231"}