sacubitril and valsartan (0904-7580)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler major pharmaceuticals

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer

Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7580

Product ID 0904-7580_f2cba3db-0256-422a-a8a4-7afb3a9970d0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213764

Listing Expiration 2026-12-31

Marketing Start 2025-11-03

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 09047580

Hyphenated Format 0904-7580

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

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 sacubitril and valsartan (source: ndc)

Generic Name sacubitril and valsartan (source: ndc)

Application Number ANDA213764 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

24 mg/1
26 mg/1

source: ndc

Packaging

30 BLISTER PACK in 1 CARTON (0904-7580-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (1)

0904-7580-04 30 BLISTER PACK in 1 CARTON (0904-7580-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

sacubitril (24 mg/1) valsartan (26 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": "f2cba3db-0256-422a-a8a4-7afb3a9970d0", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["f2cba3db-0256-422a-a8a4-7afb3a9970d0"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7580-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7580-04", "marketing_start_date": "20251103"}], "brand_name": "Sacubitril and Valsartan", "product_id": "0904-7580_f2cba3db-0256-422a-a8a4-7afb3a9970d0", "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": "0904-7580", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "24 mg/1"}, {"name": "VALSARTAN", "strength": "26 mg/1"}], "application_number": "ANDA213764", "marketing_category": "ANDA", "marketing_start_date": "20251103", "listing_expiration_date": "20261231"}