sacubitril and valsartan (69238-2733)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler amneal pharmaceuticals ny llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2733

Product ID 69238-2733_fc1d1a2c-611d-4238-b421-49f3887e880c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213605

Listing Expiration 2026-12-31

Marketing Start 2025-06-02

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 692382733

Hyphenated Format 69238-2733

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0369238273113 0369238273212 0369238273311

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 ANDA213605 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

97 mg/1
103 mg/1

source: ndc

Packaging

60 TABLET, FILM COATED in 1 BOTTLE (69238-2733-1)
180 TABLET, FILM COATED in 1 BOTTLE (69238-2733-2)

source: ndc

Packages (2)

69238-2733-1 60 TABLET, FILM COATED in 1 BOTTLE (69238-2733-1) 69238-2733-2 180 TABLET, FILM COATED in 1 BOTTLE (69238-2733-2)

Ingredients (2)

sacubitril (97 mg/1) valsartan (103 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": "fc1d1a2c-611d-4238-b421-49f3887e880c", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0369238273113", "0369238273212", "0369238273311"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["e4011f11-2035-4f32-8df6-b1580c2a6e2a"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (69238-2733-1)", "package_ndc": "69238-2733-1", "marketing_start_date": "20250602"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (69238-2733-2)", "package_ndc": "69238-2733-2", "marketing_start_date": "20250602"}], "brand_name": "Sacubitril and Valsartan", "product_id": "69238-2733_fc1d1a2c-611d-4238-b421-49f3887e880c", "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": "69238-2733", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "97 mg/1"}, {"name": "VALSARTAN", "strength": "103 mg/1"}], "application_number": "ANDA213605", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}