sacubitril and valsartan (31722-674)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler camber pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer

Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-674

Product ID 31722-674_3a93c356-cfa8-4c31-e063-6394a90a536a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213668

Listing Expiration 2026-12-31

Marketing Start 2025-07-23

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 31722674

Hyphenated Format 31722-674

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0331722673600 0331722675604 0331722674607

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 ANDA213668 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

49 mg/1
51 mg/1

source: ndc

Packaging

180 TABLET, FILM COATED in 1 BOTTLE (31722-674-18)
60 TABLET, FILM COATED in 1 BOTTLE (31722-674-60)

source: ndc

Packages (2)

31722-674-18 180 TABLET, FILM COATED in 1 BOTTLE (31722-674-18) 31722-674-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-674-60)

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": "3a93c356-cfa8-4c31-e063-6394a90a536a", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0331722673600", "0331722675604", "0331722674607"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["65a3e298-279d-4498-a7be-5f9ee5bc77d8"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (31722-674-18)", "package_ndc": "31722-674-18", "marketing_start_date": "20250723"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-674-60)", "package_ndc": "31722-674-60", "marketing_start_date": "20250723"}], "brand_name": "Sacubitril and valsartan", "product_id": "31722-674_3a93c356-cfa8-4c31-e063-6394a90a536a", "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": "31722-674", "generic_name": "Sacubitril and valsartan", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "ANDA213668", "marketing_category": "ANDA", "marketing_start_date": "20250723", "listing_expiration_date": "20261231"}