sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-558
Product ID 62332-558_3b7867cd-b65b-47b7-a000-f31f04a564aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213682
Listing Expiration 2026-12-31
Marketing Start 2024-11-04

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 62332558
Hyphenated Format 62332-558

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UPC
0362332558605
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 ANDA213682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 97 mg/1
  • 103 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (62332-558-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 180 TABLET, FILM COATED in 1 BOTTLE (62332-558-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (62332-558-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62332-558-91)
source: ndc

Packages (4)

62332-558-10 100 BLISTER PACK in 1 CARTON (62332-558-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 62332-558-45 180 TABLET, FILM COATED in 1 BOTTLE (62332-558-45) 62332-558-60 60 TABLET, FILM COATED in 1 BOTTLE (62332-558-60) 62332-558-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-558-91)

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": "3b7867cd-b65b-47b7-a000-f31f04a564aa", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0362332558605"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["5928f174-83e5-4c74-b15a-138338a70295"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (62332-558-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "62332-558-10", "marketing_start_date": "20241104"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (62332-558-45)", "package_ndc": "62332-558-45", "marketing_start_date": "20241104"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62332-558-60)", "package_ndc": "62332-558-60", "marketing_start_date": "20241104"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-558-91)", "package_ndc": "62332-558-91", "marketing_start_date": "20241104"}], "brand_name": "sacubitril and valsartan", "product_id": "62332-558_3b7867cd-b65b-47b7-a000-f31f04a564aa", "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": "62332-558", "generic_name": "sacubitril and valsartan", "labeler_name": "Alembic Pharmaceuticals Inc.", "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": "ANDA213682", "marketing_category": "ANDA", "marketing_start_date": "20241104", "listing_expiration_date": "20261231"}