sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: alembic pharmaceuticals limited
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 limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-556
Product ID 46708-556_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d
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 46708556
Hyphenated Format 46708-556

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UPC
0346708558604
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
  • 24 mg/1
  • 26 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-556-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 180 TABLET, FILM COATED in 1 BOTTLE (46708-556-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (46708-556-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-556-91)
source: ndc

Packages (4)

46708-556-10 100 BLISTER PACK in 1 CARTON (46708-556-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-556-45 180 TABLET, FILM COATED in 1 BOTTLE (46708-556-45) 46708-556-60 60 TABLET, FILM COATED in 1 BOTTLE (46708-556-60) 46708-556-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-556-91)

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": "e4716fc9-5f73-4303-8a4e-e8f9129b6e2d", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0346708558604"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["e4716fc9-5f73-4303-8a4e-e8f9129b6e2d"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-556-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-556-10", "marketing_start_date": "20241104"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (46708-556-45)", "package_ndc": "46708-556-45", "marketing_start_date": "20241104"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (46708-556-60)", "package_ndc": "46708-556-60", "marketing_start_date": "20241104"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-556-91)", "package_ndc": "46708-556-91", "marketing_start_date": "20241104"}], "brand_name": "sacubitril and valsartan", "product_id": "46708-556_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d", "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": "46708-556", "generic_name": "sacubitril and valsartan", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "ANDA213682", "marketing_category": "ANDA", "marketing_start_date": "20241104", "listing_expiration_date": "20261231"}