sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1921
Product ID 70771-1921_f0d8c298-2823-4537-ae02-c43da2c66e67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213719
Listing Expiration 2026-12-31
Marketing Start 2025-07-08

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 707711921
Hyphenated Format 70771-1921

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 ANDA213719 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 mg/1
  • 26 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (70771-1921-4) / 10 TABLET in 1 BLISTER PACK (70771-1921-2)
  • 60 TABLET in 1 BOTTLE (70771-1921-6)
  • 180 TABLET in 1 BOTTLE (70771-1921-8)
source: ndc

Packages (3)

70771-1921-4 10 BLISTER PACK in 1 CARTON (70771-1921-4) / 10 TABLET in 1 BLISTER PACK (70771-1921-2) 70771-1921-6 60 TABLET in 1 BOTTLE (70771-1921-6) 70771-1921-8 180 TABLET in 1 BOTTLE (70771-1921-8)

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": "f0d8c298-2823-4537-ae02-c43da2c66e67", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["4c871c01-0564-411f-87e2-478aa42503cf"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1921-4)  / 10 TABLET in 1 BLISTER PACK (70771-1921-2)", "package_ndc": "70771-1921-4", "marketing_start_date": "20250708"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (70771-1921-6)", "package_ndc": "70771-1921-6", "marketing_start_date": "20250708"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (70771-1921-8)", "package_ndc": "70771-1921-8", "marketing_start_date": "20250708"}], "brand_name": "sacubitril and valsartan", "product_id": "70771-1921_f0d8c298-2823-4537-ae02-c43da2c66e67", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "70771-1921", "generic_name": "sacubitril and valsartan", "labeler_name": "Zydus Lifesciences 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": "ANDA213719", "marketing_category": "ANDA", "marketing_start_date": "20250708", "listing_expiration_date": "20261231"}