sacubitril and valsartan (70771-1923)

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 97 mg/1, valsartan 103 mg/1

Manufacturer

Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1923

Product ID 70771-1923_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 707711923

Hyphenated Format 70771-1923

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

97 mg/1
103 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (70771-1923-4) / 10 TABLET in 1 BLISTER PACK (70771-1923-2)
60 TABLET in 1 BOTTLE (70771-1923-6)
180 TABLET in 1 BOTTLE (70771-1923-8)

source: ndc

Packages (3)

70771-1923-4 10 BLISTER PACK in 1 CARTON (70771-1923-4) / 10 TABLET in 1 BLISTER PACK (70771-1923-2) 70771-1923-6 60 TABLET in 1 BOTTLE (70771-1923-6) 70771-1923-8 180 TABLET in 1 BOTTLE (70771-1923-8)

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": "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 (70771-1923-4)  / 10 TABLET in 1 BLISTER PACK (70771-1923-2)", "package_ndc": "70771-1923-4", "marketing_start_date": "20250708"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (70771-1923-6)", "package_ndc": "70771-1923-6", "marketing_start_date": "20250708"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (70771-1923-8)", "package_ndc": "70771-1923-8", "marketing_start_date": "20250708"}], "brand_name": "sacubitril and valsartan", "product_id": "70771-1923_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": "70771-1923", "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": "97 mg/1"}, {"name": "VALSARTAN", "strength": "103 mg/1"}], "application_number": "ANDA213719", "marketing_category": "ANDA", "marketing_start_date": "20250708", "listing_expiration_date": "20261231"}