sacubitril and valsartan (70377-032)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler biocon pharma inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer

Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-032

Product ID 70377-032_600f67e2-7ccf-65d9-012c-e7ba9b8a089f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213680

Listing Expiration 2026-12-31

Marketing Start 2025-07-17

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 70377032

Hyphenated Format 70377-032

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0370377031144 0370377031120

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 ANDA213680 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

49 mg/1
51 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (70377-032-11)
60 TABLET, FILM COATED in 1 BOTTLE (70377-032-12)
180 TABLET, FILM COATED in 1 BOTTLE (70377-032-13)
500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14)

source: ndc

Packages (4)

70377-032-11 30 TABLET, FILM COATED in 1 BOTTLE (70377-032-11) 70377-032-12 60 TABLET, FILM COATED in 1 BOTTLE (70377-032-12) 70377-032-13 180 TABLET, FILM COATED in 1 BOTTLE (70377-032-13) 70377-032-14 500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14)

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": "600f67e2-7ccf-65d9-012c-e7ba9b8a089f", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0370377031144", "0370377031120"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["7de9b8e0-195a-b59e-7bbf-3e95c4096af9"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70377-032-11)", "package_ndc": "70377-032-11", "marketing_start_date": "20250717"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70377-032-12)", "package_ndc": "70377-032-12", "marketing_start_date": "20250717"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (70377-032-13)", "package_ndc": "70377-032-13", "marketing_start_date": "20250717"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14)", "package_ndc": "70377-032-14", "marketing_start_date": "20250717"}], "brand_name": "Sacubitril and Valsartan", "product_id": "70377-032_600f67e2-7ccf-65d9-012c-e7ba9b8a089f", "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": "70377-032", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Biocon Pharma 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": "ANDA213680", "marketing_category": "ANDA", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}