sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: lupin 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 lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-195
Product ID 70748-195_e8c2bfce-cd97-4f79-a4e7-0c9ed648d7fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213808
Listing Expiration 2026-12-31
Marketing Start 2025-07-29

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 70748195
Hyphenated Format 70748-195

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UPC
0370748196076 0370748195079 0370748197073
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 ANDA213808 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 mg/1
  • 26 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (70748-195-07)
source: ndc

Packages (1)

70748-195-07 60 TABLET, FILM COATED in 1 BOTTLE (70748-195-07)

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": "e8c2bfce-cd97-4f79-a4e7-0c9ed648d7fa", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0370748196076", "0370748195079", "0370748197073"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["76cbb87b-6356-4ead-af7f-faffb6e79743"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70748-195-07)", "package_ndc": "70748-195-07", "marketing_start_date": "20250729"}], "brand_name": "sacubitril and valsartan", "product_id": "70748-195_e8c2bfce-cd97-4f79-a4e7-0c9ed648d7fa", "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": "70748-195", "generic_name": "sacubitril and valsartan", "labeler_name": "Lupin Pharmaceuticals, Inc.", "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": "ANDA213808", "marketing_category": "ANDA", "marketing_start_date": "20250729", "listing_expiration_date": "20261231"}