sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: novugen pharma (usa) llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler novugen pharma (usa) llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer
Novugen Pharma (USA) LLC

Identifiers & Regulatory

Product NDC 82293-029
Product ID 82293-029_3a16fd48-3952-6d6e-e063-6294a90aefda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213611
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

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 82293029
Hyphenated Format 82293-029

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 ANDA213611 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 97 mg/1
  • 103 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (82293-029-10)
  • 180 TABLET, FILM COATED in 1 BOTTLE (82293-029-20)
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-029-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-029-31)
source: ndc

Packages (3)

82293-029-10 60 TABLET, FILM COATED in 1 BOTTLE (82293-029-10) 82293-029-20 180 TABLET, FILM COATED in 1 BOTTLE (82293-029-20) 82293-029-30 100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-029-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-029-31)

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": "3a16fd48-3952-6d6e-e063-6294a90aefda", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["747eeb5c-ac2f-474f-b6d2-0586d12653a6"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novugen Pharma (USA) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82293-029-10)", "package_ndc": "82293-029-10", "marketing_start_date": "20250716"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (82293-029-20)", "package_ndc": "82293-029-20", "marketing_start_date": "20250716"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-029-30)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-029-31)", "package_ndc": "82293-029-30", "marketing_start_date": "20250716"}], "brand_name": "Sacubitril and Valsartan", "product_id": "82293-029_3a16fd48-3952-6d6e-e063-6294a90aefda", "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": "82293-029", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Novugen Pharma (USA) LLC", "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": "ANDA213611", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}