sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-955
Product ID 71610-955_4134b078-47c2-9e82-e063-6294a90aaaee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213748
Listing Expiration 2026-12-31
Marketing Start 2025-01-21

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 71610955
Hyphenated Format 71610-955

Supplemental Identifiers

RxCUI
1656354
UNII
17ERJ0MKGI 80M03YXJ7I
NUI
N0000000070 N0000175561

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 ANDA213748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 97 mg/1
  • 103 mg/1
source: ndc
Packaging
  • 3060 TABLET, FILM COATED in 1 BOTTLE (71610-955-19)
source: ndc

Packages (1)

71610-955-19 3060 TABLET, FILM COATED in 1 BOTTLE (71610-955-19)

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": "4134b078-47c2-9e82-e063-6294a90aaaee", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["17ERJ0MKGI", "80M03YXJ7I"], "rxcui": ["1656354"], "spl_set_id": ["4134afd2-a0a0-a64a-e063-6394a90ae580"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3060 TABLET, FILM COATED in 1 BOTTLE (71610-955-19)", "package_ndc": "71610-955-19", "marketing_start_date": "20251014"}], "brand_name": "Sacubitril and Valsartan", "product_id": "71610-955_4134b078-47c2-9e82-e063-6294a90aaaee", "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": "71610-955", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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": "ANDA213748", "marketing_category": "ANDA", "marketing_start_date": "20250121", "listing_expiration_date": "20261231"}