sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 24 mg/1, valsartan 26 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1624
Product ID 67046-1624_48c0e508-e68a-3d43-e063-6294a90a3ade
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213682
Listing Expiration 2027-12-31
Marketing Start 2025-12-16

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 670461624
Hyphenated Format 67046-1624

Supplemental Identifiers

RxCUI
1656340
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 ANDA213682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 mg/1
  • 26 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1624-3)
source: ndc

Packages (1)

67046-1624-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1624-3)

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": "48c0e508-e68a-3d43-e063-6294a90a3ade", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["17ERJ0MKGI", "80M03YXJ7I"], "rxcui": ["1656340"], "spl_set_id": ["46154d5f-7de1-db5e-e063-6394a90af86e"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1624-3)", "package_ndc": "67046-1624-3", "marketing_start_date": "20251216"}], "brand_name": "sacubitril and valsartan", "product_id": "67046-1624_48c0e508-e68a-3d43-e063-6294a90a3ade", "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": "67046-1624", "generic_name": "sacubitril and valsartan", "labeler_name": "Coupler LLC", "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": "ANDA213682", "marketing_category": "ANDA", "marketing_start_date": "20251216", "listing_expiration_date": "20271231"}