valsartan

Generic: valsartan

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

Drug Facts

Product Profile

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

valsartan 320 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1574
Product ID 67046-1574_3dfe5365-55f0-0faa-e063-6394a90adda5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203311
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

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 670461574
Hyphenated Format 67046-1574

Supplemental Identifiers

RxCUI
349200
UNII
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 valsartan (source: ndc)
Generic Name valsartan (source: ndc)
Application Number ANDA203311 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 320 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1574-3)
source: ndc

Packages (1)

67046-1574-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1574-3)

Ingredients (1)

valsartan (320 mg/1)

Linked Drug Pages (1)

Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3dfe5365-55f0-0faa-e063-6394a90adda5", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349200"], "spl_set_id": ["3dfe5407-96a6-d2f4-e063-6294a90aa810"], "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 (67046-1574-3)", "package_ndc": "67046-1574-3", "marketing_start_date": "20250904"}], "brand_name": "Valsartan", "product_id": "67046-1574_3dfe5365-55f0-0faa-e063-6394a90adda5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "67046-1574", "generic_name": "Valsartan", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA203311", "marketing_category": "ANDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}