valsartan

Generic: valsartan

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valsartan 40 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-746
Product ID 50268-746_2b4bed38-a3f8-00ef-e063-6394a90afba8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203311
Listing Expiration 2026-12-31
Marketing Start 2023-10-24

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 50268746
Hyphenated Format 50268-746

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
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
  • 40 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-746-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-746-11)
source: ndc

Packages (1)

50268-746-15 50 BLISTER PACK in 1 BOX (50268-746-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-746-11)

Ingredients (1)

valsartan (40 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": "2b4bed38-a3f8-00ef-e063-6394a90afba8", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["0878f27e-5368-c93f-e063-6394a90a1086"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-746-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-746-11)", "package_ndc": "50268-746-15", "marketing_start_date": "20231024"}], "brand_name": "Valsartan", "product_id": "50268-746_2b4bed38-a3f8-00ef-e063-6394a90afba8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50268-746", "generic_name": "Valsartan", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "40 mg/1"}], "application_number": "ANDA203311", "marketing_category": "ANDA", "marketing_start_date": "20231024", "listing_expiration_date": "20261231"}