valsartan

Generic: valsartan

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valsartan 320 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-134
Product ID 72578-134_08731c4e-5c0c-4fba-b250-dbd17fd36e6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218991
Listing Expiration 2026-12-31
Marketing Start 2024-08-30

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 72578134
Hyphenated Format 72578-134

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0372578131067 0372578134167
UNII
80M03YXJ7I
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 valsartan (source: ndc)
Generic Name valsartan (source: ndc)
Application Number ANDA218991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 320 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (72578-134-16)
source: ndc

Packages (1)

72578-134-16 90 TABLET, FILM COATED in 1 BOTTLE (72578-134-16)

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": "08731c4e-5c0c-4fba-b250-dbd17fd36e6e", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0372578131067", "0372578134167"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["bd7b35c7-9f01-4afd-b497-bbe0f3d69b29"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72578-134-16)", "package_ndc": "72578-134-16", "marketing_start_date": "20240830"}], "brand_name": "Valsartan", "product_id": "72578-134_08731c4e-5c0c-4fba-b250-dbd17fd36e6e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "72578-134", "generic_name": "Valsartan", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA218991", "marketing_category": "ANDA", "marketing_start_date": "20240830", "listing_expiration_date": "20261231"}