valsartan

Generic: valsartan

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valsartan 160 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-154
Product ID 82804-154_c64664c5-0981-4086-a933-c9c46d34167f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203311
Listing Expiration 2026-12-31
Marketing Start 2021-06-23

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 82804154
Hyphenated Format 82804-154

Supplemental Identifiers

RxCUI
349201
UPC
0382804154906
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
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82804-154-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-154-90)
source: ndc

Packages (2)

Ingredients (1)

valsartan (160 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c64664c5-0981-4086-a933-c9c46d34167f", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0382804154906"], "unii": ["80M03YXJ7I"], "rxcui": ["349201"], "spl_set_id": ["f59f71d3-c143-43e5-ac22-0b1d741f4a81"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-154-30)", "package_ndc": "82804-154-30", "marketing_start_date": "20250218"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-154-90)", "package_ndc": "82804-154-90", "marketing_start_date": "20241003"}], "brand_name": "Valsartan", "product_id": "82804-154_c64664c5-0981-4086-a933-c9c46d34167f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "82804-154", "generic_name": "Valsartan", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA203311", "marketing_category": "ANDA", "marketing_start_date": "20210623", "listing_expiration_date": "20261231"}