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
Routes
ORAL
Active Ingredients

valsartan 320 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-655
Product ID 63187-655_0e31e187-683b-437f-91b6-d14cd11882bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204821
Listing Expiration 2026-12-31
Marketing Start 2015-08-31

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 63187655
Hyphenated Format 63187-655

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 ANDA204821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 320 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-655-30)
  • 60 TABLET in 1 BOTTLE (63187-655-60)
  • 90 TABLET in 1 BOTTLE (63187-655-90)
source: ndc

Packages (3)

63187-655-30 30 TABLET in 1 BOTTLE (63187-655-30) 63187-655-60 60 TABLET in 1 BOTTLE (63187-655-60) 63187-655-90 90 TABLET in 1 BOTTLE (63187-655-90)

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": "0e31e187-683b-437f-91b6-d14cd11882bf", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349200"], "spl_set_id": ["b58471fe-e2c6-4cc5-9d49-6a3111f6e002"], "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 in 1 BOTTLE (63187-655-30)", "package_ndc": "63187-655-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-655-60)", "package_ndc": "63187-655-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-655-90)", "package_ndc": "63187-655-90", "marketing_start_date": "20181201"}], "brand_name": "Valsartan", "product_id": "63187-655_0e31e187-683b-437f-91b6-d14cd11882bf", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "63187-655", "generic_name": "valsartan", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA204821", "marketing_category": "ANDA", "marketing_start_date": "20150831", "listing_expiration_date": "20261231"}