valsartan

Generic: valsartan

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valsartan 80 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-838
Product ID 65162-838_ce6ac5f2-be9c-461a-b749-5a2e24552878
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204011
Listing Expiration 2026-12-31
Marketing Start 2016-01-27

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 65162838
Hyphenated Format 65162-838

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0365162837506 0365162838503 0365162839500 0365162840506
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 ANDA204011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (65162-838-09)
  • 1000 TABLET in 1 BOTTLE (65162-838-11)
  • 500 TABLET in 1 BOTTLE (65162-838-50)
source: ndc

Packages (3)

65162-838-09 90 TABLET in 1 BOTTLE (65162-838-09) 65162-838-11 1000 TABLET in 1 BOTTLE (65162-838-11) 65162-838-50 500 TABLET in 1 BOTTLE (65162-838-50)

Ingredients (1)

valsartan (80 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": "ce6ac5f2-be9c-461a-b749-5a2e24552878", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0365162837506", "0365162838503", "0365162839500", "0365162840506"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["f4a5df78-157b-4996-845c-235234250f11"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-838-09)", "package_ndc": "65162-838-09", "marketing_start_date": "20160127"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-838-11)", "package_ndc": "65162-838-11", "marketing_start_date": "20160127"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-838-50)", "package_ndc": "65162-838-50", "marketing_start_date": "20160127"}], "brand_name": "Valsartan", "product_id": "65162-838_ce6ac5f2-be9c-461a-b749-5a2e24552878", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "65162-838", "generic_name": "Valsartan", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "80 mg/1"}], "application_number": "ANDA204011", "marketing_category": "ANDA", "marketing_start_date": "20160127", "listing_expiration_date": "20261231"}