valsartan

Generic: valsartan

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

Drug Facts

Product Profile

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

valsartan 80 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-838
Product ID 53746-838_254b9473-bbcb-4780-a182-ba287b886a47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204011
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 53746838
Hyphenated Format 53746-838

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0353746840905 0353746838902 0353746837301
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
  • 500 TABLET in 1 BOTTLE (53746-838-05)
  • 1000 TABLET in 1 BOTTLE (53746-838-10)
  • 90 TABLET in 1 BOTTLE (53746-838-90)
source: ndc

Packages (3)

53746-838-05 500 TABLET in 1 BOTTLE (53746-838-05) 53746-838-10 1000 TABLET in 1 BOTTLE (53746-838-10) 53746-838-90 90 TABLET in 1 BOTTLE (53746-838-90)

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": "254b9473-bbcb-4780-a182-ba287b886a47", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0353746840905", "0353746838902", "0353746837301"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["f13587f8-76cb-49ad-9291-5907249d6b8e"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-838-05)", "package_ndc": "53746-838-05", "marketing_start_date": "20230801"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-838-10)", "package_ndc": "53746-838-10", "marketing_start_date": "20230801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (53746-838-90)", "package_ndc": "53746-838-90", "marketing_start_date": "20230801"}], "brand_name": "Valsartan", "product_id": "53746-838_254b9473-bbcb-4780-a182-ba287b886a47", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "53746-838", "generic_name": "Valsartan", "labeler_name": "Amneal Pharmaceuticals of New York 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": "20230801", "listing_expiration_date": "20261231"}