valsartan

Generic: valsartan

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

valsartan 80 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-063
Product ID 33342-063_1fff1472-c659-469c-8786-f3c9b6689524
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202696
Listing Expiration 2026-12-31
Marketing Start 2016-09-19

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 33342063
Hyphenated Format 33342-063

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0333342065100 0333342064103 0333342064790 0333342062079 0333342063106 0333342062772 0333342065803 0333342063786
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 ANDA202696 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-063-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-063-44)
source: ndc

Packages (2)

33342-063-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-063-10) 33342-063-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-063-44)

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": "1fff1472-c659-469c-8786-f3c9b6689524", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0333342065100", "0333342064103", "0333342064790", "0333342062079", "0333342063106", "0333342062772", "0333342065803", "0333342063786"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["251ccff4-bf86-453b-9d1c-e3c1ecfd3a46"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-063-10)", "package_ndc": "33342-063-10", "marketing_start_date": "20160919"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-063-44)", "package_ndc": "33342-063-44", "marketing_start_date": "20160919"}], "brand_name": "Valsartan", "product_id": "33342-063_1fff1472-c659-469c-8786-f3c9b6689524", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "33342-063", "generic_name": "Valsartan", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "80 mg/1"}], "application_number": "ANDA202696", "marketing_category": "ANDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}