valsartan

Generic: valsartan

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

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler square pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valsartan 80 mg/1

Manufacturer
SQUARE PHARMACEUTICALS LIMITED

Identifiers & Regulatory

Product NDC 76483-023
Product ID 76483-023_9f718442-a70e-4f30-8a1e-456392400ec0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205347
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 76483023
Hyphenated Format 76483-023

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
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 ANDA205347 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76483-023-00)
  • 90 TABLET in 1 BOTTLE (76483-023-03)
  • 100 TABLET in 1 BOTTLE (76483-023-04)
  • 500 TABLET in 1 BOTTLE (76483-023-05)
  • 1000 TABLET in 1 BOTTLE (76483-023-06)
source: ndc

Packages (5)

76483-023-00 30 TABLET in 1 BOTTLE (76483-023-00) 76483-023-03 90 TABLET in 1 BOTTLE (76483-023-03) 76483-023-04 100 TABLET in 1 BOTTLE (76483-023-04) 76483-023-05 500 TABLET in 1 BOTTLE (76483-023-05) 76483-023-06 1000 TABLET in 1 BOTTLE (76483-023-06)

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": "9f718442-a70e-4f30-8a1e-456392400ec0", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["5ee97546-2a7c-40fa-9e05-b7993a72dfbf"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["SQUARE PHARMACEUTICALS LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76483-023-00)", "package_ndc": "76483-023-00", "marketing_start_date": "20220715"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76483-023-03)", "package_ndc": "76483-023-03", "marketing_start_date": "20220715"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (76483-023-04)", "package_ndc": "76483-023-04", "marketing_start_date": "20220715"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76483-023-05)", "package_ndc": "76483-023-05", "marketing_start_date": "20220715"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76483-023-06)", "package_ndc": "76483-023-06", "marketing_start_date": "20220715"}], "brand_name": "Valsartan", "product_id": "76483-023_9f718442-a70e-4f30-8a1e-456392400ec0", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "76483-023", "generic_name": "Valsartan", "labeler_name": "SQUARE PHARMACEUTICALS LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "80 mg/1"}], "application_number": "ANDA205347", "marketing_category": "ANDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}