valsartan

Generic: valsartan

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valsartan 80 mg/1

Manufacturer
ScieGen Pharmaceuticals, INC.

Identifiers & Regulatory

Product NDC 50228-134
Product ID 50228-134_f1da8d58-f8d8-3616-e053-2995a90a27ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204038
Listing Expiration 2026-12-31
Marketing Start 2021-10-27

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 50228134
Hyphenated Format 50228-134

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0350228133104 0350228133302 0350228132305 0350228132053 0350228135306 0350228134101 0350228135108
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 ANDA204038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (50228-134-10)
  • 30 TABLET in 1 BOTTLE (50228-134-30)
source: ndc

Packages (2)

50228-134-10 1000 TABLET in 1 BOTTLE (50228-134-10) 50228-134-30 30 TABLET in 1 BOTTLE (50228-134-30)

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": "f1da8d58-f8d8-3616-e053-2995a90a27ea", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0350228133104", "0350228133302", "0350228132305", "0350228132053", "0350228135306", "0350228134101", "0350228135108"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["1a8af3d9-4053-4233-82a7-e8c7bc9e302f"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["ScieGen Pharmaceuticals, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-134-10)", "package_ndc": "50228-134-10", "marketing_start_date": "20211027"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-134-30)", "package_ndc": "50228-134-30", "marketing_start_date": "20211027"}], "brand_name": "Valsartan", "product_id": "50228-134_f1da8d58-f8d8-3616-e053-2995a90a27ea", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50228-134", "generic_name": "Valsartan", "labeler_name": "ScieGen Pharmaceuticals, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "80 mg/1"}], "application_number": "ANDA204038", "marketing_category": "ANDA", "marketing_start_date": "20211027", "listing_expiration_date": "20261231"}