valsartan

Generic: valsartan

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

Drug Facts

Product Profile

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

valsartan 160 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5814
Product ID 0378-5814_a5384d58-48c7-494a-a8a8-c296b316bd91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090866
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

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 03785814
Hyphenated Format 0378-5814

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0303785815778 0303785813774 0303785807933 0303785814771
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 ANDA090866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5814-77)
source: ndc

Packages (1)

0378-5814-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5814-77)

Ingredients (1)

valsartan (160 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": "a5384d58-48c7-494a-a8a8-c296b316bd91", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0303785815778", "0303785813774", "0303785807933", "0303785814771"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["73e01dc6-7dd4-421a-a4f6-137e75f69f9a"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5814-77)", "package_ndc": "0378-5814-77", "marketing_start_date": "20150105"}], "brand_name": "Valsartan", "product_id": "0378-5814_a5384d58-48c7-494a-a8a8-c296b316bd91", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "0378-5814", "generic_name": "valsartan", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA090866", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}