valsartan

Generic: valsartan

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valsartan 80 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-010
Product ID 82868-010_46dc9144-f123-9107-e063-6394a90a51a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203311
Listing Expiration 2026-12-31
Marketing Start 2023-08-31

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 82868010
Hyphenated Format 82868-010

Supplemental Identifiers

RxCUI
349199
UNII
80M03YXJ7I
NUI
N0000000070 N0000175561

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 ANDA203311 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-010-30)
source: ndc

Packages (1)

82868-010-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-010-30)

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": "46dc9144-f123-9107-e063-6394a90a51a7", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349199"], "spl_set_id": ["04b3301f-e054-ed5d-e063-6294a90a819c"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-010-30)", "package_ndc": "82868-010-30", "marketing_start_date": "20230831"}], "brand_name": "Valsartan", "product_id": "82868-010_46dc9144-f123-9107-e063-6394a90a51a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "82868-010", "generic_name": "Valsartan", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "80 mg/1"}], "application_number": "ANDA203311", "marketing_category": "ANDA", "marketing_start_date": "20230831", "listing_expiration_date": "20261231"}