valsartan

Generic: valsartan

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valsartan 160 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-634
Product ID 60687-634_23562661-facc-865c-e063-6394a90af4c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205536
Listing Expiration 2026-12-31
Marketing Start 2021-06-25

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 60687634
Hyphenated Format 60687-634

Supplemental Identifiers

RxCUI
349199 349201 349483
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 ANDA205536 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-634-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-634-11)
source: ndc

Packages (1)

60687-634-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-634-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-634-11)

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": "23562661-facc-865c-e063-6394a90af4c0", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349201", "349483"], "spl_set_id": ["7ea2fdf1-4fda-47a7-8110-62fb6468c989"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-634-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-634-11)", "package_ndc": "60687-634-01", "marketing_start_date": "20210625"}], "brand_name": "Valsartan", "product_id": "60687-634_23562661-facc-865c-e063-6394a90af4c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "60687-634", "generic_name": "Valsartan", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA205536", "marketing_category": "ANDA", "marketing_start_date": "20210625", "listing_expiration_date": "20261231"}