valsartan

Generic: valsartan

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

Drug Facts

Product Profile

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

valsartan 40 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-276
Product ID 68180-276_b0ac78ab-2315-4aca-a405-bd86b8a08692
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201677
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 68180276
Hyphenated Format 68180-276

Supplemental Identifiers

RxCUI
349199 349200 349201 349483
UPC
0368180279099 0368180278092
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 ANDA201677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan Tablets USP are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. Valsartan Tablets USP containing 40 mg of valsartan, are yellow, capsule shaped, film-coated, biconvex tablets debossed with 'L' and 'U' on either side of scoreline on one side and 'G11' on the other side. They are supplied as follows: NDC 68180-276-06 Bottle of 30s NDC 68180-276-01 Bottle of 100s NDC 68180-276-13 100 Tablets (10 X 10 Unit-dose) Valsartan Tablets USP containing 80 mg of valsartan, are pink, capsule shaped, film-coated, biconvex tablets debossed with 'LU' on one side and 'G12' on the other side. They are supplied as follows: NDC 68180-277-09 Bottle of 90s NDC 68180-277-03 Bottle of 1000s Valsartan Tablets USP containing 160 mg of valsartan, are dark yellow, capsule shaped, film-coated, biconvex tablets debossed with 'LU' on one side and 'G13' on the other side. They are supplied as follows: NDC 68180-278-09 Bottle of 90s NDC 68180-278-03 Bottle of 1000s Valsartan Tablets USP containing 320 mg of valsartan, are tan colored, capsule shaped, film-coated, biconvex tablets debossed with 'LU' on one side and 'G14' on the other side. They are supplied as follows: NDC 68180-279-09 Bottle of 90s NDC 68180-279-02 Bottle of 500s Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Valsartan Tablets 40 mg NDC 68180-276-11 Blister Strip of 10s Valsartan Tablets 40 mg NDC 68180-276-13 Carton of 100s (10 Blister Strips of 10 Tablets Each) Valsartan Tablets 40 mg NDC 68180-276-06 Bottle of 30s Valsartan Tablets 80 mg NDC 68180-277-09 Bottle of 90s Valsartan Tablets 160 mg NDC 68180-278-09 Bottle of 90s Valsartan Tablets 320 mg NDC 68180-279-09 Bottle of 90s image02 image03 image-05 image-06 image-07 image-08
source: label

Packages (0)

No package records.

Ingredients (1)

valsartan (40 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": "b0ac78ab-2315-4aca-a405-bd86b8a08692", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0368180279099", "0368180278092"], "unii": ["80M03YXJ7I"], "rxcui": ["349199", "349200", "349201", "349483"], "spl_set_id": ["9eb9d98e-7057-4ca0-91ab-2030bc0120a6"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Valsartan", "product_id": "68180-276_b0ac78ab-2315-4aca-a405-bd86b8a08692", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68180-276", "generic_name": "Valsartan", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "40 mg/1"}], "application_number": "ANDA201677", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}