Label: VALSARTAN HCTZ tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-950-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0591-2316
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 6, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-950-52
MFG: 0591-2316-10
Valsartan HCTZ
160/12.5MG
30 tablets
Rx only
Lot# NW23790001
Exp Date: 02/2015
Each tablet contains: 160mg of Valsartan and 12.5mg of hydrochlorothiazide, USP
Dosage: See package insert
Store at 68 to 77 degrees F.
Store in a tight, light-resistant container (See USP)
Keep out of reach of children.
Mfg by: Arrow Pharm (Malta) Ltd. Birzebbugia, BBG06, Malta
Distr. by: Watson Pharma, Inc Parsippany, NJ 07054 USA Lot# 3019329
Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
VALSARTAN HCTZ
valsartan hctz tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-950(NDC:0591-2316) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 160 mg in 30 HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg in 30 Product Characteristics Color red Score no score Shape OVAL Size 15mm Flavor Imprint Code VH2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-950-52 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091519 05/06/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-950)