Label: VALSARTAN AND HYDROCHLOROTHIAZIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-951-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 65862-551
- 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: 51655-951-52
MFG: 65862-551-90
Valsartan HCTZ
320mg/25mg
30 Tablets
Rx only
Lot# NW48300001
Exp Date: 12/2015
Each tablet contains: 320mg of Valsartan and 25mg of Hydrochlorothiazide, USP
Dosage: See package insert
Store at 68 to 77 degreesF.
Store in a tight, light-resistant container (See USP)
Keep out of reach of children.
MFG by: Aurobindo Pharma Limited, Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, India
MFG for: Aurobindo Pharma USA, Inc, 2400 Route 130 North, Dayton, NJ 08810 LotL HTSB14004-A
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-951(NDC:65862-551) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 320 mg in 30 HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 25 mg in 30 Product Characteristics Color yellow Score no score Shape OVAL Size 22mm Flavor Imprint Code I65 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-951-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202519 05/06/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-951)