valsartan and hydrochlorothiazide

Product NDC
68382-280
11-digit product format
683820280
Labeler code
68382
Product ID
68382-280_84d7e724-d8f9-4ced-9013-b064226d482d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA203000
Marketing category
ANDA
Marketing start
2020-02-12
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
160 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-280-10683820280101000 TABLET, FILM COATED in 1 BOTTLE (68382-280-10) 2020-02-120000-00-00NoNoCurrent
68382-280-166838202801690 TABLET, FILM COATED in 1 BOTTLE (68382-280-16) 2020-02-120000-00-00NoNoCurrent
68382-280-776838202807710 BLISTER PACK in 1 CARTON (68382-280-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-280-30) 10 blister pack2020-02-120000-00-00NoNoCurrent