Valsartan and Hydrochlorothiazide

Product NDC
68788-7887
11-digit product format
687887887
Labeler code
68788
Product ID
68788-7887_42efba66-aa61-44df-9b20-bbda8944827f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078020
Marketing category
ANDA
Marketing start
2021-04-16
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
13 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7887-36878878870330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7887-3) 2021-04-160000-00-00NoNoCurrent
68788-7887-66878878870660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7887-6) 2021-04-160000-00-00NoNoCurrent
68788-7887-96878878870990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7887-9) 2021-04-160000-00-00NoNoCurrent