Diovan HCT

Product NDC
55289-838
11-digit product format
552890838
Labeler code
55289
Product ID
55289-838_e238472f-03a8-b904-e053-2995a90aec5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020818
Marketing category
NDA
Marketing start
1998-03-06
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-838-30EA - Each55289-83895da964b-19a4-46cb-a8f6-2016397e3b3912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-838-305528908383030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-838-30) 2012-02-220000-00-00NoNoCurrent