Irbesartan and Hydrochlorothiazide

Product NDC
42291-342
11-digit product format
422910342
Labeler code
42291
Product ID
42291-342_c7026713-be19-7fda-e053-2a95a90a2717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA077369
Marketing category
ANDA
Marketing start
2013-07-22
Marketing end
0000-00-00
Substance
IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength
150 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-342-90EA - Each42291-3429e1ba39d-d2e0-45ca-809e-cb80cb7f67ab12013-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-342-904229103429090 TABLET, FILM COATED in 1 BOTTLE (42291-342-90) 2013-07-220000-00-00NoNoCurrent