Irbesartan and Hydrochlorothiazide

Product NDC
70518-2619
11-digit product format
705182619
Labeler code
70518
Product ID
70518-2619_dc64ef66-bb98-973a-e053-2995a90ad8bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077369
Marketing category
ANDA
Marketing start
2020-03-09
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
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
70518-2619-07051826190090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2619-0) 2020-03-090000-00-00NoNoCurrent