Irbesartan and Hydrochlorothiazide

Product NDC
43547-672
11-digit product format
435470672
Labeler code
43547
Product ID
43547-672_da1c9acf-6323-4ef5-bfff-8eedc7992d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA203072
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength
25 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-672-034354706720330 TABLET in 1 BOTTLE (43547-672-03) 30 tablet2014-03-010000-00-00NoNoCurrent
43547-672-094354706720990 TABLET in 1 BOTTLE (43547-672-09) 90 tablet2014-03-010000-00-00NoNoCurrent
43547-672-5043547067250500 TABLET in 1 BOTTLE (43547-672-50) 500 tablet2014-03-010000-00-00NoNoCurrent