Irbesartan and Hydrochlorothiazide

Product NDC
71335-2099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203072
Marketing category
ANDA
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
71335-2099-130 TABLET in 1 BOTTLE (71335-2099-1) 20220606NoHistorical
71335-2099-290 TABLET in 1 BOTTLE (71335-2099-2) 20220606NoHistorical
71335-2099-328 TABLET in 1 BOTTLE (71335-2099-3) 20220606NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
85494404-484c-45a1-8487-f9eb2a76490dThese highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997Bryant Ranch Prepack2023-11-14HUMAN PRESCRIPTION DRUG LABEL102