Cetirizine Hydrochloride

Product NDC
51079-597
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076677
Marketing category
ANDA
Substance
CETIRIZINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
51079-597-20100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01) 2012-03-30NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsCardinal Health 107, LLC2026-04-28HUMAN OTC DRUG LABEL14
Drug FactsMylan Institutional Inc.2025-07-18HUMAN OTC DRUG LABEL12