Cetirizine Hydrochloride

Product NDC
0378-3637
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076677
Marketing category
ANDA
Substance
CETIRIZINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
0378-3637-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) 2007-12-27NoHistorical
0378-3637-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05) 2007-12-27NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsSafecor Health, LLC2026-05-01HUMAN OTC DRUG LABEL2
Drug FactsMylan Institutional Inc.2025-07-18HUMAN OTC DRUG LABEL12
Drug FactsMylan Pharmaceuticals Inc.2022-01-12HUMAN OTC DRUG LABEL10
Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTSApotheca Inc.2010-04-07HUMAN OTC DRUG LABEL2