Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)

Product NDC
25000-160
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA078933
Marketing category
ANDA
Substance
CETIRIZINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
25000-160-031 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLE2025-04-10NoHistorical
25000-160-141000 TABLET in 1 BOTTLE (25000-160-14) 2025-04-10NoHistorical
25000-160-811 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACK2025-04-10NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Allergy Relief Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mgMARKSANS PHARMA LIMITED2025-07-31Human OTC Drug Label13