Cetirizine Hydrochloride

Product NDC
68071-2570
11-digit product format
680712570
Labeler code
68071
Product ID
68071-2570_d0d86f58-9028-077e-e053-2995a90ad40b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
64O047KTOACETIRIZINE HYDROCHLORIDE83881-52-1CETIRIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2570-36807125700330 TABLET, FILM COATED in 1 BOTTLE (68071-2570-3) 2021-11-150000-00-00NoNoCurrent
68071-2570-7680712570077 TABLET, FILM COATED in 1 BOTTLE (68071-2570-7) 2021-11-150000-00-00NoNoCurrent
68071-2570-96807125700990 TABLET, FILM COATED in 1 BOTTLE (68071-2570-9) 2021-11-150000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cetirizine Hydrochloride TabletsNuCare Pharmaceuticals,Inc.2023-07-17HUMAN OTC DRUG LABEL3