Cetirizine Hydrochloride

Product NDC
68071-2482
11-digit product format
680712482
Labeler code
68071
Product ID
68071-2482_c7d1829b-2cf2-aeed-e053-2a95a90ae11a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2482-36807124820330 TABLET in 1 BOTTLE (68071-2482-3) 30 tablet2021-07-230000-00-00NoNoCurrent
68071-2482-7680712482077 TABLET in 1 BOTTLE (68071-2482-7) 7 tablet2021-07-230000-00-00NoNoCurrent
68071-2482-96807124820990 TABLET in 1 BOTTLE (68071-2482-9) 90 tablet2021-07-230000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cetirizine Hydrochloride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-07-23HUMAN OTC DRUG LABEL1