cetirizine hydrochloride

Product NDC
71610-862
11-digit product format
716100862
Labeler code
71610
Product ID
71610-862_25db6e82-df00-8206-e063-6294a90a5594
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2007-12-27
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-862-307161008623030 TABLET in 1 BOTTLE (71610-862-30) 30 tablet2024-10-28NoNoHistorical
71610-862-607161008626090 TABLET in 1 BOTTLE (71610-862-60) 90 tablet2024-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug FactsAphena Pharma Solutions - Tennessee, LLC2024-11-01HUMAN OTC DRUG LABEL1