CETIRIZINE HYDROCHLORIDE

Product NDC
71610-048
11-digit product format
716100048
Labeler code
71610
Product ID
71610-048_c6a3a867-12d7-4fcb-8261-d53c9189a9fe
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078317
Marketing category
ANDA
Marketing start
2016-06-22
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-048CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180419_490273bf-4a38-425c-bd62-9ba1a4173c36.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-048-607161000486090 TABLET, FILM COATED in 1 BOTTLE (71610-048-60) 2018-04-060000-00-00NoNoCurrent