Cetirizine Hydrochloride (Allergy Relief)

Product NDC
55315-007
11-digit product format
553150007
Labeler code
55315
Product ID
55315-007_f0af4536-fbcb-462b-8264-3ea0bb865238
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Fred's, Inc.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-007-09553150007091 BOTTLE in 1 CARTON (55315-007-09) > 30 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent