Cetirizine Hydrochloride

Product NDC
0904-5852
11-digit product format
009045852
Labeler code
0904
Product ID
0904-5852_6d815389-b3c5-4e07-a2d1-56a3a24dc5fe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078317
Marketing category
ANDA
Marketing start
2007-12-27
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5852-41EA - Each0904-5852c71dfcb5-b358-49c2-8db5-d36bbc82b74712012-07-24
0904-5852-43EA - Each0904-5852dd0c3d1a-fa4b-4f5e-9502-63fccd9cda9112012-07-24
0904-5852-46EA - Each0904-58529ff69f53-bd24-41bc-9078-05598609daf612012-07-24
0904-5852-60EA - Each0904-5852cf88e663-2446-4d9e-9e0e-59d5931478ef12012-07-24
0904-5852-61EA - Each0904-5852dde6ff3d-dc9f-4bda-afc0-c6e130914e7112013-02-13
0904-5852-72EA - Each0904-5852efbd5a2b-d5d7-4841-9d15-6444b5bf02dc12016-08-09
0904-5852-89EA - Each0904-5852ca6650ca-9815-4a54-9df0-3d02f3f3aedc12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-5852-7200904585272300 TABLET, FILM COATED in 1 BOTTLE (0904-5852-72) 2016-06-232021-04-30NoNoCurrent