Core Values Allergy Relief

Product NDC
63940-043
11-digit product format
639400043
Labeler code
63940
Product ID
63940-043_6ccf23ae-8475-40b3-b383-49afb4d46ffb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Harmon Stores Inc.
Application
ANDA078336
Marketing category
ANDA
Marketing start
2016-11-22
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63940-043-39639400043391 BOTTLE in 1 CARTON (63940-043-39) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-220000-00-00NoNoCurrent
63940-043-666394000436614 BLISTER PACK in 1 CARTON (63940-043-66) > 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2016-11-220000-00-00NoNoCurrent