Cetirizine Hydrochloride (Allergy)

Product NDC
80539-002
11-digit product format
805390002
Labeler code
80539
Product ID
80539-002_92a39c1f-65ef-4ab1-913d-a13fa4c2fd41
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Allwell Health Inc
Application
ANDA090760
Marketing category
ANDA
Marketing start
2021-02-15
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80539-002-09805390002091 BOTTLE in 1 CARTON (80539-002-09) > 30 TABLET in 1 BOTTLE1 bottle2021-02-150000-00-00NoNoCurrent