NDC 71335-1090

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Cetirizine Hydrochloride.

Product ID71335-1090_6389f1df-fb08-4efd-86fc-d3462dda66a3
NDC71335-1090
Product TypeHuman Otc Drug
Proprietary NameCetirizine Hydrochloride
Generic NameCetirizine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA077829
Labeler NameBryant Ranch Prepack
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1090-1

30 TABLET in 1 BOTTLE (71335-1090-1)
Marketing Start Date2022-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1090-1 [71335109001]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-18

NDC 71335-1090-2 [71335109002]

Cetirizine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077829
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-18

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:ba565ca5-81a7-4655-a693-adb1244c53e7
Manufacturer
UNII

NDC Crossover Matching brand name "Cetirizine Hydrochloride" or generic name "Cetirizine Hydrochloride"

NDCBrand NameGeneric Name
0121-4780Cetirizine HydrochlorideCetirizine Hydrochloride
0179-8301Cetirizine HydrochlorideCetirizine Hydrochloride
0179-8302Cetirizine HydrochlorideCetirizine Hydrochloride
0363-0471Cetirizine HydrochlorideCetirizine Hydrochloride
0363-9899Cetirizine HydrochlorideCetirizine Hydrochloride
0378-3635Cetirizine Hydrochloridecetirizine hydrochloride
67668-161Cetirizine HydrochlorideCetirizine Hydrochloride
67668-162Cetirizine HydrochlorideCetirizine Hydrochloride
68016-353Cetirizine HydrochlorideCetirizine Hydrochloride
68016-939Cetirizine HydrochlorideCetirizine Hydrochloride
68071-1964Cetirizine HydrochlorideCetirizine Hydrochloride
68071-1988Cetirizine HydrochlorideCetirizine Hydrochloride
68151-1008Cetirizine HydrochlorideCetirizine Hydrochloride
68151-3708Cetirizine HydrochlorideCetirizine Hydrochloride
68788-0790Cetirizine HydrochlorideCetirizine Hydrochloride
68788-6905Cetirizine HydrochlorideCetirizine Hydrochloride
68788-9493Cetirizine HydrochlorideCetirizine Hydrochloride
68788-9734Cetirizine HydrochlorideCetirizine Hydrochloride
68788-9985Cetirizine hydrochlorideCetirizine hydrochloride
68998-939Cetirizine HydrochlorideCetirizine Hydrochloride
0536-1041Cetirizine HydrochlorideCetirizine Hydrochloride
0536-4088Cetirizine HydrochlorideCetirizine Hydrochloride
70518-0182Cetirizine HydrochlorideCetirizine Hydrochloride
70518-0664Cetirizine HydrochlorideCetirizine Hydrochloride
70518-0777Cetirizine HydrochlorideCetirizine Hydrochloride
70518-0910Cetirizine HydrochlorideCetirizine Hydrochloride
70518-1989Cetirizine HydrochlorideCetirizine Hydrochloride
70985-002Cetirizine HydrochlorideCetirizine Hydrochloride
71141-133Cetirizine HydrochlorideCetirizine Hydrochloride
70934-199Cetirizine HydrochlorideCetirizine Hydrochloride
71141-000Cetirizine HydrochlorideCetirizine Hydrochloride
71205-164Cetirizine HydrochlorideCetirizine Hydrochloride
70985-001Cetirizine HydrochlorideCetirizine Hydrochloride
71205-207cetirizine hydrochloridecetirizine hydrochloride
71335-0028Cetirizine HydrochlorideCetirizine Hydrochloride
71335-0300Cetirizine HydrochlorideCetirizine Hydrochloride
71205-093Cetirizine HydrochlorideCetirizine Hydrochloride
71335-0755Cetirizine HydrochlorideCetirizine Hydrochloride
71610-048CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE
71610-093Cetirizine HydrochlorideCetirizine Hydrochloride
0615-8240cetirizine hydrochloridecetirizine hydrochloride
0781-1684Cetirizine HydrochlorideCetirizine Hydrochloride
0781-1683Cetirizine HydrochlorideCetirizine Hydrochloride
0781-5284Cetirizine HydrochlorideCetirizine Hydrochloride
0781-5283Cetirizine HydrochlorideCetirizine Hydrochloride
0904-5852Cetirizine HydrochlorideCetirizine Hydrochloride
0904-5879Cetirizine HydrochlorideCetirizine Hydrochloride
0904-6100Cetirizine hydrochlorideCetirizine hydrochloride
10544-670Cetirizine HydrochlorideCetirizine Hydrochloride
12634-987CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.