NDC 16853-1305

ALLEROFF

Cetirizine Hydrochloride

ALLEROFF is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Corporacion Infarmasa. The primary component is Cetirizine Hydrochloride.

Product ID16853-1305_98661a3c-c95c-4ab1-b62f-87dde7f88296
NDC16853-1305
Product TypeHuman Otc Drug
Proprietary NameALLEROFF
Generic NameCetirizine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-01-01
Marketing CategoryNDA / NDA
Application NumberNDA019835
Labeler NameCorporacion Infarmasa
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 16853-1305-3

2 TABLET in 1 BLISTER PACK (16853-1305-3)
Marketing Start Date2010-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16853-1305-3 [16853130503]

ALLEROFF TABLET
Marketing CategoryNDA
Application NumberNDA019835
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-01
Inactivation Date2019-10-21

NDC 16853-1305-2 [16853130502]

ALLEROFF TABLET
Marketing CategoryNDA
Application NumberNDA019835
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-01
Inactivation Date2019-10-21

NDC 16853-1305-1 [16853130501]

ALLEROFF TABLET
Marketing CategoryNDA
Application NumberNDA019835
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-01

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:2e431020-bf57-46a7-bbfd-487b87d00ffb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020025
  • 1014678

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

    NDCBrand NameGeneric Name
    16853-1261ALLEROFFALLEROFF
    16853-1305ALLEROFFALLEROFF
    16853-1307ALLEROFFALLEROFF
    0363-4101allergy reliefCetirizine Hydrochloride
    0113-7002Basic Care All Day AllergyCetirizine Hydrochloride
    0113-7036BASIC CARE ALL DAY ALLERGYCetirizine hydrochloride
    0121-4780Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8301Cetirizine HydrochlorideCetirizine Hydrochloride
    0179-8302Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-0471Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-9899Cetirizine HydrochlorideCetirizine Hydrochloride
    0378-3635Cetirizine Hydrochloridecetirizine hydrochloride
    0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride
    0363-9602Cetirizine Hydrochloride (Allergy)Cetirizine Hydrochloride
    0363-3311childrens allergy reliefCetirizine Hydrochloride
    0363-3393childrens allergy reliefCetirizine Hydrochloride
    0363-4025Childrens Cetirizine HydrochlorideCetirizine Hydrochloride
    0363-1884childrens dye free wal zyrcetirizine Hydrochloride
    0363-0595Childrens Wal Zyr 24 Hour Allergycetirizine Hydrochloride
    0363-0974Childrens Wal Zyr Allergycetirizine hydrochloride
    0363-1974dye free wal zyrcetirizine hydrochloride
    0113-0981Good Sense All Day Allergycetirizine hydrochloride
    0113-1036good sense all day allergyCetirizine hydrochloride
    0113-9458Good Sense all day allergyCetirizine Hydrochloride
    0363-0276wal zyrCetirizine Hydrochloride
    0363-0495Wal ZyrCetirizine Hydrochloride
    0363-2088Wal-ZyrCetirizine Hydrochloride
    0363-2102Wal-ZyrCetirizine Hydrochloride
    0363-2106Wal-ZyrCetirizine Hydrochloride

    Trademark Results [ALLEROFF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALLEROFF
    ALLEROFF
    77745548 not registered Dead/Abandoned
    CORPORACION INFARMASA S.A.
    2009-05-27
    © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.