NDC 50580-778

Zyrtec Allergy

Cetirizine Hydrochloride

Zyrtec Allergy is a Oral Tablet, Orally Disintegrating in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Cetirizine Hydrochloride.

Product ID50580-778_3a640dce-3522-4db5-95d3-37ddd7c6697f
NDC50580-778
Product TypeHuman Otc Drug
Proprietary NameZyrtec Allergy
Generic NameCetirizine Hydrochloride
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2014-01-20
Marketing CategoryNDA / NDA
Application NumberNDA022578
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50580-778-24

4 BLISTER PACK in 1 CARTON (50580-778-24) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2014-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-778-66 [50580077866]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-20
Marketing End Date2017-03-31

NDC 50580-778-06 [50580077806]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-20
Marketing End Date2014-01-07

NDC 50580-778-12 [50580077812]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-01-20
Marketing End Date2017-04-30

NDC 50580-778-24 [50580077824]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-01-20

NDC 50580-778-40 [50580077840]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-20
Marketing End Date2013-05-21

NDC 50580-778-41 [50580077841]

Zyrtec Allergy TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022578
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-20
Marketing End Date2013-05-21

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:6a962a1c-c197-492b-bfa6-e0c28eda1533
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011482
  • 1011485
  • NDC Crossover Matching brand name "Zyrtec Allergy" or generic name "Cetirizine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-726Zyrtec AllergyZyrtec Allergy
    50580-778Zyrtec AllergyZyrtec Allergy
    67751-192Zyrtec AllergyZyrtec Allergy
    50580-752Zyrtec AllergyZyrtec Allergy
    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

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