NDC 68094-004

Dye Free Childrens Cetirizine Hydrocholride

Cetirizine Hydrochloride

Dye Free Childrens Cetirizine Hydrocholride is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Cetirizine Hydrochloride.

Product ID68094-004_ad976192-fd11-49d6-84f5-b619a78ef3ab
NDC68094-004
Product TypeHuman Otc Drug
Proprietary NameDye Free Childrens Cetirizine Hydrocholride
Generic NameCetirizine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA204226
Labeler NamePrecision Dose, Inc.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68094-004-62

3 TRAY in 1 CASE (68094-004-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)
Marketing Start Date2016-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-004-62 [68094000462]

Dye Free Childrens Cetirizine Hydrocholride SOLUTION
Marketing CategoryANDA
Application NumberANDA204226
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-10-26

NDC 68094-004-59 [68094000459]

Dye Free Childrens Cetirizine Hydrocholride SOLUTION
Marketing CategoryANDA
Application NumberANDA204226
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-10-26

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:6a7c4dff-66c6-4d0c-af10-d908c65a43be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014673

    • NDC Crossover Matching brand name "Dye Free Childrens Cetirizine Hydrocholride" or generic name "Cetirizine Hydrochloride"

    NDCBrand NameGeneric Name
    68094-004Dye Free Childrens Cetirizine HydrocholrideDye Free Childrens Cetirizine Hydrocholride
    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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