NDC 0904-6717

Cetirizine

Cetirizine Hydrochloride

Cetirizine is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Cetirizine Hydrochloride.

Product ID0904-6717_06390749-5795-4e50-94bd-acb4b96e4b83
NDC0904-6717
Product TypeHuman Otc Drug
Proprietary NameCetirizine
Generic NameCetirizine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA078336
Labeler NameMajor Pharmaceuticals
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6717-61

100 BLISTER PACK in 1 CARTON (0904-6717-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6717-60 [00904671760]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-86 [00904671786]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-40 [00904671740]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-72 [00904671772]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-46 [00904671746]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-61 [00904671761]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-06-29

NDC 0904-6717-43 [00904671743]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-07-03

NDC 0904-6717-41 [00904671741]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-06-29

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014678

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

    NDCBrand NameGeneric Name
    0363-1040CetirizineCetirizine
    70518-1705CetirizineCetirizine
    70518-1652CetirizineCetirizine
    71610-123CetirizineCetirizine
    0615-7522CetirizineCetirizine
    75921-402CetirizineCetirizine
    0904-6717CetirizineCetirizine
    11673-219CetirizineCetirizine
    21695-878CetirizineCetirizine
    60505-4668CetirizineCetirizine
    60505-4322CetirizineCetirizine
    63629-3708CetirizineCetirizine
    67046-680CetirizineCetirizine
    55154-8081CetirizineCetirizine
    60505-4706CetirizineCetirizine
    70518-2335CetirizineCetirizine
    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
    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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