NDC 70518-1705

Cetirizine

Cetirizine Hydrochloride

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

Product ID70518-1705_7c399ca0-d3a0-ed97-e053-2991aa0ab3f4
NDC70518-1705
Product TypeHuman Otc Drug
Proprietary NameCetirizine
Generic NameCetirizine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA078336
Labeler NameREMEDYREPACK INC.
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1705-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1705-0)
Marketing Start Date2018-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1705-1 [70518170501]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-30

NDC 70518-1705-2 [70518170502]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-16

NDC 70518-1705-0 [70518170500]

Cetirizine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078336
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-03

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:9b7d9bf9-29bd-4e33-933d-9cb8fd4cf778
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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