NDC 65162-145

Cetirizine Hydrochloride Hives Relief

Cetirizine

Cetirizine Hydrochloride Hives Relief is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals. The primary component is Cetirizine Hydrochloride.

Product ID65162-145_be2bac86-6f22-471d-a517-c7b7a6e5995b
NDC65162-145
Product TypeHuman Otc Drug
Proprietary NameCetirizine Hydrochloride Hives Relief
Generic NameCetirizine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-01-21
Marketing CategoryANDA / ANDA
Application NumberANDA078780
Labeler NameAmneal Pharmaceuticals
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 65162-145-03

1 BOTTLE in 1 CARTON (65162-145-03) > 30 TABLET in 1 BOTTLE
Marketing Start Date2010-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-145-03 [65162014503]

Cetirizine Hydrochloride Hives Relief TABLET
Marketing CategoryANDA
Application NumberANDA078780
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-21
Inactivation Date2020-01-31

NDC 65162-145-50 [65162014550]

Cetirizine Hydrochloride Hives Relief TABLET
Marketing CategoryANDA
Application NumberANDA078780
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:aad39214-5bf1-427b-a00e-410224c51c95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014676
  • NDC Crossover Matching brand name "Cetirizine Hydrochloride Hives Relief" or generic name "Cetirizine"

    NDCBrand NameGeneric Name
    51824-076CAREALL Cetirizine HClCetirizine
    0363-1040CetirizineCetirizine
    11673-219CetirizineCetirizine
    21695-878CetirizineCetirizine
    60505-4322CetirizineCetirizine
    60505-4668CetirizineCetirizine
    60505-4706CetirizineCetirizine
    67046-680CetirizineCetirizine
    37012-939Cetirizine HydrochlorideCetirizine
    65162-003Cetirizine HydrochlorideCetirizine
    65162-005Cetirizine HydrochlorideCetirizine
    65162-045Cetirizine HydrochlorideCetirizine
    65162-046Cetirizine HydrochlorideCetirizine
    65162-145Cetirizine HydrochlorideCetirizine
    65162-146Cetirizine HydrochlorideCetirizine
    65162-684Cetirizine HydrochlorideCetirizine
    37205-820LEADER ALL DAY ALLERGYcetirizine
    71776-024ZerviateCetirizine

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