NDC 57664-263

CETIRIZINE HYDROLORIDE Allergy

Cetirizine Hydroloride

CETIRIZINE HYDROLORIDE Allergy is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Caraco Pharmaceutical Laboratories, Ltd. The primary component is Cetirizine Hydrochloride.

Product ID57664-263_60c4d8e0-3578-4ad3-aaad-272d1c1b5afd
NDC57664-263
Product TypeHuman Otc Drug
Proprietary NameCETIRIZINE HYDROLORIDE Allergy
Generic NameCetirizine Hydroloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA091327
Labeler NameCaraco Pharmaceutical Laboratories, Ltd
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57664-263-31

120 mL in 1 BOTTLE (57664-263-31)
Marketing Start Date2011-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-263-31 [57664026331]

CETIRIZINE HYDROLORIDE Allergy SOLUTION
Marketing CategoryANDA
Application NumberANDA091327
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-01
Inactivation Date2019-11-13

NDC 57664-263-34 [57664026334]

CETIRIZINE HYDROLORIDE Allergy SOLUTION
Marketing CategoryANDA
Application NumberANDA091327
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:60c4d8e0-3578-4ad3-aaad-272d1c1b5afd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014673
  • UPC Code
  • 0357664263310

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