NDC 62135-057

Cetirizine Hydrochloride Oral Solution

Cetirizine Hydrochloride Oral Solution

Cetirizine Hydrochloride Oral Solution is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Chartwell Rx, Llc. The primary component is Cetirizine Hydrochloride.

Product ID62135-057_e2886dca-2a46-d71e-e053-2995a90a9345
NDC62135-057
Product TypeHuman Prescription Drug
Proprietary NameCetirizine Hydrochloride Oral Solution
Generic NameCetirizine Hydrochloride Oral Solution
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2012-05-11
Marketing CategoryANDA /
Application NumberANDA078876
Labeler NameChartwell RX, LLC
Substance NameCETIRIZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 62135-057-41

120 mL in 1 BOTTLE (62135-057-41)
Marketing Start Date2022-06-08
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Cetirizine Hydrochloride Oral Solution" or generic name "Cetirizine Hydrochloride Oral Solution"

NDCBrand NameGeneric Name
13668-029Cetirizine Hydrochloride Oral SolutionCetirizine Hydrochloride Oral Solution
62135-057Cetirizine Hydrochloride Oral SolutionCetirizine Hydrochloride Oral Solution

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.