"49483-692-65" National Drug Code (NDC)

Cetirizine Hydrochloride Tablets,10 Mg 365 TABLET in 1 BOTTLE (49483-692-65)
(TIME CAP LABORATORIES, INC.)

NDC Code49483-692-65
Package Description365 TABLET in 1 BOTTLE (49483-692-65)
Product NDC49483-692
Product Type NameHUMAN OTC DRUG
Proprietary NameCetirizine Hydrochloride Tablets,10 Mg
Non-Proprietary NameCetirizine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20220212
Marketing Category NameANDA
Application NumberANDA078933
ManufacturerTIME CAP LABORATORIES, INC.
Substance NameCETIRIZINE HYDROCHLORIDE
Strength10
Strength Unitmg/1
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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