"49483-682-01" National Drug Code (NDC)

Cetirizine Hydrochloride 100 TABLET in 1 BOTTLE (49483-682-01)
(TIME CAP LABORATORIES, INC.)

NDC Code49483-682-01
Package Description100 TABLET in 1 BOTTLE (49483-682-01)
Product NDC49483-682
Product Type NameHUMAN OTC DRUG
Proprietary NameCetirizine Hydrochloride
Non-Proprietary NameCetirizine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20220530
Marketing Category NameANDA
Application NumberANDA078933
ManufacturerTIME CAP LABORATORIES, INC.
Substance NameCETIRIZINE HYDROCHLORIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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