"71309-005-03" National Drug Code (NDC)

Cetirizine Hydrochloride 300 TABLET, COATED in 1 BOTTLE (71309-005-03)
(Safrel Pharmaceuticals, LLC)

NDC Code71309-005-03
Package Description300 TABLET, COATED in 1 BOTTLE (71309-005-03)
Product NDC71309-005
Product Type NameHUMAN OTC DRUG
Proprietary NameCetirizine Hydrochloride
Non-Proprietary NameCetirizine Hydrochloride
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20180528
Marketing Category NameANDA
Application NumberANDA209274
ManufacturerSafrel Pharmaceuticals, LLC
Substance NameCETIRIZINE HYDROCHLORIDE
Strength10
Strength Unitmg/1
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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