"80513-731-12" National Drug Code (NDC)

Cetirizine Hydrochloride 120 TABLET, COATED in 1 BOTTLE (80513-731-12)
(Advanced Rx LLC)

NDC Code80513-731-12
Package Description120 TABLET, COATED in 1 BOTTLE (80513-731-12)
Product NDC80513-731
Product Type NameHUMAN OTC DRUG
Proprietary NameCetirizine Hydrochloride
Non-Proprietary NameCetirizine Hydrochloride
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20250501
Marketing Category NameANDA
Application NumberANDA209274
ManufacturerAdvanced Rx LLC
Substance NameCETIRIZINE HYDROCHLORIDE
Strength10
Strength Unitmg/1
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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