"0378-3635-01" National Drug Code (NDC)

Cetirizine Hydrochloride 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3635-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01)
Product NDC0378-3635
Product Type NameHUMAN OTC DRUG
Proprietary NameCetirizine Hydrochloride
Non-Proprietary NameCetirizine Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20071227
Marketing Category NameANDA
Application NumberANDA076677
ManufacturerMylan Pharmaceuticals Inc.
Substance NameCETIRIZINE HYDROCHLORIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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