"0591-0607-01" National Drug Code (NDC)

Labetalol Hydrochloride 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-01)
(Actavis Pharma, Inc.)

NDC Code0591-0607-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-01)
Product NDC0591-0607
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLabetalol Hydrochloride
Non-Proprietary NameLabetalol Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date19980803
Marketing Category NameANDA
Application NumberANDA075133
ManufacturerActavis Pharma, Inc.
Substance NameLABETALOL HYDROCHLORIDE
Strength300
Strength Unitmg/1
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]

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