"83270-178-01" National Drug Code (NDC)

Labetalol Hydrochloride 1 VIAL, MULTI-DOSE in 1 CARTON (83270-178-01) / 20 mL in 1 VIAL, MULTI-DOSE
(Onesource Specialty Pharma Limited)

NDC Code83270-178-01
Package Description1 VIAL, MULTI-DOSE in 1 CARTON (83270-178-01) / 20 mL in 1 VIAL, MULTI-DOSE
Product NDC83270-178
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLabetalol Hydrochloride
Non-Proprietary NameLabetalol Hydrochloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20260227
Marketing Category NameANDA
Application NumberANDA079134
ManufacturerOnesource Specialty Pharma Limited
Substance NameLABETALOL HYDROCHLORIDE
Strength5
Strength Unitmg/mL
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]

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