"83301-0059-1" National Drug Code (NDC)

Labetalol Hydrochloride 1 VIAL, MULTI-DOSE in 1 CARTON (83301-0059-1) / 40 mL in 1 VIAL, MULTI-DOSE
(Mullan Pharmaceutical Inc.)

NDC Code83301-0059-1
Package Description1 VIAL, MULTI-DOSE in 1 CARTON (83301-0059-1) / 40 mL in 1 VIAL, MULTI-DOSE
Product NDC83301-0059
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLabetalol Hydrochloride
Non-Proprietary NameLabetalol Hydrochloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20251205
Marketing Category NameANDA
Application NumberANDA090699
ManufacturerMullan Pharmaceutical Inc.
Substance NameLABETALOL HYDROCHLORIDE
Strength200
Strength Unitmg/40mL
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]

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