"70529-008-01" National Drug Code (NDC)

Burapren 0.75% 1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE
(IT3 Medical LLC)

NDC Code70529-008-01
Package Description1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Product NDC70529-008
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBurapren 0.75%
Non-Proprietary NameBupivacaine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageEPIDURAL; RETROBULBAR
Start Marketing Date20170301
Marketing Category NameANDA
Application NumberANDA203895
ManufacturerIT3 Medical LLC
Substance NameBUPIVACAINE HYDROCHLORIDE
Strength7.5
Strength Unitmg/mL
Pharmacy ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]

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