"70529-007-01" National Drug Code (NDC)

Durapren 0.75% 1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-007-01) > 30 mL in 1 VIAL, SINGLE-DOSE
(IT3 Medical LLC)

NDC Code70529-007-01
Package Description1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-007-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Product NDC70529-007
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDurapren 0.75%
Non-Proprietary NameBupivacaine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageEPIDURAL; RETROBULBAR
Start Marketing Date20170301
Marketing Category NameNDA
Application NumberNDA016964
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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