"52584-083-61" National Drug Code (NDC)

Nalbuphine Hydrochloride 1 VIAL, MULTI-DOSE in 1 BAG (52584-083-61) > 10 mL in 1 VIAL, MULTI-DOSE
(General Injectables and Vaccines,Inc.)

NDC Code52584-083-61
Package Description1 VIAL, MULTI-DOSE in 1 BAG (52584-083-61) > 10 mL in 1 VIAL, MULTI-DOSE
Product NDC52584-083
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNalbuphine Hydrochloride
Non-Proprietary NameNalbuphine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Start Marketing Date20210419
Marketing Category NameANDA
Application NumberANDA070918
ManufacturerGeneral Injectables and Vaccines,Inc.
Substance NameNALBUPHINE HYDROCHLORIDE
Strength20
Strength Unitmg/mL
Pharmacy ClassesCompetitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]

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