"50458-028-03" National Drug Code (NDC)

Spravato 3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
(Janssen Pharmaceuticals Inc.)

NDC Code50458-028-03
Package Description3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
Product NDC50458-028
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSpravato
Non-Proprietary NameEsketamine Hydrochloride
Dosage FormSOLUTION
UsageNASAL
Start Marketing Date20190305
Marketing Category NameNDA
Application NumberNDA211243
ManufacturerJanssen Pharmaceuticals Inc.
Substance NameESKETAMINE HYDROCHLORIDE
Strength28
Strength Unitmg/.2mL
DEA ScheduleCIII

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