NDC 50458-028

Spravato

Esketamine Hydrochloride

Spravato is a Nasal Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals Inc.. The primary component is Esketamine Hydrochloride.

Product ID50458-028_1dba1990-67e5-11e9-bfa1-bcc20099106d
NDC50458-028
Product TypeHuman Prescription Drug
Proprietary NameSpravato
Generic NameEsketamine Hydrochloride
Dosage FormSolution
Route of AdministrationNASAL
Marketing Start Date2019-03-05
Marketing CategoryNDA / NDA
Application NumberNDA211243
Labeler NameJanssen Pharmaceuticals Inc.
Substance NameESKETAMINE HYDROCHLORIDE
Active Ingredient Strength28 mg/.2mL
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-028-02

2 BLISTER PACK in 1 KIT (50458-028-02) > 1 VIAL, SINGLE-USE in 1 BLISTER PACK > .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
Marketing Start Date2019-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-028-00 [50458002800]

Spravato SOLUTION
Marketing CategoryNDA
Application NumberNDA211243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-05

NDC 50458-028-02 [50458002802]

Spravato SOLUTION
Marketing CategoryNDA
Application NumberNDA211243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-05

NDC 50458-028-03 [50458002803]

Spravato SOLUTION
Marketing CategoryNDA
Application NumberNDA211243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-05

Drug Details

Active Ingredients

IngredientStrength
ESKETAMINE HYDROCHLORIDE28 mg/.2mL

OpenFDA Data

SPL SET ID:d81a6a79-a74a-44b7-822c-0dfa3036eaed
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2119390
  • 2119391
  • 2119381
  • 2119387
  • 2119389
  • 2119388

  • Trademark Results [Spravato]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SPRAVATO
    SPRAVATO
    87192311 5807268 Live/Registered
    JOHNSON & JOHNSON
    2016-10-04

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