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 ID: 50458-028_1dba1990-67e5-11e9-bfa1-bcc20099106d
• NDC: 50458-028
• Product Type: Human Prescription Drug
• Proprietary Name: Spravato
• Generic Name: Esketamine Hydrochloride
• Dosage Form: Solution
• Route of Administration: NASAL
• Marketing Start Date: 2019-03-05
• Marketing Category: NDA / NDA
• Application Number: NDA211243
• Labeler Name: Janssen Pharmaceuticals Inc.
• Substance Name: ESKETAMINE HYDROCHLORIDE
• Active Ingredient Strength: 28 mg/.2mL
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2019-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-028-00 [50458002800]

Spravato SOLUTION

• Marketing Category: NDA
• Application Number: NDA211243
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-05

NDC 50458-028-02 [50458002802]

Spravato SOLUTION

• Marketing Category: NDA
• Application Number: NDA211243
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-05

NDC 50458-028-03 [50458002803]

Spravato SOLUTION

• Marketing Category: NDA
• Application Number: NDA211243
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-05

Drug Details

Active Ingredients

Ingredient	Strength
ESKETAMINE HYDROCHLORIDE	28 mg/.2mL

OpenFDA Data

• SPL SET ID: d81a6a79-a74a-44b7-822c-0dfa3036eaed
• Manufacturer:
  • Janssen Pharmaceuticals Inc.
• UNII:
  • L8P1H35P2Z
• RxNorm Concept Unique ID - RxCUI:
  • 2119390
  • 2119391
  • 2119381
  • 2119387
  • 2119389
  • 2119388