50458-028 : Spravato 28 mg/.2ml Nasal Solution


NDC: 50458-028
Labeler: Janssen Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Spravato
Dosage Form: Nasal Solution
Application #: NDA211243
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 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)
  • 50458-028-03: 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)

Active Ingredients:

  • Esketamine Hydrochloride

Dosage Strength:

  • 28 mg/.2mL

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.