69616-282 : Fycompa 12 mg Oral Tablet


NDC: 69616-282
Labeler: Catalyst Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fycompa
Dosage Form: Oral Tablet
Application #: NDA202834
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:

  • 69616-282-30: 30 TABLET IN 1 BOTTLE (69616‑282‑30)
  • 69616-282-90: 90 TABLET IN 1 BOTTLE (69616‑282‑90)

Active Ingredients:

  • Perampanel

Dosage Strength:

  • 12 mg

Pharmaceutical Classes:

  • AMPA Receptor Antagonists [MoA]
  • Cytochrome P450 2C8 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Noncompetitive AMPA Glutamate Receptor Antagonist [EPC]
  • UGT1A9 Inhibitors [MoA]
  • UGT2B7 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 69616-272 Fycompa 2 mg Oral Tablet by Catalyst Pharmaceuticals, Inc.
  • 69616-274 Fycompa 4 mg Oral Tablet by Catalyst Pharmaceuticals, Inc.
  • 69616-276 Fycompa 6 mg Oral Tablet by Catalyst Pharmaceuticals, Inc.
  • 69616-278 Fycompa 8 mg Oral Tablet by Catalyst Pharmaceuticals, Inc.
  • 69616-280 Fycompa 10 mg Oral Tablet by Catalyst Pharmaceuticals, Inc.
  • 69616-290 Fycompa .5 mg/ml Oral Suspension by Catalyst Pharmaceuticals, Inc.
  • 62856-270 Fycompa 2-week Sample Pack Kit by Eisai Inc.
  • 62856-272 Fycompa 2 mg Oral Tablet by Eisai Inc.
  • 62856-274 Fycompa 4 mg Oral Tablet by Eisai Inc.
  • 62856-276 Fycompa 6 mg Oral Tablet by Eisai Inc.
  • 62856-278 Fycompa 8 mg Oral Tablet by Eisai Inc.
  • 62856-280 Fycompa 10 mg Oral Tablet by Eisai Inc.
  • 62856-282 Fycompa 12 mg Oral Tablet by Eisai Inc.
  • 62856-290 Fycompa .5 mg/ml Oral Suspension by Eisai Inc.

NDC QR Code

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Related Discussions:

Seems Fycompa is causing more seizures.
My daughter is now on five different anti epileptics, last one added was Fycompa and everything has gotten worse. Many m... 1 reply




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