83114-101 : Xcopri Maintenance Pack 100 mg, 150 mg 150 mg/1501 Oral Tablet, Film Coated

NDC:	83114-101
Labeler:	Pci Pharma Services Canada, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Xcopri Maintenance Pack 100 mg, 150 mg
Dosage Form:	Oral Tablet, Film Coated
Application #:	NDA212839
Rev. Date:	Mar 12, 2020
CSA Schedule:	CV (US) [1]

^[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 83114-101-56: 1 TABLET, FILM COATED IN 1 BLISTER PACK (83114‑101‑56)

Active Ingredients:

• Cenobamate

Pharmaceutical Classes:

• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2B6 Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 2C8 Inducers [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• GABA A Receptor Positive Modulators [MoA]
• Sodium Channel Antagonists [MoA]

Related Products:

Based on records with the same trade name.

• 83114-104 Xcopri Maintenance Pack 100 mg, 150 mg 100 mg/1001 Oral Tablet, Film Coated by Pci Pharma Services Canada, Inc.

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