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Xcopri

cenobamate · Kit

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Xcopri Titration Pack
Generic name
cenobamate
Dosage form
Kit
Route
Oral
Marketing category
NDA · NDA
Labeler
SK Life Science, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
5
Packages
5
Data completeness
60% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
Oral
Presentations
10

Regulatory status

Source: Drugs@FDANDC Directory
Application number
212839
Application type
NDA · New Drug Application
Approval date
November 21, 2019
Sponsor
SK LIFE
Products on application
6
Submissions recorded
8
Products approved under application 212839.
Product Trade name Form Strength Ingredient Status TE Flags
212839-001 XCOPRI TABLET CENOBAMATE Prescription — RLD RS
212839-002 XCOPRI TABLET CENOBAMATE Prescription — RLD
212839-003 XCOPRI TABLET CENOBAMATE Prescription — RLD
212839-004 XCOPRI TABLET CENOBAMATE Prescription — RLD
212839-005 XCOPRI TABLET CENOBAMATE Prescription — RLD
212839-006 XCOPRI TABLET CENOBAMATE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7598279 October 30, 2032 001 Yes March 12, 2020
7598279 October 30, 2032 002 Yes March 12, 2020
7598279 October 30, 2032 003 Yes March 12, 2020
7598279 October 30, 2032 004 Yes March 12, 2020
7598279 October 30, 2032 005 Yes March 12, 2020
7598279 October 30, 2032 006 Yes March 12, 2020
11654133 June 16, 2039 001 No U-3610 May 31, 2023
11654133 June 16, 2039 002 No U-3610 May 31, 2023
11654133 June 16, 2039 003 No U-3610 May 31, 2023
11654133 June 16, 2039 004 No U-3610 May 31, 2023
11654133 June 16, 2039 005 No U-3610 May 31, 2023
11654133 June 16, 2039 006 No U-3610 May 31, 2023

Approval history

Source: Drugs@FDA
Most recent submissions on application 212839.
Type No. Action Status Date Review
Supplement 13 Labeling Approved August 18, 2025 Standard
Supplement 10 Labeling Approved April 5, 2024 Standard
Supplement 9 Labeling Approved April 5, 2024 Standard
Supplement 8 Labeling Approved January 26, 2024 Standard
Supplement 7 Labeling Approved June 27, 2022 Standard
Supplement 6 Labeling Approved June 27, 2022 Standard
Supplement 1 Labeling Approved August 31, 2020 Standard
Original application 1 Type 1 - New Molecular Entity Approved November 21, 2019 Standard

Review documents

  • 0 · Supplement · August 20, 2025
  • 0 · Supplement · August 20, 2025
  • 0 · Supplement · August 19, 2025
  • 0 · Supplement · April 9, 2024
  • 0 · Supplement · April 9, 2024
  • 0 · Supplement · April 9, 2024
  • 0 · Supplement · April 8, 2024
  • 0 · Supplement · April 8, 2024
  • 0 · Supplement · January 29, 2024
  • 0 · Supplement · January 29, 2024
  • 0 · Supplement · June 30, 2022
  • 0 · Supplement · June 30, 2022
  • 0 · Supplement · June 28, 2022
  • 0 · Supplement · June 28, 2022
  • 0 · Original application · October 8, 2021
  • 0 · Supplement · September 4, 2020
  • 0 · Supplement · September 1, 2020
  • 0 · Original application · December 10, 2019
  • 0 · Original application · November 22, 2019
  • 0 · Original application · November 22, 2019

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
71699-103-56 71699-103 SK Life Science, Inc. 1 KIT in 1 CARTON (71699-103-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK March 12, 2020
71699-104-56 71699-104 SK Life Science, Inc. 1 KIT in 1 CARTON (71699-104-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK April 30, 2021
71699-201-28 71699-201 SK Life Science, Inc. 1 KIT in 1 CARTON (71699-201-28) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK March 12, 2020
71699-202-28 71699-202 SK Life Science, Inc. 1 KIT in 1 CARTON (71699-202-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK March 12, 2020
71699-203-28 71699-203 SK Life Science, Inc. 1 KIT in 1 CARTON (71699-203-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK March 12, 2020
71699-103 71699-103 SK Life Science, Inc. — March 12, 2020
71699-104 71699-104 SK Life Science, Inc. — April 30, 2021
71699-201 71699-201 SK Life Science, Inc. — March 12, 2020
71699-202 71699-202 SK Life Science, Inc. — March 12, 2020
71699-203 71699-203 SK Life Science, Inc. — March 12, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.