Xcopri

Product NDC: 71699-102
11-digit product format: 716990102
Labeler code: 71699
Product ID: 71699-102_b8c112f3-da21-419e-8ea1-c5d231f15d3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cenobamate
Dosage form: KIT
Route: ORAL
Labeler: SK Life Science, Inc.
Application: NDA212839
Marketing category: NDA
Marketing start: 2020-03-12
Marketing end: 2022-10-31
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71699-102-56	2020-07-22	C162847	48780-1	ab0e2407-2777-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use XCOPRI safely and effectively. See full prescribing information for XCOPRI. XCOPRI ® (cenobamate tablets), for oral use, CV Initial U.S. Approval: 2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71699-102-56	EA - Each	71699-102	1ae273f9-72bf-4dfe-b912-ac7875d44ac0	1	2020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71699-102-56	71699010256	1 KIT in 1 CARTON (71699-102-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2020-03-12	0000-00-00	No	No	Current