Rilutek

Product NDC: 70515-700
11-digit product format: 705150700
Labeler code: 70515
Product ID: 70515-700_6f43fef8-e4d9-4552-81f5-f6fd7f961de0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: riluzole
Dosage form: TABLET
Route: ORAL
Labeler: Covis Pharma US, Inc
Application: NDA020599
Marketing category: NDA
Marketing start: 2016-08-01
Marketing end: 0000-00-00
Substance: RILUZOLE
Active strength: 50 mg/1
Pharmacologic classes: Benzothiazole [EPC], Benzothiazoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70515-700-60	2022-12-14	C162847	48780-1	e4f33bdf-a69d-d8a0-e053-dadaa90a6e4e	6ddc26d7-a6fe-46dd-8b49-c55aa111f83e
70515-700-60	2022-07-29	C162847	48780-1	e4f33bdf-a69d-d8a0-e053-dadaa90a6e4e	6ddc26d7-a6fe-46dd-8b49-c55aa111f83e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-700-60	EA - Each	70515-700	00e8da8d-49c6-472d-a294-53d20e475fda	1	2016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70515-700-60	70515070060	1 BOTTLE in 1 CARTON (70515-700-60) > 60 TABLET in 1 BOTTLE	1 bottle	2016-08-01	0000-00-00	No	No	Current