Riluzole

Product NDC: 64980-191
11-digit product format: 649800191
Labeler code: 64980
Product ID: 64980-191_2b3b7f81-bc9f-4d9e-94c4-ab59df1db5a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: riluzole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: NDA020599
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-05-15
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: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64980-191-06	2024-03-12	C162847	48780-1	d6a99b39-695b-a426-e053-dadaa90af4c2	f3c2360d-cec4-4a4a-83b6-35e0114d2bc3
64980-191-06	2022-01-28	C162847	48780-1	d6a99b39-695b-a426-e053-dadaa90af4c2	f3c2360d-cec4-4a4a-83b6-35e0114d2bc3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-191-06	EA - Each	64980-191	b20ab052-451b-4c15-b84b-f0da9d4147b6	1	2013-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-191-06	64980019106	60 TABLET, FILM COATED in 1 BOTTLE (64980-191-06)	2013-05-15	0000-00-00	No	No	Current