Myambutol

Product NDC: 68850-010
11-digit product format: 688500010
Labeler code: 68850
Product ID: 68850-010_d811b183-f875-3ea9-e053-2995a90af90f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethambutol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: STI Pharma, LLC
Application: NDA016320
Marketing category: NDA
Marketing start: 2007-08-10
Marketing end: 0000-00-00
Substance: ETHAMBUTOL HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
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
68850-010-01	2020-03-03	C162847	48780-1	9d75b9d0-19de-f424-e053-dadaa90a57ce	b362b3cd-2c26-4af5-baa4-084217729fa5
68850-010-01	2020-01-31	C162847	48780-1	9d75b9d0-19de-f424-e053-dadaa90a57ce	b362b3cd-2c26-4af5-baa4-084217729fa5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68850-010-01	EA - Each	68850-010	18dab2d0-4734-4706-afdc-fff4c6742fd7	1	2013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68850-010-01	68850001001	100 TABLET, FILM COATED in 1 BOTTLE (68850-010-01)	2007-08-10	0000-00-00	No	No	Current