Metaxalone

Product NDC
68001-004
11-digit product format
680010004
Labeler code
68001
Product ID
68001-004_e1003130-b775-e738-e053-2a95a90a18b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA203399
Marketing category
ANDA
Marketing start
2014-04-22
Marketing end
2023-07-31
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-004-00EA - Each68001-004c7e56100-764d-4b3e-ade0-287749b9658112013-11-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-004-0068001000400100 TABLET in 1 BOTTLE (68001-004-00) 100 tablet2014-04-220000-00-00NoNoCurrent