Metaxalone

Product NDC
68084-135
11-digit product format
680840135
Labeler code
68084
Product ID
68084-135_ea3f4d52-0159-e0be-e053-2995a90a1325
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203399
Marketing category
ANDA
Marketing start
2013-12-09
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
68084-135-11EA - Each68084-1354a4fc33a-5b63-4047-af2f-1a503400e69112014-01-04
68084-135-21EA - Each68084-1352e9b1a51-2108-4152-9cf4-c6704ce8e41312014-01-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-135-216808401352130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-135-21) > 1 TABLET in 1 BLISTER PACK (68084-135-11) 30 blister pack2013-12-090000-00-00NoNoCurrent