Metaxalone

Product NDC
42291-587
11-digit product format
422910587
Labeler code
42291
Product ID
42291-587_d57df893-46e9-5689-e053-2995a90a42a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA203399
Marketing category
ANDA
Marketing start
2015-05-22
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-587-01EA - Each42291-5873d6fd381-6202-424f-bf84-6fbb063134cb12015-07-20
42291-587-50EA - Each42291-5875397d62f-71fd-4a4d-8fba-a52ec52a767312016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-587-0142291058701100 TABLET in 1 BOTTLE (42291-587-01) 100 tablet2015-05-220000-00-00NoNoCurrent
42291-587-5042291058750500 TABLET in 1 BOTTLE (42291-587-50) 500 tablet2016-06-220000-00-00NoNoCurrent