Metaxalone

Product NDC
63629-2398
11-digit product format
636292398
Labeler code
63629
Product ID
63629-2398_51e56f06-04f9-494f-a10b-23c43c917147
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208774
Marketing category
ANDA
Marketing start
2018-09-24
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
63629-2398-1EA - Each63629-2398523ecbec-484c-4582-9f61-b61037361ed112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2398METAXALONE TABLET [BRYANT RANCH PREPACK]102Legacy NDC20231209_4b81747c-1482-48cf-b8be-9aac6c44215e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2398-163629239801100 TABLET in 1 BOTTLE (63629-2398-1) 100 tablet2021-02-230000-00-00NoNoCurrent