METAXALONE

Product NDC
50742-277
11-digit product format
507420277
Labeler code
50742
Product ID
50742-277_401b0712-b041-489a-addb-a34515ef9026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA213836
Marketing category
ANDA
Marketing start
2020-10-21
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-277-0150742027701100 TABLET in 1 BOTTLE (50742-277-01) 100 tablet2020-10-210000-00-00NoNoCurrent
50742-277-0550742027705500 TABLET in 1 BOTTLE (50742-277-05) 500 tablet2020-10-210000-00-00NoNoCurrent