Metaxalone

Product NDC
0115-1748
11-digit product format
001151748
Labeler code
0115
Product ID
0115-1748_98ab130e-5fd8-4df6-9e37-e6c3780403cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA013217
Marketing category
NDA
Marketing start
2007-11-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1748-01EA - Each0115-17480404c109-707a-403f-b877-6facd258961312018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1748-0100115174801100 TABLET in 1 BOTTLE (0115-1748-01) 100 tablet2007-11-010000-00-00NoNoCurrent
0115-1748-0200115174802500 TABLET in 1 BOTTLE (0115-1748-02) 500 tablet2007-11-010000-00-00NoNoCurrent