SKELAXIN

Product NDC
55289-736
11-digit product format
552890736
Labeler code
55289
Product ID
55289-736_debe0f76-305b-d83f-e053-2995a90ad3c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA013217
Marketing category
NDA
Marketing start
2002-08-30
Marketing end
2022-11-30
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
55289-736-10EA - Each55289-736743913e9-15eb-4911-b515-cc6166f7b8f312013-02-13
55289-736-15EA - Each55289-73664c1cde6-a385-4a0f-b31d-30ff077854bd12013-02-13
55289-736-20EA - Each55289-7362fd96553-2c44-4360-a497-aad934db63a912013-02-13
55289-736-21EA - Each55289-73678b86e17-6594-43c8-8fff-e22f986a14a612013-02-13
55289-736-30EA - Each55289-736cb700729-2c9c-4aa9-99e6-da9afec9375e12013-02-13
55289-736-40EA - Each55289-736ef00f0a0-9381-43da-8c86-02cf171bac2c12013-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-736-105528907361010 TABLET in 1 BOTTLE, PLASTIC (55289-736-10) 10 tablet2011-09-060000-00-00NoNoCurrent
55289-736-205528907362020 TABLET in 1 BOTTLE, PLASTIC (55289-736-20) 20 tablet2011-09-060000-00-00NoNoCurrent
55289-736-215528907362121 TABLET in 1 BOTTLE, PLASTIC (55289-736-21) 21 tablet2011-09-060000-00-00NoNoCurrent
55289-736-305528907363030 TABLET in 1 BOTTLE, PLASTIC (55289-736-30) 30 tablet2011-09-060000-00-00NoNoCurrent
55289-736-405528907364040 TABLET in 1 BOTTLE, PLASTIC (55289-736-40) 40 tablet2011-09-060000-00-00NoNoCurrent