FDA.reportPublic FDA data

Metaxalone

Product NDC
51655-163
11-digit product format
516550163
Labeler code
51655
Product ID
51655-163_87d1b2d2-6d3e-4828-a956-12f863fd62a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
NDA013217
Marketing category
NDA
Marketing start
2014-04-01
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe1c2a6-5488-f909-3872-734054eb745aProduct name520181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4Product name120150615
68c52498-c9cb-48ab-a792-a4876149361eProduct name120150409

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-163-202026-01-10C16284748780-19d75b9d0-d360-f424-e053-dadaa90a57ce4e5283d0-a1fb-467d-8832-4d833a1d43e4
51655-163-202020-01-31C16284748780-19d75b9d0-d360-f424-e053-dadaa90a57ce4e5283d0-a1fb-467d-8832-4d833a1d43e4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE TABLET [NORTHWIND PHARMACEUTICALS]1
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-163METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140604_4e5283d0-a1fb-467d-8832-4d833a1d43e4.zip