FDA.reportPublic FDA data

Metaxalone

Product NDC
51655-162
11-digit product format
516550162
Labeler code
51655
Product ID
51655-162_69c4836e-6de5-4525-8689-b81c3fd807cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA203399
Marketing category
ANDA
Marketing start
2014-02-12
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
51655-162-102026-01-10C16284748780-19d75b9d0-1b8e-f424-e053-dadaa90a57ce5a0f574e-df84-4682-83eb-87272a7f5294
51655-162-202026-01-10C16284748780-19d75b9d0-1b8e-f424-e053-dadaa90a57ce5a0f574e-df84-4682-83eb-87272a7f5294
51655-162-102020-01-31C16284748780-19d75b9d0-1b8e-f424-e053-dadaa90a57ce5a0f574e-df84-4682-83eb-87272a7f5294
51655-162-202020-01-31C16284748780-19d75b9d0-1b8e-f424-e053-dadaa90a57ce5a0f574e-df84-4682-83eb-87272a7f5294

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
51655-162METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140617_5a0f574e-df84-4682-83eb-87272a7f5294.zip