Metaxalone

Product NDC
42254-040
11-digit product format
422540040
Labeler code
42254
Product ID
42254-040_b28a2d3c-69ca-4c97-915b-41135b9b5bc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
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
42254-040-302019-09-24C16284748780-19350213a-3bf0-c013-e053-90daa90a1393METAXALONE TABLETS 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-040-30Metaxalone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-040-30EA - Each42254-040ee9a0899-25d5-4fe9-8cb3-6148530bbe2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE TABLET [REBEL DISTRIBUTORS CORP]1
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE TABLET [REBEL DISTRIBUTORS CORP]1
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZMETAXALONE TABLET [REBEL DISTRIBUTORS CORP]1
CALCIUMINACTIVE INGREDIENTSY7Q814VUPMETAXALONE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METAXALONE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETAXALONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-040METAXALONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_b28a2d3c-69ca-4c97-915b-41135b9b5bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNb28a2d3c-69ca-4c97-915b-41135b9b5bc01
351254metaxalone 800 MG Oral TabletSCDb28a2d3c-69ca-4c97-915b-41135b9b5bc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-040-304225400403030 in 1 BOTTLEHistorical