FDA.reportPublic FDA data

Metaxalone

Product NDC
68258-7100
11-digit product format
682587100
Labeler code
68258
Product ID
68258-7100_86de2f42-f64d-4801-98a8-b879a4779840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
68258-7100-12019-10-29C16284748780-1960f7f55-cb48-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg
68258-7100-22019-10-29C16284748780-1960f7f55-cb48-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg
68258-7100-32019-10-29C16284748780-1960f7f55-cb48-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg
68258-7100-62019-10-29C16284748780-1960f7f55-cb48-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg
68258-7100-92019-10-29C16284748780-1960f7f55-cb48-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-7100-1Metaxalone16 in 1 BOTTLETABLET161
68258-7100-2Metaxalone20 in 1 BOTTLETABLET201
68258-7100-3Metaxalone30 in 1 BOTTLETABLET301
68258-7100-6Metaxalone60 in 1 BOTTLETABLET601
68258-7100-9Metaxalone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-7100-3EA - Each68258-7100fd11a8c7-fc94-4fe7-85b8-9cbb4e927e6b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZMETAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1
CALCIUMINACTIVE INGREDIENTSY7Q814VUPMETAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-7100METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 5 package rows20110930_0755d115-dbf4-44ac-a02f-4d8a013902e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN0755d115-dbf4-44ac-a02f-4d8a013902e31
351254metaxalone 800 MG Oral TabletSCD0755d115-dbf4-44ac-a02f-4d8a013902e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-7100-16825871000116 in 1 BOTTLEHistorical
68258-7100-26825871000220 in 1 BOTTLEHistorical
68258-7100-36825871000330 in 1 BOTTLEHistorical
68258-7100-66825871000660 in 1 BOTTLEHistorical
68258-7100-96825871000990 in 1 BOTTLEHistorical