Metaxalone

Product NDC
10544-002
11-digit product format
105440002
Labeler code
10544
Product ID
10544-002_17b18994-0790-4262-8680-8167fd7f88fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
NDA013217
Marketing category
NDA
Marketing start
2010-05-20
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
10544-002-202019-10-29C16284748780-1960f7f55-d10c-8e05-e053-dbdaa90a074aMETAXALONE TABLETS 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-002-20Metaxalone20 in 1 BOTTLETABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-002-20EA - Each10544-0029af773a7-3b56-4d9b-99c7-b680b6f6a4d812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZMETAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2
CALCIUMINACTIVE INGREDIENTSY7Q814VUPMETAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-002METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20110606_f001063b-6577-4b48-899c-b05684b5e2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNf001063b-6577-4b48-899c-b05684b5e2b12
351254metaxalone 800 MG Oral TabletSCDf001063b-6577-4b48-899c-b05684b5e2b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-002-201054400022020 in 1 BOTTLEHistorical