SKELAXIN

Product NDC
10544-524
11-digit product format
105440524
Labeler code
10544
Product ID
10544-524_11a55d5f-72ba-0b65-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
NDA013217
Marketing category
NDA
Marketing start
2010-03-15
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
10544-524-202020-01-31C16284748780-19d75b9d0-2d64-f424-e053-dadaa90a57ceSKELAXIN ® (Metaxalone) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-524-20SKELAXIN20 in 1 BOTTLETABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-524-20EA - Each10544-524049f2fc7-1874-4c0b-8565-b88192a5dfc312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YSKELAXIN (METAXALONE) TABLET [BLENHEIM PHARMACAL, INC.]1
METAXALONEACTIVE MOIETY1NMA9J598YSKELAXIN (METAXALONE) TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-524SKELAXIN (METAXALONE) TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150319_11a55d5f-72b9-0b65-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN11a55d5f-72b9-0b65-e054-00144ff88e881
352277Skelaxin 800 MG Oral TabletPSN11a55d5f-72b9-0b65-e054-00144ff88e881
352277metaxalone 800 MG Oral Tablet [Skelaxin]SBD11a55d5f-72b9-0b65-e054-00144ff88e881
351254metaxalone 800 MG Oral TabletSCD11a55d5f-72b9-0b65-e054-00144ff88e881
352277Skelaxin 800 MG Oral TabletSY11a55d5f-72b9-0b65-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-524-201054405242020 in 1 BOTTLEHistorical