Metaxalone

Product NDC
68071-2849
11-digit product format
680712849
Labeler code
68071
Product ID
68071-2849_eaeedb0c-bc6a-b131-e053-2a95a90a7ddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204770
Marketing category
ANDA
Marketing start
2016-11-22
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2849-22025-01-30C16284748780-12cef2736-5f7f-d83d-e063-dadaa90ab31fMetaxalone Tablets, USP RX ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2849-2Metaxalone20 in 1 BOTTLETABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2849METAXALONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221014_eaeedfd0-03dd-c924-e053-2a95a90a9995.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNeaeedfd0-03dd-c924-e053-2a95a90a99951
351254metaxalone 800 MG Oral TabletSCDeaeedfd0-03dd-c924-e053-2a95a90a99951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2849-26807128490220 TABLET in 1 BOTTLE (68071-2849-2) 20 tablet2022-10-130000-00-00NoNoCurrent