Metaxalone

Product NDC
69336-130
11-digit product format
693360130
Labeler code
69336
Product ID
69336-130_d3781696-6926-4c24-b3e3-c63542435e36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Sterling-Knight Pharmaceuticals, LLC
Application
ANDA207466
Marketing category
ANDA
Marketing start
2020-06-03
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
400 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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
69336-130-012022-01-28C16284748780-1d6a99b39-f49b-a426-e053-dadaa90af4c2METAXALONE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-130-01Metaxalone100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-130-01EA - Each69336-130ea2c0eab-85c3-42db-b638-8651c134a2d212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-130METAXALONE TABLET [STERLING-KNIGHT PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20200604_168c539d-3637-4a43-a8b6-cd8e82cf6342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197935metaxalone 400 MG Oral TabletPSN168c539d-3637-4a43-a8b6-cd8e82cf63421
197935metaxalone 400 MG Oral TabletSCD168c539d-3637-4a43-a8b6-cd8e82cf63421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69336-130-0169336013001100 TABLET in 1 BOTTLE (69336-130-01) 100 tablet2020-06-030000-00-00NoNoCurrent