Metaxalone

Product NDC
67296-1577
11-digit product format
672961577
Labeler code
67296
Product ID
67296-1577_d61c0ce9-95b3-7a53-e053-2995a90a9f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA207466
Marketing category
ANDA
Marketing start
2018-01-01
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
67296-1577-52024-01-30C16284748780-11030e365-3ad1-111a-e063-dadaa90a10e2metaxalone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1577-5Metaxalone15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1577METAXALONE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_686b8c39-4ed8-4d69-e053-2991aa0a579d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN686b8c39-4ed8-4d69-e053-2991aa0a579d4
351254metaxalone 800 MG Oral TabletSCD686b8c39-4ed8-4d69-e053-2991aa0a579d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1577-56729615770515 TABLET in 1 BOTTLE (67296-1577-5) 15 tablet2018-01-010000-00-00NoNoCurrent