FDA.reportPublic FDA data

METAXALONE

Product NDC
61919-832
11-digit product format
619190832
Labeler code
61919
Product ID
61919-832_47e15fc2-987b-4fa9-e063-6294a90adf51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METAXALONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204770
Marketing category
ANDA
Marketing start
2019-05-03
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METAXALONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METAXALONE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NMA9J598Y
Rxcui351254

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
61919-832-302025-01-30C16284748780-12cef2736-66ad-d83d-e063-dadaa90ab31fMetaxalone
61919-832-602025-01-30C16284748780-12cef2736-9095-d83d-e063-dadaa90ab31fMetaxalone
61919-832-712025-01-30C16284748780-12cef2736-5a1d-d83d-e063-dadaa90ab31fMETAXALONE
61919-832-722025-01-30C16284748780-12cef2736-5a1d-d83d-e063-dadaa90ab31fMETAXALONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-832-90METAXALONE90 in 1 BOTTLETABLET904
61919-832-71METAXALONE100 in 1 BOTTLETABLET1003
61919-832-72METAXALONE120 in 1 BOTTLETABLET1203
61919-832-30Metaxalone30 in 1 BOTTLETABLET302
61919-832-60Metaxalone60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-832METAXALONE TABLET [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20240110_49250bbf-fbfe-07cd-e054-00144ff88e88.zip
61919-832METAXALONE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 2 package rows20220930_9b7b4fc3-3f38-db66-e053-2995a90aaadb.zip
61919-832METAXALONE TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190627_8c3bc0a2-5c93-e1d6-e053-2995a90a0b83.zip
61919-832METAXALONE TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190830_91432cd0-8404-8029-e053-2a95a90adc1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN49250bbf-fbfe-07cd-e054-00144ff88e884
351254metaxalone 800 MG Oral TabletSCD49250bbf-fbfe-07cd-e054-00144ff88e884
351254metaxalone 800 MG Oral TabletPSN9b7b4fc3-3f38-db66-e053-2995a90aaadb3
351254metaxalone 800 MG Oral TabletSCD9b7b4fc3-3f38-db66-e053-2995a90aaadb3
351254metaxalone 800 MG Oral TabletPSN8c3bc0a2-5c93-e1d6-e053-2995a90a0b832
351254metaxalone 800 MG Oral TabletPSN91432cd0-8404-8029-e053-2a95a90adc1b2
351254metaxalone 800 MG Oral TabletSCD8c3bc0a2-5c93-e1d6-e053-2995a90a0b832
351254metaxalone 800 MG Oral TabletSCD91432cd0-8404-8029-e053-2a95a90adc1b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-832-306191908323030 TABLET in 1 BOTTLE (61919-832-30) 30 tablet2019-06-260000-00-00NoNoCurrent
61919-832-606191908326060 TABLET in 1 BOTTLE (61919-832-60) 60 tablet2019-08-290000-00-00NoNoCurrent
61919-832-7161919083271100 TABLET in 1 BOTTLE (61919-832-71) 100 tablet2020-01-060000-00-00NoNoCurrent
61919-832-7261919083272120 TABLET in 1 BOTTLE (61919-832-72) 120 tablet2020-01-060000-00-00NoNoCurrent
61919-832-906191908329090 TABLET in 1 BOTTLE (61919-832-90) 90 tablet2019-05-030000-00-00NoNoCurrent