FDA.reportPublic FDA data

Metaxalone

Product NDC
80425-0084
11-digit product format
804250084
Labeler code
80425
Product ID
80425-0084_2a990578-5a3d-aeda-e063-6294a90af6fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA203399
Marketing category
ANDA
Marketing start
2013-05-31
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metaxalone
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0084-2Metaxalone60 in 1 BOTTLETABLET606
80425-0084-3Metaxalone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0084-2EA - Each80425-00840bd6001e-21e6-4e1b-bd92-81beae16e8bf12023-06-06
80425-0084-3EA - Each80425-00849c842557-3d8c-4065-8b60-eec73de87d7512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0084METAXALONE TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_b3279496-293e-7e1f-e053-2a95a90ab506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNb3279496-293e-7e1f-e053-2a95a90ab5066
351254metaxalone 800 MG Oral TabletSCDb3279496-293e-7e1f-e053-2a95a90ab5066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0084-28042500840260 TABLET in 1 BOTTLE (80425-0084-2) 60 tablet2013-05-310000-00-00NoNoCurrent
80425-0084-38042500840390 TABLET in 1 BOTTLE (80425-0084-3) 90 tablet2013-05-310000-00-00NoNoCurrent