FDA.reportPublic FDA data

Metaxalone

Product NDC
80425-0131
11-digit product format
804250131
Labeler code
80425
Product ID
80425-0131_2a998081-6431-8228-e063-6294a90adc3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA203695
Marketing category
ANDA
Marketing start
2017-06-19
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
80425-0131-2Metaxalone60 in 1 BOTTLETABLET606
80425-0131-3Metaxalone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0131-2EA - Each80425-0131f41d036b-50df-469b-a98b-c2ac09f3462812023-06-06
80425-0131-3EA - Each80425-01317cc5b478-0754-412b-9554-ad6503ffc57612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0131METAXALONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_bd1c9022-aadc-af1f-e053-2995a90a0b42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNbd1c9022-aadc-af1f-e053-2995a90a0b426
351254metaxalone 800 MG Oral TabletSCDbd1c9022-aadc-af1f-e053-2995a90a0b426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0131-28042501310260 TABLET in 1 BOTTLE (80425-0131-2) 60 tablet2017-06-190000-00-00NoNoCurrent
80425-0131-38042501310390 TABLET in 1 BOTTLE (80425-0131-3) 90 tablet2017-06-190000-00-00NoNoCurrent