FDA.reportPublic FDA data

Metaxalone

Product NDC
80425-0122
11-digit product format
804250122
Labeler code
80425
Product ID
80425-0122_2a99aae5-c903-7940-e063-6294a90a4146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA204770
Marketing category
ANDA
Marketing start
2016-11-22
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
80425-0122-1Metaxalone30 in 1 BOTTLETABLET307
80425-0122-2Metaxalone60 in 1 BOTTLETABLET607
80425-0122-3Metaxalone90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0122-1EA - Each80425-0122fd38f6a3-d0da-4a2d-829e-ddf6685746bc12023-04-07
80425-0122-2EA - Each80425-01223cf8b25b-f836-48b3-85c5-8dbc14a522b912023-04-07
80425-0122-3EA - Each80425-012290c8319a-268f-420c-8409-a3357118e5c412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0122METAXALONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_b713a0f2-d47a-0ae7-e053-2995a90a5b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNb713a0f2-d47a-0ae7-e053-2995a90a5b857
351254metaxalone 800 MG Oral TabletSCDb713a0f2-d47a-0ae7-e053-2995a90a5b857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0122-18042501220130 TABLET in 1 BOTTLE (80425-0122-1) 30 tablet2016-11-22NoNoHistorical
80425-0122-28042501220260 TABLET in 1 BOTTLE (80425-0122-2) 60 tablet2016-11-220000-00-00NoNoCurrent
80425-0122-38042501220390 TABLET in 1 BOTTLE (80425-0122-3) 90 tablet2016-11-220000-00-00NoNoCurrent