Metaxalone

Product NDC
50090-3670
11-digit product format
500903670
Labeler code
50090
Product ID
50090-3670_ec03cd72-1671-4b35-8100-8000cc5d4531
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3670-02023-02-07C16284748780-1f386c649-f064-0266-e053-dadaa90a7c1aMetaxalone Tablets, USP RX ONLY
50090-3670-02023-01-30C16284748780-1f386c649-f064-0266-e053-dadaa90a7c1aMetaxalone Tablets, USP RX ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3670-0Metaxalone20 in 1 BOTTLETABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3670-0EA - Each50090-3670f8dda8a0-7f77-4c64-bbc6-994ae23525d412021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3670METAXALONE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231002_ef47682d-ea41-465e-aa21-cc773d45a6f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNef47682d-ea41-465e-aa21-cc773d45a6f06
351254metaxalone 800 MG Oral TabletSCDef47682d-ea41-465e-aa21-cc773d45a6f06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3670-05009036700020 TABLET in 1 BOTTLE (50090-3670-0) 20 tablet2018-10-160000-00-00NoNoCurrent