FDA.reportPublic FDA data

Metaxalone

Product NDC
50268-530
11-digit product format
502680530
Labeler code
50268
Product ID
50268-530_4481b1d7-8b54-035a-e063-6394a90ab23d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA203399
Marketing category
ANDA
Marketing start
2015-03-13
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
50268-530-152022-01-31C16284748780-1d6a99b39-37c1-a426-e053-dadaa90af4c2Metaxalone Tablets
50268-530-152022-01-28C16284748780-1d6a99b39-37c1-a426-e053-dadaa90af4c2Metaxalone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-530-11Metaxalone1 in 1 BLISTER PACKTABLET16
50268-530-15Metaxalone50 in 1 BOX, UNIT-DOSETABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-530-11EA - Each50268-530e7749c75-4f73-40f4-bcbf-9a19d2f7cfd412015-06-09
50268-530-15EA - Each50268-530bb66462e-0be4-4f8a-8294-00d474f0261512015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METAXALONEACTIVE INGREDIENT1NMA9J598YMETAXALONE (METAXALONE) TABLET [AVPAK]1
METAXALONEACTIVE MOIETY1NMA9J598YMETAXALONE (METAXALONE) TABLET [AVPAK]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKMETAXALONE (METAXALONE) TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETAXALONE (METAXALONE) TABLET [AVPAK]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETAXALONE (METAXALONE) TABLET [AVPAK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETAXALONE (METAXALONE) TABLET [AVPAK]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETAXALONE (METAXALONE) TABLET [AVPAK]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETAXALONE (METAXALONE) TABLET [AVPAK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METAXALONE (METAXALONE) TABLET [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METAXALONE (METAXALONE) TABLET [AVPAK]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETAXALONE (METAXALONE) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-530METAXALONE TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_9b21a974-6a5a-9efb-e9de-470363217126.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN9b21a974-6a5a-9efb-e9de-4703632171266
351254metaxalone 800 MG Oral TabletSCD9b21a974-6a5a-9efb-e9de-4703632171266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-530-11502680530111 in 1 BLISTER PACKHistorical
50268-530-155026805301550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11) 50 blister pack2015-03-130000-00-00NoNoCurrent