Metaxalone

Product NDC
63187-490
11-digit product format
631870490
Labeler code
63187
Product ID
63187-490_37b601ca-6b00-44c1-8b4c-f9e007190df0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203399
Marketing category
ANDA
Marketing start
2013-05-31
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
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
63187-490-10Metaxalone10 in 1 BOTTLETABLET105
63187-490-30Metaxalone30 in 1 BOTTLETABLET305
63187-490-60Metaxalone60 in 1 BOTTLETABLET605
63187-490-90Metaxalone90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-490-30EA - Each63187-4903b4b16ff-5025-4f09-a09b-0534b6cd240712018-07-03
63187-490-60EA - Each63187-49069db91a5-b553-4e65-97e5-17aa9a3f465912019-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-490METAXALONE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20221021_fba1601d-3ac4-41cf-9548-35ec4994a95e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNfba1601d-3ac4-41cf-9548-35ec4994a95e5
351254metaxalone 800 MG Oral TabletSCDfba1601d-3ac4-41cf-9548-35ec4994a95e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-490-106318704901010 TABLET in 1 BOTTLE (63187-490-10) 10 tablet2015-02-020000-00-00NoNoCurrent
63187-490-306318704903030 TABLET in 1 BOTTLE (63187-490-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-490-606318704906060 TABLET in 1 BOTTLE (63187-490-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-490-906318704909090 TABLET in 1 BOTTLE (63187-490-90) 90 tablet2015-02-020000-00-00NoNoCurrent