METAXALONE

Product NDC
61919-262
11-digit product format
619190262
Labeler code
61919
Product ID
61919-262_948f5317-b39f-5d57-e053-2995a90ac991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metaxalone tablet
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA203399
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-262-20METAXALONE20 in 1 BOTTLETABLET202
61919-262-30METAXALONE30 in 1 BOTTLETABLET302
61919-262-60METAXALONE60 in 1 BOTTLETABLET602
61919-262-71METAXALONE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-262-30EA - Each61919-262f484630a-d65c-4fc9-96ba-ab89bae3afc712016-09-02
61919-262-60EA - Each61919-2622f90c9dc-2330-4a21-a70d-35ff78a1e6d712016-09-02
61919-262-71EA - Each61919-262aac01e25-9af2-4eeb-bcfd-37cd64c1275812019-12-10

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-262METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]2Legacy NDC, 4 package rows20191126_e8643c67-c531-4a4f-931d-0e3c91cfc0c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNe8643c67-c531-4a4f-931d-0e3c91cfc0c82
351254metaxalone 800 MG Oral TabletSCDe8643c67-c531-4a4f-931d-0e3c91cfc0c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-262-206191902622020 TABLET in 1 BOTTLE (61919-262-20) 20 tablet2015-01-010000-00-00NoNoCurrent
61919-262-306191902623030 TABLET in 1 BOTTLE (61919-262-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-262-606191902626060 TABLET in 1 BOTTLE (61919-262-60) 60 tablet2015-01-010000-00-00NoNoCurrent
61919-262-7161919026271100 TABLET in 1 BOTTLE (61919-262-71) 100 tablet2015-01-010000-00-00NoNoCurrent