Metaxalone

Product NDC
33261-724
11-digit product format
332610724
Labeler code
33261
Product ID
33261-724_56cf45ce-a692-486e-a961-3d53f18d418a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA203399
Marketing category
ANDA
Marketing start
2013-05-31
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
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-724-102020-01-31C16284748780-19d75b9cf-f1bb-f424-e053-dadaa90a57ceMetaxalone Tablets
33261-724-162020-01-31C16284748780-19d75b9cf-f1bb-f424-e053-dadaa90a57ceMetaxalone Tablets
33261-724-302020-01-31C16284748780-19d75b9cf-f1bb-f424-e053-dadaa90a57ceMetaxalone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-724-10Metaxalone10 in 1 BOTTLE, PLASTICTABLET101
33261-724-16Metaxalone16 in 1 BOTTLE, PLASTICTABLET161
33261-724-30Metaxalone30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-724-10EA - Each33261-72426ddc84b-c706-40e9-b5d9-01068274ea1412016-09-02
33261-724-16EA - Each33261-72466106813-2150-45b5-8740-2073a4a9f6fa12015-10-02
33261-724-30EA - Each33261-724d6b8adcb-448b-4588-a424-00efbec1bacc12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-724METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_5311bdb3-37a7-48d8-a5bb-5765b3d43fbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN5311bdb3-37a7-48d8-a5bb-5765b3d43fbc1
351254metaxalone 800 MG Oral TabletSCD5311bdb3-37a7-48d8-a5bb-5765b3d43fbc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-724-103326107241010 in 1 BOTTLE, PLASTICHistorical
33261-724-163326107241616 in 1 BOTTLE, PLASTICHistorical
33261-724-303326107243030 in 1 BOTTLE, PLASTICHistorical