Metaxalone

Product NDC
74157-018
11-digit product format
741570018
Labeler code
74157
Product ID
74157-018_4a02d857-976b-b4c7-e063-6294a90a655b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
INA Pharmaceutics Inc
Application
NDA022503
Marketing category
NDA
Marketing start
2025-02-10
Substance
METAXALONE
Active strength
640 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metaxalone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METAXALONE640 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NMA9J598Y
Rxcui2627781

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
74157-018-60Metaxalone60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74157-018-60EA - Each74157-018d5aeac52-5d15-4264-bfab-57b32d106f2a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74157-018METAXALONE TABLET [INA PHARMACEUTICS INC]2Current NDC, 1 package rows20250515_fc6de1a6-26aa-47ac-a5d2-bf127a6ca563.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2627781metaxalone 640 MG Oral TabletPSNfc6de1a6-26aa-47ac-a5d2-bf127a6ca5634
2627781metaxalone 640 MG Oral TabletSCDfc6de1a6-26aa-47ac-a5d2-bf127a6ca5634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74157-018-607415700186060 TABLET in 1 BOTTLE (74157-018-60) 60 tablet2025-02-10NoNoHistorical