FDA.reportPublic FDA data

Metaxalone

Product NDC
71205-016
11-digit product format
712050016
Labeler code
71205
Product ID
71205-016_4083545a-a990-4820-a601-06a7d8a31a35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207466
Marketing category
ANDA
Marketing start
2017-08-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-016-10Metaxalone10 in 1 BOTTLETABLET104
71205-016-30Metaxalone30 in 1 BOTTLETABLET304
71205-016-60Metaxalone60 in 1 BOTTLETABLET604
71205-016-90Metaxalone90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-016-30EA - Each71205-016cdcf5dcb-2ee4-445e-bfb4-9b0af127411312018-08-13
71205-016-60EA - Each71205-016fcf4fa19-56db-49d0-ba90-399b6eb0d8cd12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-016METAXALONE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240310_9c7d0cd4-625a-485e-9d13-ce854630148c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN9c7d0cd4-625a-485e-9d13-ce854630148c4
351254metaxalone 800 MG Oral TabletSCD9c7d0cd4-625a-485e-9d13-ce854630148c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-016-107120500161010 TABLET in 1 BOTTLE (71205-016-10) 10 tablet2018-04-020000-00-00NoNoCurrent
71205-016-307120500163030 TABLET in 1 BOTTLE (71205-016-30) 30 tablet2018-04-020000-00-00NoNoCurrent
71205-016-607120500166060 TABLET in 1 BOTTLE (71205-016-60) 60 tablet2018-04-020000-00-00NoNoCurrent
71205-016-907120500169090 TABLET in 1 BOTTLE (71205-016-90) 90 tablet2018-04-020000-00-00NoNoCurrent