FDA.reportPublic FDA data

Metaxalone

Product NDC
71335-0375
11-digit product format
713350375
Labeler code
71335
Product ID
71335-0375_b97be1a8-3fbc-4207-b88e-18ed1f3ca33c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203695
Marketing category
ANDA
Marketing start
2017-06-19
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
71335-0375-0Metaxalone100 in 1 BOTTLETABLET10011
71335-0375-1Metaxalone30 in 1 BOTTLETABLET3011
71335-0375-2Metaxalone20 in 1 BOTTLETABLET2011
71335-0375-3Metaxalone90 in 1 BOTTLETABLET9011
71335-0375-4Metaxalone120 in 1 BOTTLETABLET12011
71335-0375-5Metaxalone15 in 1 BOTTLETABLET1511
71335-0375-6Metaxalone10 in 1 BOTTLETABLET1011
71335-0375-7Metaxalone60 in 1 BOTTLETABLET6011
71335-0375-8Metaxalone16 in 1 BOTTLETABLET1611
71335-0375-9Metaxalone84 in 1 BOTTLETABLET8411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0375-1EA - Each71335-03754c7fb24f-6e14-4f0e-9b63-9f5d9f4487e212018-04-19
71335-0375-2EA - Each71335-03758ac4ddd1-fdd8-4f08-acee-17578db866d512018-06-11
71335-0375-7EA - Each71335-0375e2115d85-b54f-4840-aef0-277d292564a712018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0375METAXALONE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240919_c2dd7071-cba3-410c-ade5-9d7e5af42038.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNc2dd7071-cba3-410c-ade5-9d7e5af4203811
351254metaxalone 800 MG Oral TabletSCDc2dd7071-cba3-410c-ade5-9d7e5af4203811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-0375-071335037500100 TABLET in 1 BOTTLE (71335-0375-0) 100 tablet2018-11-30NoNoHistorical
71335-0375-17133503750130 TABLET in 1 BOTTLE (71335-0375-1) 30 tablet2018-11-30NoNoHistorical
71335-0375-27133503750220 TABLET in 1 BOTTLE (71335-0375-2) 20 tablet2018-11-30NoNoHistorical
71335-0375-37133503750390 TABLET in 1 BOTTLE (71335-0375-3) 90 tablet2018-11-30NoNoHistorical
71335-0375-471335037504120 TABLET in 1 BOTTLE (71335-0375-4) 120 tablet2018-11-30NoNoHistorical
71335-0375-57133503750515 TABLET in 1 BOTTLE (71335-0375-5) 15 tablet2018-11-30NoNoHistorical
71335-0375-67133503750610 TABLET in 1 BOTTLE (71335-0375-6) 10 tablet2018-11-30NoNoHistorical
71335-0375-77133503750760 TABLET in 1 BOTTLE (71335-0375-7) 60 tablet2018-11-30NoNoHistorical
71335-0375-87133503750816 TABLET in 1 BOTTLE (71335-0375-8) 16 tablet2018-11-30NoNoHistorical
71335-0375-97133503750984 TABLET in 1 BOTTLE (71335-0375-9) 84 tablet2018-11-30NoNoHistorical