FDA.reportPublic FDA data

Metaxalone

Product NDC
68788-7675
11-digit product format
687887675
Labeler code
68788
Product ID
68788-7675_c7c7181f-dcf4-455a-8167-abc4ee482cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204770
Marketing category
ANDA
Marketing start
2020-03-02
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
68788-7675-0Metaxalone15 in 1 BOTTLETABLET155
68788-7675-1Metaxalone100 in 1 BOTTLETABLET1005
68788-7675-2Metaxalone20 in 1 BOTTLETABLET205
68788-7675-3Metaxalone30 in 1 BOTTLETABLET305
68788-7675-6Metaxalone60 in 1 BOTTLETABLET605
68788-7675-9Metaxalone90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7675-0EA - Each68788-7675f3b7a870-bc54-43d5-80af-3f163b708eba12020-06-05
68788-7675-1EA - Each68788-7675ae23585e-b9ce-4306-bcf5-6eff0b69378212020-06-05
68788-7675-2EA - Each68788-7675f9a70733-7521-4015-93c0-6a770581493d12020-06-05
68788-7675-3EA - Each68788-7675f3a04df7-4645-4292-b492-f407fda79ae012020-06-05
68788-7675-6EA - Each68788-767578ab81e4-2af3-45f3-8599-cff09518503312020-06-05
68788-7675-9EA - Each68788-76750700a526-7ae6-4ace-9a24-662279258e5512020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7675METAXALONE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20250117_1541da6a-7681-40bc-b67e-28e02a950d72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN1541da6a-7681-40bc-b67e-28e02a950d725
351254metaxalone 800 MG Oral TabletSCD1541da6a-7681-40bc-b67e-28e02a950d725

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7675-06878876750015 TABLET in 1 BOTTLE (68788-7675-0) 15 tablet2020-03-020000-00-00NoNoCurrent
68788-7675-168788767501100 TABLET in 1 BOTTLE (68788-7675-1) 100 tablet2020-03-020000-00-00NoNoCurrent
68788-7675-26878876750220 TABLET in 1 BOTTLE (68788-7675-2) 20 tablet2020-03-020000-00-00NoNoCurrent
68788-7675-36878876750330 TABLET in 1 BOTTLE (68788-7675-3) 30 tablet2020-03-020000-00-00NoNoCurrent
68788-7675-66878876750660 TABLET in 1 BOTTLE (68788-7675-6) 60 tablet2020-03-020000-00-00NoNoCurrent
68788-7675-96878876750990 TABLET in 1 BOTTLE (68788-7675-9) 90 tablet2020-03-020000-00-00NoNoCurrent