FDA.reportPublic FDA data

Metaxalone

Product NDC
50228-323
11-digit product format
502280323
Labeler code
50228
Product ID
50228-323_2fa7c2d7-03c0-4f7e-aa18-d586e157e177
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
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
Rxcui197935, 351254

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
50228-323-01Metaxalone100 in 1 BOTTLETABLET1003
50228-323-05Metaxalone500 in 1 BOTTLETABLET5003
50228-323-30Metaxalone30 in 1 BOTTLETABLET303
50228-323-01Metaxalone100 in 1 BOTTLETABLET1002
50228-323-05Metaxalone500 in 1 BOTTLETABLET5002
50228-323-30Metaxalone30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-323-01EA - Each50228-323c6e69fca-9fed-428e-b2d6-13f8172949ae12021-06-02
50228-323-05EA - Each50228-32359902ed7-908a-4ab0-bb98-7553dc58fa6d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-323METAXALONE TABLET [SCIEGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20210710_cec5b74b-8a5d-4474-8a70-ab44f5bf7bd4.zip
50228-323METAXALONE TABLET [SCIEGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20240829_1cef46bb-e590-4a58-82e0-7cf1fc3836a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNcec5b74b-8a5d-4474-8a70-ab44f5bf7bd43
351254metaxalone 800 MG Oral TabletSCDcec5b74b-8a5d-4474-8a70-ab44f5bf7bd43
197935metaxalone 400 MG Oral TabletPSN1cef46bb-e590-4a58-82e0-7cf1fc3836a52
351254metaxalone 800 MG Oral TabletPSN1cef46bb-e590-4a58-82e0-7cf1fc3836a52
197935metaxalone 400 MG Oral TabletSCD1cef46bb-e590-4a58-82e0-7cf1fc3836a52
351254metaxalone 800 MG Oral TabletSCD1cef46bb-e590-4a58-82e0-7cf1fc3836a52
351254metaxalone 800 MG Oral TabletPSN4facde6f-1828-9138-e063-6294a90a1ec11
351254metaxalone 800 MG Oral TabletPSNfe82b33b-2a24-4477-91ca-b23e591566751
351254metaxalone 800 MG Oral TabletSCD4facde6f-1828-9138-e063-6294a90a1ec11
351254metaxalone 800 MG Oral TabletSCDfe82b33b-2a24-4477-91ca-b23e591566751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-323-0150228032301100 TABLET in 1 BOTTLE (50228-323-01) 100 tablet2017-08-310000-00-00NoNoCurrent
50228-323-0550228032305500 TABLET in 1 BOTTLE (50228-323-05) 500 tablet2017-08-310000-00-00NoNoCurrent
50228-323-305022803233030 TABLET in 1 BOTTLE (50228-323-30) 30 tablet2017-08-310000-00-00NoNoCurrent