FDA.reportPublic FDA data

Metaxalone

Product NDC
72789-028
11-digit product format
727890028
Labeler code
72789
Product ID
72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx 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
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
72789-028-15Metaxalone15 in 1 BOTTLE, PLASTICTABLET1513
72789-028-30Metaxalone30 in 1 BOTTLE, PLASTICTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-028-15EA - Each72789-0285a52c898-9234-40e3-a790-769daa5c741012020-01-03
72789-028-30EA - Each72789-028e210a862-85bd-4e6d-a286-1a7e15ae222412020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-028METAXALONE TABLET [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20250206_edc6ba8d-2d45-4833-8dc7-e2d4e5d72856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNedc6ba8d-2d45-4833-8dc7-e2d4e5d7285613
351254metaxalone 800 MG Oral TabletSCDedc6ba8d-2d45-4833-8dc7-e2d4e5d7285613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-028-157278900281515 TABLET in 1 BOTTLE, PLASTIC (72789-028-15) 15 tablet2019-11-190000-00-00NoNoCurrent
72789-028-307278900283030 TABLET in 1 BOTTLE, PLASTIC (72789-028-30) 30 tablet2019-11-110000-00-00NoNoCurrent