FDA.reportPublic FDA data

Metaxalone

Product NDC
71205-426
11-digit product format
712050426
Labeler code
71205
Product ID
71205-426_8a05b052-c0ab-4cb1-af99-1d9c65024412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204770
Marketing category
ANDA
Marketing start
2016-11-22
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
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
71205-426-14Metaxalone14 in 1 BOTTLETABLET143
71205-426-20Metaxalone20 in 1 BOTTLETABLET203
71205-426-30Metaxalone30 in 1 BOTTLETABLET303
71205-426-60Metaxalone60 in 1 BOTTLETABLET603
71205-426-90Metaxalone90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-426-14EA - Each71205-4268acfdb42-7252-48ca-b298-dc2e40d21fa112022-05-04
71205-426-20EA - Each71205-4263beb6ae8-590a-4225-8191-2d73bc27b24512022-05-04
71205-426-30EA - Each71205-426e8c63334-7615-466c-a218-665a6700b5f312020-08-06
71205-426-60EA - Each71205-426d7f4bdca-1160-446a-b22c-53adf0f8c5d612020-05-08
71205-426-90EA - Each71205-426a12d052c-d3f1-4d54-89ef-dbc89d2a3a9c12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-426METAXALONE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20220413_ee86f52c-fbf4-4882-bb7d-50220736fbb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNee86f52c-fbf4-4882-bb7d-50220736fbb33
351254metaxalone 800 MG Oral TabletSCDee86f52c-fbf4-4882-bb7d-50220736fbb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-426-147120504261414 TABLET in 1 BOTTLE (71205-426-14) 14 tablet2022-01-050000-00-00NoNoCurrent
71205-426-207120504262020 TABLET in 1 BOTTLE (71205-426-20) 20 tablet2022-01-050000-00-00NoNoCurrent
71205-426-307120504263030 TABLET in 1 BOTTLE (71205-426-30) 30 tablet2020-03-110000-00-00NoNoCurrent
71205-426-607120504266060 TABLET in 1 BOTTLE (71205-426-60) 60 tablet2020-03-110000-00-00NoNoCurrent
71205-426-907120504269090 TABLET in 1 BOTTLE (71205-426-90) 90 tablet2020-03-110000-00-00NoNoCurrent