FDA.reportPublic FDA data

Metaxalone

Product NDC
70518-0771
11-digit product format
705180771
Labeler code
70518
Product ID
70518-0771_4836b7ef-044d-fe73-e063-6294a90ace99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204770
Marketing category
ANDA
Marketing start
2017-10-09
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metaxalone
Listing expiration
2027-12-31

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
70518-0771-0Metaxalone90 in 1 BOTTLE, PLASTICTABLET9017
70518-0771-1Metaxalone30 in 1 BOTTLE, PLASTICTABLET3017
70518-0771-2Metaxalone60 in 1 BOTTLE, PLASTICTABLET6017
70518-0771-3Metaxalone25 in 1 BOTTLE, PLASTICTABLET2517
70518-0771-4Metaxalone120 in 1 BOTTLE, PLASTICTABLET12017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0771-0EA - Each70518-07715f71988f-a72b-4fce-b122-1f240682595c12026-01-08
70518-0771-1EA - Each70518-0771cfaaa704-cf84-4ad1-bbf8-28787879536d12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0771METAXALONE TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 5 package rows20250429_e9e45029-b1a4-435f-b9ca-cdfa01051bc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNe9e45029-b1a4-435f-b9ca-cdfa01051bc817
351254metaxalone 800 MG Oral TabletSCDe9e45029-b1a4-435f-b9ca-cdfa01051bc817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0771-07051807710090 TABLET in 1 BOTTLE, PLASTIC (70518-0771-0) 90 tablet2017-10-090000-00-00NoNoCurrent
70518-0771-17051807710130 TABLET in 1 BOTTLE, PLASTIC (70518-0771-1) 30 tablet2019-01-140000-00-00NoNoCurrent
70518-0771-27051807710260 TABLET in 1 BOTTLE, PLASTIC (70518-0771-2) 60 tablet2019-04-160000-00-00NoNoCurrent
70518-0771-37051807710325 TABLET in 1 BOTTLE, PLASTIC (70518-0771-3) 25 tablet2020-03-240000-00-00NoNoCurrent
70518-0771-470518077104120 TABLET in 1 BOTTLE, PLASTIC (70518-0771-4) 120 tablet2024-06-26NoNoHistorical