Metaxalone

Product NDC
60760-289
11-digit product format
607600289
Labeler code
60760
Product ID
60760-289_51195db5-d1f3-1fa8-e063-6294a90ae17b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
�St. Mary's Medical Park Pharmacy
Application
ANDA204770
Marketing category
ANDA
Marketing start
2020-03-31
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
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
60760-289-06Metaxalone6 in 1 BOTTLE, PLASTICTABLET65
60760-289-20Metaxalone20 in 1 BOTTLE, PLASTICTABLET205
60760-289-30Metaxalone30 in 1 BOTTLE, PLASTICTABLET305
60760-289-60Metaxalone60 in 1 BOTTLE, PLASTICTABLET605
60760-289-90Metaxalone90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-289METAXALONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]4Current NDC, Legacy NDC, 5 package rows20200618_a23ca660-b066-1396-e053-2a95a90a30b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNa23ca660-b066-1396-e053-2a95a90a30b25
351254metaxalone 800 MG Oral TabletSCDa23ca660-b066-1396-e053-2a95a90a30b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-289-06607600289066 TABLET in 1 BOTTLE, PLASTIC (60760-289-06) 6 tablet2020-06-160000-00-00NoNoCurrent
60760-289-206076002892020 TABLET in 1 BOTTLE, PLASTIC (60760-289-20) 20 tablet2020-03-310000-00-00NoNoCurrent
60760-289-306076002893030 TABLET in 1 BOTTLE, PLASTIC (60760-289-30) 30 tablet2020-03-310000-00-00NoNoCurrent
60760-289-606076002896060 TABLET in 1 BOTTLE, PLASTIC (60760-289-60) 60 tablet2020-04-240000-00-00NoNoCurrent
60760-289-906076002899090 TABLET in 1 BOTTLE, PLASTIC (60760-289-90) 90 tablet2020-03-310000-00-00NoNoCurrent