FDA.reportPublic FDA data

Metaxalone

Product NDC
60760-093
11-digit product format
607600093
Labeler code
60760
Product ID
60760-093_50c7d5bf-ab64-ef1f-e063-6294a90a9e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA203695
Marketing category
ANDA
Marketing start
2017-06-19
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
60760-093-06Metaxalone6 in 1 BOTTLE, PLASTICTABLET611
60760-093-20Metaxalone20 in 1 BOTTLE, PLASTICTABLET2011
60760-093-30Metaxalone30 in 1 BOTTLE, PLASTICTABLET3011
60760-093-60Metaxalone60 in 1 BOTTLE, PLASTICTABLET6011
60760-093-90Metaxalone90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-093-06EA - Each60760-093b52c04f5-0840-4771-903b-b1f3c5f2c6a812018-06-11
60760-093-20EA - Each60760-093fcaf7cad-6b7b-43f2-9280-2bfcc90c159112017-12-14
60760-093-30EA - Each60760-093932d0fad-1c2b-440b-9ddd-ab4ee1db479912018-02-20
60760-093-60EA - Each60760-093e5e60652-fbf5-488d-828f-b15a72fc22bc12018-08-13
60760-093-90EA - Each60760-0932e940d9b-b806-4fd6-8d92-23933912011112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-093METAXALONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]7Current NDC, Legacy NDC, 5 package rows20241215_5de36266-3964-5aca-e053-2991aa0a2205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN5de36266-3964-5aca-e053-2991aa0a220511
351254metaxalone 800 MG Oral TabletSCD5de36266-3964-5aca-e053-2991aa0a220511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-093-06607600093066 TABLET in 1 BOTTLE, PLASTIC (60760-093-06) 6 tablet2018-04-240000-00-00NoNoCurrent
60760-093-206076000932020 TABLET in 1 BOTTLE, PLASTIC (60760-093-20) 20 tablet2017-11-100000-00-00NoNoCurrent
60760-093-306076000933030 TABLET in 1 BOTTLE, PLASTIC (60760-093-30) 30 tablet2017-11-100000-00-00NoNoCurrent
60760-093-606076000936060 TABLET in 1 BOTTLE, PLASTIC (60760-093-60) 60 tablet2018-06-280000-00-00NoNoCurrent
60760-093-906076000939090 TABLET in 1 BOTTLE, PLASTIC (60760-093-90) 90 tablet2026-03-250000-00-00NoNoCurrent