FDA.reportPublic FDA data

Metaxalone

Product NDC
85766-143
11-digit product format
857660143
Labeler code
85766
Product ID
85766-143_4eb1c8ee-001a-5379-e063-6294a90a2fac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA204770
Marketing category
ANDA
Marketing start
2016-11-22
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
85766-143-01Metaxalone100 in 1 BOTTLETABLET1003
85766-143-06Metaxalone6 in 1 BOTTLETABLET63
85766-143-12Metaxalone12 in 1 BOTTLETABLET123
85766-143-15Metaxalone15 in 1 BOTTLETABLET153
85766-143-20Metaxalone20 in 1 BOTTLETABLET203
85766-143-30Metaxalone30 in 1 BOTTLETABLET303
85766-143-60Metaxalone60 in 1 BOTTLETABLET603
85766-143-90Metaxalone90 in 1 BOTTLETABLET903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN3e7efad7-2752-4f7d-ba30-40f17d13e4c33
351254metaxalone 800 MG Oral TabletSCD3e7efad7-2752-4f7d-ba30-40f17d13e4c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-143-0185766014301100 TABLET in 1 BOTTLE (85766-143-01) 100 tablet2026-02-03NoNoHistorical
85766-143-06857660143066 TABLET in 1 BOTTLE (85766-143-06) 6 tablet2026-04-05NoNoHistorical
85766-143-128576601431212 TABLET in 1 BOTTLE (85766-143-12) 12 tablet2026-03-11NoNoHistorical
85766-143-158576601431515 TABLET in 1 BOTTLE (85766-143-15) 15 tablet2026-03-11NoNoHistorical
85766-143-208576601432020 TABLET in 1 BOTTLE (85766-143-20) 20 tablet2026-03-11NoNoHistorical
85766-143-308576601433030 TABLET in 1 BOTTLE (85766-143-30) 30 tablet2026-02-03NoNoHistorical
85766-143-608576601436060 TABLET in 1 BOTTLE (85766-143-60) 60 tablet2026-02-03NoNoHistorical
85766-143-908576601439090 TABLET in 1 BOTTLE (85766-143-90) 90 tablet2026-02-03NoNoHistorical