FDA.reportPublic FDA data

Metaxalone

Product NDC
76420-898
11-digit product format
764200898
Labeler code
76420
Product ID
76420-898_4fa17239-3e4c-a50f-e063-6394a90a4de5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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
76420-898-01Metaxalone100 in 1 BOTTLETABLET1003
76420-898-12Metaxalone12 in 1 BOTTLETABLET123
76420-898-15Metaxalone15 in 1 BOTTLETABLET153
76420-898-20Metaxalone20 in 1 BOTTLETABLET203
76420-898-30Metaxalone30 in 1 BOTTLETABLET303
76420-898-60Metaxalone60 in 1 BOTTLETABLET603
76420-898-90Metaxalone90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-898-01EA - Each76420-89832cb5107-ae54-405f-bbfc-4a8d5f6092c012026-05-22
76420-898-12EA - Each76420-898c01ec81a-8f12-4889-9e30-210a86051f4b12026-05-22
76420-898-15EA - Each76420-898a8859ee7-35ae-4c40-8ea3-c30eb7bb4e2912026-05-22
76420-898-20EA - Each76420-8980ac142b0-2904-45be-a820-7b4b0b356c1412026-05-22
76420-898-30EA - Each76420-898b7335ca3-19c9-4b35-98cf-a1614045e23d12026-05-22
76420-898-60EA - Each76420-89847749ded-1d36-4de9-8df2-54789dca765812026-05-22
76420-898-90EA - Each76420-898c8c94b41-b0af-43c9-baa5-ca770178076c12026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-898METAXALONE TABLET [ASCLEMED USA, INC.]2Current NDC, 7 package rows20250515_f4a0e910-2b20-46d4-b49e-21fb15925b58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNf4a0e910-2b20-46d4-b49e-21fb15925b583
351254metaxalone 800 MG Oral TabletSCDf4a0e910-2b20-46d4-b49e-21fb15925b583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-898-0176420089801100 TABLET in 1 BOTTLE (76420-898-01) 100 tablet2025-01-10NoNoHistorical
76420-898-127642008981212 TABLET in 1 BOTTLE (76420-898-12) 12 tablet2025-05-13NoNoHistorical
76420-898-157642008981515 TABLET in 1 BOTTLE (76420-898-15) 15 tablet2025-01-10NoNoHistorical
76420-898-207642008982020 TABLET in 1 BOTTLE (76420-898-20) 20 tablet2025-01-10NoNoHistorical
76420-898-307642008983030 TABLET in 1 BOTTLE (76420-898-30) 30 tablet2025-01-10NoNoHistorical
76420-898-607642008986060 TABLET in 1 BOTTLE (76420-898-60) 60 tablet2025-01-10NoNoHistorical
76420-898-907642008989090 TABLET in 1 BOTTLE (76420-898-90) 90 tablet2025-01-10NoNoHistorical