FDA.reportPublic FDA data

Metaxalone

Product NDC
63629-8014
11-digit product format
636298014
Labeler code
63629
Product ID
63629-8014_1ef2ad5e-9806-44ab-9760-b73ebd2084cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metaxalone
Listing expiration
2026-12-31

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
63629-8014-1Metaxalone30 in 1 BOTTLETABLET3010
63629-8014-2Metaxalone90 in 1 BOTTLETABLET9010
63629-8014-3Metaxalone100 in 1 BOTTLETABLET10010
63629-8014-4Metaxalone60 in 1 BOTTLETABLET6010
63629-8014-5Metaxalone10 in 1 BOTTLETABLET1010
63629-8014-6Metaxalone20 in 1 BOTTLETABLET2010
63629-8014-7Metaxalone120 in 1 BOTTLETABLET12010
63629-8014-8Metaxalone15 in 1 BOTTLETABLET1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8014-1EA - Each63629-8014aed0c3cb-758d-43d7-a34a-4e6362e7643812021-01-08
63629-8014-2EA - Each63629-80147b3f8cdb-db56-4602-859d-bbd8373bdadd12021-01-08
63629-8014-3EA - Each63629-8014d6f0c5d8-170d-4512-8651-465f0728280d12020-06-05
63629-8014-4EA - Each63629-8014e64b386b-f672-4958-aae3-a2e3045baf6212020-02-13
63629-8014-5EA - Each63629-801423a21dc0-2edc-44b8-8571-f7403be5450012021-01-08
63629-8014-7EA - Each63629-8014f5aecf78-2f46-4432-b308-4efa88f361df12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8014METAXALONE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20240726_07ccff59-e335-40be-9e40-fd2d08197617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN07ccff59-e335-40be-9e40-fd2d0819761710
351254metaxalone 800 MG Oral TabletSCD07ccff59-e335-40be-9e40-fd2d0819761710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8014-16362980140130 TABLET in 1 BOTTLE (63629-8014-1) 30 tablet2019-06-180000-00-00NoNoCurrent
63629-8014-26362980140290 TABLET in 1 BOTTLE (63629-8014-2) 90 tablet2019-10-020000-00-00NoNoCurrent
63629-8014-363629801403100 TABLET in 1 BOTTLE (63629-8014-3) 100 tablet2019-12-260000-00-00NoNoCurrent
63629-8014-46362980140460 TABLET in 1 BOTTLE (63629-8014-4) 60 tablet2019-10-220000-00-00NoNoCurrent
63629-8014-56362980140510 TABLET in 1 BOTTLE (63629-8014-5) 10 tablet2020-01-140000-00-00NoNoCurrent
63629-8014-66362980140620 TABLET in 1 BOTTLE (63629-8014-6) 20 tablet2020-02-280000-00-00NoNoCurrent
63629-8014-763629801407120 TABLET in 1 BOTTLE (63629-8014-7) 120 tablet2024-04-11NoNoHistorical
63629-8014-86362980140815 TABLET in 1 BOTTLE (63629-8014-8) 15 tablet2024-04-11NoNoHistorical