FDA.reportPublic FDA data

Metaxalone

Product NDC
71335-2066
11-digit product format
713352066
Labeler code
71335
Product ID
71335-2066_9774fc12-2fd3-4928-8960-6a211eabfb68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
71335-2066-1Metaxalone30 in 1 BOTTLETABLET30103
71335-2066-2Metaxalone90 in 1 BOTTLETABLET90103
71335-2066-3Metaxalone100 in 1 BOTTLETABLET100103
71335-2066-4Metaxalone60 in 1 BOTTLETABLET60103
71335-2066-5Metaxalone10 in 1 BOTTLETABLET10103
71335-2066-6Metaxalone20 in 1 BOTTLETABLET20103
71335-2066-7Metaxalone120 in 1 BOTTLETABLET120103
71335-2066-8Metaxalone15 in 1 BOTTLETABLET15103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2066-1EA - Each71335-20667dbdf24a-15a9-44c2-b964-c874bc57736812025-09-12
71335-2066-2EA - Each71335-20662dc0e18a-4f06-43e7-a91e-095dd8092b8212025-09-12
71335-2066-4EA - Each71335-20667ab356bd-efbb-4f69-a316-fefc4629859f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2066METAXALONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240828_a662fd07-2896-4cbb-bafc-aa5ab179a148.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNa662fd07-2896-4cbb-bafc-aa5ab179a148103
351254metaxalone 800 MG Oral TabletSCDa662fd07-2896-4cbb-bafc-aa5ab179a148103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2066-17133520660130 TABLET in 1 BOTTLE (71335-2066-1) 30 tablet2023-11-100000-00-00NoNoCurrent
71335-2066-27133520660290 TABLET in 1 BOTTLE (71335-2066-2) 90 tablet2024-04-020000-00-00NoNoCurrent
71335-2066-371335206603100 TABLET in 1 BOTTLE (71335-2066-3) 100 tablet2024-08-120000-00-00NoNoCurrent
71335-2066-47133520660460 TABLET in 1 BOTTLE (71335-2066-4) 60 tablet2022-03-180000-00-00NoNoCurrent
71335-2066-57133520660510 TABLET in 1 BOTTLE (71335-2066-5) 10 tablet2024-08-120000-00-00NoNoCurrent
71335-2066-67133520660620 TABLET in 1 BOTTLE (71335-2066-6) 20 tablet2024-08-120000-00-00NoNoCurrent
71335-2066-771335206607120 TABLET in 1 BOTTLE (71335-2066-7) 120 tablet2024-08-12NoNoHistorical
71335-2066-87133520660815 TABLET in 1 BOTTLE (71335-2066-8) 15 tablet2024-08-12NoNoHistorical