FDA.reportPublic FDA data

Metaxalone

Product NDC
71335-0958
11-digit product format
713350958
Labeler code
71335
Product ID
71335-0958_d884568c-4c86-428f-958a-16367089c4ad
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
71335-0958-0Metaxalone100 in 1 BOTTLETABLET1007
71335-0958-1Metaxalone30 in 1 BOTTLETABLET307
71335-0958-2Metaxalone20 in 1 BOTTLETABLET207
71335-0958-3Metaxalone90 in 1 BOTTLETABLET907
71335-0958-4Metaxalone120 in 1 BOTTLETABLET1207
71335-0958-5Metaxalone15 in 1 BOTTLETABLET157
71335-0958-6Metaxalone10 in 1 BOTTLETABLET107
71335-0958-7Metaxalone60 in 1 BOTTLETABLET607
71335-0958-8Metaxalone16 in 1 BOTTLETABLET167
71335-0958-9Metaxalone84 in 1 BOTTLETABLET847

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0958-1EA - Each71335-09584930a31a-2410-4788-bab3-bf5ac84ff56712020-09-14
71335-0958-3EA - Each71335-0958e81c0402-7ca6-4447-aee0-d44918d399e112021-12-08
71335-0958-4EA - Each71335-09585405787c-b90f-4e1d-9cd0-26f664fb852812023-06-06
71335-0958-7EA - Each71335-095835ed3c6f-f54a-4364-a0d3-33d2de36692112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0958METAXALONE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240809_7f758053-2367-4c5f-9bbd-ce8ce263a615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN7f758053-2367-4c5f-9bbd-ce8ce263a6157
351254metaxalone 800 MG Oral TabletSCD7f758053-2367-4c5f-9bbd-ce8ce263a6157

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0958-071335095800100 TABLET in 1 BOTTLE (71335-0958-0) 100 tablet2020-05-080000-00-00NoNoCurrent
71335-0958-17133509580130 TABLET in 1 BOTTLE (71335-0958-1) 30 tablet2018-09-270000-00-00NoNoCurrent
71335-0958-27133509580220 TABLET in 1 BOTTLE (71335-0958-2) 20 tablet2019-06-110000-00-00NoNoCurrent
71335-0958-37133509580390 TABLET in 1 BOTTLE (71335-0958-3) 90 tablet2019-03-210000-00-00NoNoCurrent
71335-0958-471335095804120 TABLET in 1 BOTTLE (71335-0958-4) 120 tablet2019-04-010000-00-00NoNoCurrent
71335-0958-57133509580515 TABLET in 1 BOTTLE (71335-0958-5) 15 tablet2021-07-290000-00-00NoNoCurrent
71335-0958-67133509580610 TABLET in 1 BOTTLE (71335-0958-6) 10 tablet2021-01-250000-00-00NoNoCurrent
71335-0958-77133509580760 TABLET in 1 BOTTLE (71335-0958-7) 60 tablet2019-03-120000-00-00NoNoCurrent
71335-0958-87133509580816 TABLET in 1 BOTTLE (71335-0958-8) 16 tablet2021-12-280000-00-00NoNoCurrent
71335-0958-97133509580984 TABLET in 1 BOTTLE (71335-0958-9) 84 tablet2021-12-280000-00-00NoNoCurrent