Metaxalone

Product NDC
71335-1320
11-digit product format
713351320
Labeler code
71335
Product ID
71335-1320_dca96205-b555-4433-a277-356e07fdfdb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208774
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
METAXALONE
Active strength
800 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
71335-1320-0Metaxalone100 in 1 BOTTLETABLET1002
71335-1320-1Metaxalone30 in 1 BOTTLETABLET302
71335-1320-2Metaxalone20 in 1 BOTTLETABLET202
71335-1320-3Metaxalone90 in 1 BOTTLETABLET902
71335-1320-4Metaxalone120 in 1 BOTTLETABLET1202
71335-1320-5Metaxalone15 in 1 BOTTLETABLET152
71335-1320-6Metaxalone10 in 1 BOTTLETABLET102
71335-1320-7Metaxalone60 in 1 BOTTLETABLET602
71335-1320-8Metaxalone16 in 1 BOTTLETABLET162
71335-1320-9Metaxalone84 in 1 BOTTLETABLET842

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1320-1EA - Each71335-132053f2e65b-9076-46af-80b0-890b7a5dbcf212021-08-05
71335-1320-3EA - Each71335-132051a322a3-e5d8-465c-8294-27c7fb2eada912021-08-05
71335-1320-7EA - Each71335-13207f873e36-6c79-40a8-968c-88e173a1a59b12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1320METAXALONE TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 10 package rows20231116_7cd2c31c-adf9-459f-9c52-7bbc5639767f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN7cd2c31c-adf9-459f-9c52-7bbc5639767f2
351254metaxalone 800 MG Oral TabletSCD7cd2c31c-adf9-459f-9c52-7bbc5639767f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1320-071335132000100 TABLET in 1 BOTTLE (71335-1320-0) 100 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-17133513200130 TABLET in 1 BOTTLE (71335-1320-1) 30 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-27133513200220 TABLET in 1 BOTTLE (71335-1320-2) 20 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-37133513200390 TABLET in 1 BOTTLE (71335-1320-3) 90 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-471335132004120 TABLET in 1 BOTTLE (71335-1320-4) 120 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-57133513200515 TABLET in 1 BOTTLE (71335-1320-5) 15 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-67133513200610 TABLET in 1 BOTTLE (71335-1320-6) 10 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-77133513200760 TABLET in 1 BOTTLE (71335-1320-7) 60 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-87133513200816 TABLET in 1 BOTTLE (71335-1320-8) 16 tablet2019-08-290000-00-00NoNoCurrent
71335-1320-97133513200984 TABLET in 1 BOTTLE (71335-1320-9) 84 tablet2019-08-290000-00-00NoNoCurrent