Metaxalone

Product NDC
80175-0472
11-digit product format
801750472
Labeler code
80175
Product ID
80175-0472_be5e1775-8076-dd5d-e053-2995a90a3143
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
Central Packaging
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
2022-12-31
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
80175-0472-9Metaxalone90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0472METAXALONE TABLET [CENTRAL PACKAGING]1Legacy NDC, 1 package rows20210226_bc2cec64-f842-532c-e053-2995a90a554d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNbc2cec64-f842-532c-e053-2995a90a554d1
351254metaxalone 800 MG Oral TabletSCDbc2cec64-f842-532c-e053-2995a90a554d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80175-0472-98017504720990 TABLET in 1 BOTTLE (80175-0472-9) 90 tablet2018-09-240000-00-00NoNoCurrent