METAXALONE

Product NDC
61919-091
11-digit product format
619190091
Labeler code
61919
Product ID
61919-091_87fdca26-e05b-053b-e053-2995a90acfa2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METAXALONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040445
Marketing category
ANDA
Marketing start
2017-02-22
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
61919-091-30METAXALONE30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-091METAXALONE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20240110_49250bbf-fbfe-07cd-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSN49250bbf-fbfe-07cd-e054-00144ff88e884
351254metaxalone 800 MG Oral TabletSCD49250bbf-fbfe-07cd-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-091-306191900913030 TABLET in 1 BOTTLE (61919-091-30) 30 tablet2017-02-220000-00-00NoNoCurrent