Metaxalone

Product NDC
50090-4448
11-digit product format
500904448
Labeler code
50090
Product ID
50090-4448_8ae0229d-9c4b-4e23-92ff-866924af2b19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metaxalone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207466
Marketing category
ANDA
Marketing start
2017-08-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4448-0Metaxalone30 in 1 BOTTLETABLET305
50090-4448-1Metaxalone60 in 1 BOTTLETABLET605
50090-4448-2Metaxalone15 in 1 BOTTLETABLET155
50090-4448-3Metaxalone20 in 1 BOTTLETABLET205
50090-4448-4Metaxalone10 in 1 BOTTLETABLET105
50090-4448-5Metaxalone100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4448METAXALONE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 6 package rows20210417_b57fcd53-4481-4345-983c-23b7356a69ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351254metaxalone 800 MG Oral TabletPSNb57fcd53-4481-4345-983c-23b7356a69ad5
351254metaxalone 800 MG Oral TabletSCDb57fcd53-4481-4345-983c-23b7356a69ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4448-05009044480030 TABLET in 1 BOTTLE (50090-4448-0) 30 tablet2019-08-050000-00-00NoNoCurrent
50090-4448-15009044480160 TABLET in 1 BOTTLE (50090-4448-1) 60 tablet2019-08-050000-00-00NoNoCurrent
50090-4448-25009044480215 TABLET in 1 BOTTLE (50090-4448-2) 15 tablet2019-08-050000-00-00NoNoCurrent
50090-4448-35009044480320 TABLET in 1 BOTTLE (50090-4448-3) 20 tablet2019-08-050000-00-00NoNoCurrent
50090-4448-45009044480410 TABLET in 1 BOTTLE (50090-4448-4) 10 tablet2019-08-050000-00-00NoNoCurrent
50090-4448-550090444805100 TABLET in 1 BOTTLE (50090-4448-5) 100 tablet2019-08-200000-00-00NoNoCurrent