Modafinil

Product NDC
50090-4144
11-digit product format
500904144
Labeler code
50090
Product ID
50090-4144_f4ac9961-cccd-4838-8612-361b4084bafd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
modafinil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077667
Marketing category
ANDA
Marketing start
2014-02-03
Marketing end
0000-00-00
Substance
MODAFINIL
Active strength
200 mg/1
Pharmacologic classes
Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule
CIV
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
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4144-0Modafinil30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4144MODAFINIL TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190220_1b228142-f208-44fb-8abe-1adad707b89b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN1b228142-f208-44fb-8abe-1adad707b89b1
205324modafinil 200 MG Oral TabletSCD1b228142-f208-44fb-8abe-1adad707b89b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4144-05009041440030 TABLET in 1 BOTTLE (50090-4144-0) 30 tablet2019-02-140000-00-00NoNoCurrent