Modafinil

Product NDC
50090-3865
11-digit product format
500903865
Labeler code
50090
Product ID
50090-3865_8b9a56d0-803d-4664-825f-ddbaabe75bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076715
Marketing category
ANDA
Marketing start
2013-04-03
Marketing end
0000-00-00
Substance
MODAFINIL
Active strength
100 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
50090-3865-0Modafinil30 in 1 BOTTLETABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3865MODAFINIL TABLET [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20190103_d2558a46-b482-494c-9d86-f883dc30f14b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSNd2558a46-b482-494c-9d86-f883dc30f14b7
260218modafinil 100 MG Oral TabletSCDd2558a46-b482-494c-9d86-f883dc30f14b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3865-05009038650030 TABLET in 1 BOTTLE (50090-3865-0) 30 tablet2018-11-260000-00-00NoNoCurrent