Modafinil

Product NDC
0591-3499
11-digit product format
005913499
Labeler code
0591
Product ID
0591-3499_e008554f-9b68-4afd-a091-9087d298497d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076715
Marketing category
ANDA
Marketing start
2013-04-03
Marketing end
2021-11-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3499-01EA - Each0591-3499bd7c4606-0a0a-49e5-b948-c9d39ce6018c12013-05-02
0591-3499-30EA - Each0591-3499f90d137f-4b7d-422c-8c4b-7be26521eabd12013-05-02

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
0591-3499-0100591349901100 TABLET in 1 BOTTLE, PLASTIC (0591-3499-01) 100 tablet2013-04-032021-11-30NoNoCurrent
0591-3499-300059134993030 TABLET in 1 BOTTLE, PLASTIC (0591-3499-30) 30 tablet2013-04-032021-11-30NoNoCurrent