Modafinil

Product NDC
71335-1402
11-digit product format
713351402
Labeler code
71335
Product ID
71335-1402_7e642144-a267-40b2-8684-a2cfbb7acc5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078963
Marketing category
ANDA
Marketing start
2013-08-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1402-1Modafinil30 in 1 BOTTLETABLET303
71335-1402-2Modafinil18 in 1 BOTTLETABLET183
71335-1402-3Modafinil16 in 1 BOTTLETABLET163
71335-1402-4Modafinil8 in 1 BOTTLETABLET83
71335-1402-5Modafinil10 in 1 BOTTLETABLET103
71335-1402-6Modafinil60 in 1 BOTTLETABLET603
71335-1402-7Modafinil90 in 1 BOTTLETABLET903
71335-1402-8Modafinil45 in 1 BOTTLETABLET453
71335-1402-9Modafinil180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1402-1EA - Each71335-14023fae7938-82d7-4fd5-b0e3-4c44b289bcc112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1402MODAFINIL TABLET [BRYANT RANCH PREPACK]3Legacy NDC, 9 package rows20231118_7e642144-a267-40b2-8684-a2cfbb7acc5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN7e642144-a267-40b2-8684-a2cfbb7acc5f3
205324modafinil 200 MG Oral TabletSCD7e642144-a267-40b2-8684-a2cfbb7acc5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1402-17133514020130 TABLET in 1 BOTTLE (71335-1402-1) 30 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-27133514020218 TABLET in 1 BOTTLE (71335-1402-2) 18 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-37133514020316 TABLET in 1 BOTTLE (71335-1402-3) 16 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-4713351402048 TABLET in 1 BOTTLE (71335-1402-4) 8 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-57133514020510 TABLET in 1 BOTTLE (71335-1402-5) 10 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-67133514020660 TABLET in 1 BOTTLE (71335-1402-6) 60 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-77133514020790 TABLET in 1 BOTTLE (71335-1402-7) 90 tablet2019-11-180000-00-00NoNoCurrent
71335-1402-87133514020845 TABLET in 1 BOTTLE (71335-1402-8) 45 tablet2022-02-140000-00-00NoNoCurrent
71335-1402-971335140209180 TABLET in 1 BOTTLE (71335-1402-9) 180 tablet2022-02-140000-00-00NoNoCurrent