Modafinil

Product NDC
71335-1173
11-digit product format
713351173
Labeler code
71335
Product ID
71335-1173_de9428af-1cab-488e-9449-c481656e5a71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202566
Marketing category
ANDA
Marketing start
2012-09-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Modafinil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MODAFINIL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR3UK8X3U3D
Rxcui205324

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
71335-1173-0Modafinil100 in 1 BOTTLETABLET100104
71335-1173-1Modafinil30 in 1 BOTTLETABLET30104
71335-1173-2Modafinil18 in 1 BOTTLETABLET18104
71335-1173-3Modafinil16 in 1 BOTTLETABLET16104
71335-1173-4Modafinil8 in 1 BOTTLETABLET8104
71335-1173-5Modafinil10 in 1 BOTTLETABLET10104
71335-1173-6Modafinil60 in 1 BOTTLETABLET60104
71335-1173-7Modafinil90 in 1 BOTTLETABLET90104
71335-1173-8Modafinil45 in 1 BOTTLETABLET45104
71335-1173-9Modafinil180 in 1 BOTTLETABLET180104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1173MODAFINIL TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240829_963aa6be-5aed-4865-b375-8c2c3102e7bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN963aa6be-5aed-4865-b375-8c2c3102e7bc104
205324modafinil 200 MG Oral TabletSCD963aa6be-5aed-4865-b375-8c2c3102e7bc104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1173-071335117300100 TABLET in 1 BOTTLE (71335-1173-0) 100 tablet2024-07-09NoNoHistorical
71335-1173-17133511730130 TABLET in 1 BOTTLE (71335-1173-1) 30 tablet2019-04-020000-00-00NoNoCurrent
71335-1173-27133511730218 TABLET in 1 BOTTLE (71335-1173-2) 18 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-37133511730316 TABLET in 1 BOTTLE (71335-1173-3) 16 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-4713351173048 TABLET in 1 BOTTLE (71335-1173-4) 8 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-57133511730510 TABLET in 1 BOTTLE (71335-1173-5) 10 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-67133511730660 TABLET in 1 BOTTLE (71335-1173-6) 60 tablet2019-06-050000-00-00NoNoCurrent
71335-1173-77133511730790 TABLET in 1 BOTTLE (71335-1173-7) 90 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-87133511730845 TABLET in 1 BOTTLE (71335-1173-8) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-1173-971335117309180 TABLET in 1 BOTTLE (71335-1173-9) 180 tablet2024-07-090000-00-00NoNoCurrent