Modafinil

Product NDC
71335-1122
11-digit product format
713351122
Labeler code
71335
Product ID
71335-1122_0c6f0c70-8e9e-4d04-bd7d-88bc33255611
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
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
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
MODAFINIL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR3UK8X3U3D
Rxcui260218

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
71335-1122-1Modafinil30 in 1 BOTTLETABLET308
71335-1122-2Modafinil60 in 1 BOTTLETABLET608
71335-1122-3Modafinil28 in 1 BOTTLETABLET288
71335-1122-4Modafinil90 in 1 BOTTLETABLET908
71335-1122-5Modafinil45 in 1 BOTTLETABLET458
71335-1122-6Modafinil180 in 1 BOTTLETABLET1808
71335-1122-7Modafinil100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1122MODAFINIL TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240724_f1ff7c6d-df04-48dd-a971-454d38e7d997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSNf1ff7c6d-df04-48dd-a971-454d38e7d9978
260218modafinil 100 MG Oral TabletSCDf1ff7c6d-df04-48dd-a971-454d38e7d9978

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1122-17133511220130 TABLET in 1 BOTTLE (71335-1122-1) 30 tablet2019-02-260000-00-00NoNoCurrent
71335-1122-27133511220260 TABLET in 1 BOTTLE (71335-1122-2) 60 tablet2019-03-140000-00-00NoNoCurrent
71335-1122-37133511220328 TABLET in 1 BOTTLE (71335-1122-3) 28 tablet2019-03-140000-00-00NoNoCurrent
71335-1122-47133511220490 TABLET in 1 BOTTLE (71335-1122-4) 90 tablet2019-03-140000-00-00NoNoCurrent
71335-1122-57133511220545 TABLET in 1 BOTTLE (71335-1122-5) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-1122-671335112206180 TABLET in 1 BOTTLE (71335-1122-6) 180 tablet2024-07-090000-00-00NoNoCurrent
71335-1122-771335112207100 TABLET in 1 BOTTLE (71335-1122-7) 100 tablet2022-12-12NoNoCurrent