FDA.reportPublic FDA data

Modafinil

Product NDC
71335-2258
11-digit product format
713352258
Labeler code
71335
Product ID
71335-2258_1edff16c-5323-43d1-9896-dfc4a4ebf243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207196
Marketing category
ANDA
Marketing start
2021-02-18
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
71335-2258-0Modafinil100 in 1 BOTTLETABLET100101
71335-2258-1Modafinil30 in 1 BOTTLETABLET30101
71335-2258-2Modafinil18 in 1 BOTTLETABLET18101
71335-2258-3Modafinil16 in 1 BOTTLETABLET16101
71335-2258-4Modafinil8 in 1 BOTTLETABLET8101
71335-2258-5Modafinil10 in 1 BOTTLETABLET10101
71335-2258-6Modafinil60 in 1 BOTTLETABLET60101
71335-2258-7Modafinil90 in 1 BOTTLETABLET90101
71335-2258-8Modafinil45 in 1 BOTTLETABLET45101
71335-2258-9Modafinil180 in 1 BOTTLETABLET180101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2258-1EA - Each71335-22583d4618d9-116d-4765-ad25-7fe8b4cdf58012025-05-14
71335-2258-6EA - Each71335-22588437e3b4-f518-4d89-82fe-4b4a59e2289e12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2258MODAFINIL TABLET [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20240423_dd1454b3-8599-4dfa-aaf7-b8a3ebe85acd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSNdd1454b3-8599-4dfa-aaf7-b8a3ebe85acd101
205324modafinil 200 MG Oral TabletSCDdd1454b3-8599-4dfa-aaf7-b8a3ebe85acd101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2258-071335225800100 TABLET in 1 BOTTLE (71335-2258-0) 100 tablet2024-04-03NoNoHistorical
71335-2258-17133522580130 TABLET in 1 BOTTLE (71335-2258-1) 30 tablet2023-11-02NoNoHistorical
71335-2258-27133522580218 TABLET in 1 BOTTLE (71335-2258-2) 18 tablet2024-04-03NoNoHistorical
71335-2258-37133522580316 TABLET in 1 BOTTLE (71335-2258-3) 16 tablet2024-04-03NoNoHistorical
71335-2258-4713352258048 TABLET in 1 BOTTLE (71335-2258-4) 8 tablet2024-04-03NoNoHistorical
71335-2258-57133522580510 TABLET in 1 BOTTLE (71335-2258-5) 10 tablet2024-04-03NoNoHistorical
71335-2258-67133522580660 TABLET in 1 BOTTLE (71335-2258-6) 60 tablet2023-10-26NoNoHistorical
71335-2258-77133522580790 TABLET in 1 BOTTLE (71335-2258-7) 90 tablet2024-04-03NoNoHistorical
71335-2258-87133522580845 TABLET in 1 BOTTLE (71335-2258-8) 45 tablet2024-04-03NoNoHistorical
71335-2258-971335225809180 TABLET in 1 BOTTLE (71335-2258-9) 180 tablet2024-04-03NoNoHistorical