FDA.reportPublic FDA data

Modafinil

Product NDC
63629-7315
11-digit product format
636297315
Labeler code
63629
Product ID
63629-7315_30de185f-afb7-4999-8903-27eed51ad246
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7315-12024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-22024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-32024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-42024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-52024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-62024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-72024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-82024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-92024-07-22C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-12024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-22024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-32024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-42024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-52024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-62024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-72024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-82024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
63629-7315-92024-01-30C16284748780-11030e365-09a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7315-0Modafinil100 in 1 BOTTLETABLET10010
63629-7315-1Modafinil30 in 1 BOTTLETABLET3010
63629-7315-2Modafinil18 in 1 BOTTLETABLET1810
63629-7315-3Modafinil16 in 1 BOTTLETABLET1610
63629-7315-4Modafinil8 in 1 BOTTLETABLET810
63629-7315-5Modafinil10 in 1 BOTTLETABLET1010
63629-7315-6Modafinil60 in 1 BOTTLETABLET6010
63629-7315-7Modafinil90 in 1 BOTTLETABLET9010
63629-7315-8Modafinil45 in 1 BOTTLETABLET4510
63629-7315-9Modafinil180 in 1 BOTTLETABLET18010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7315MODAFINIL TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240724_f0c43046-fc86-4b62-bd0f-704a6894625d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSNf0c43046-fc86-4b62-bd0f-704a6894625d10
205324modafinil 200 MG Oral TabletSCDf0c43046-fc86-4b62-bd0f-704a6894625d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7315-063629731500100 TABLET in 1 BOTTLE (63629-7315-0) 100 tablet2024-07-08NoNoCurrent
63629-7315-16362973150130 TABLET in 1 BOTTLE (63629-7315-1) 30 tablet2017-06-260000-00-00NoNoCurrent
63629-7315-26362973150218 TABLET in 1 BOTTLE (63629-7315-2) 18 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-36362973150316 TABLET in 1 BOTTLE (63629-7315-3) 16 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-4636297315048 TABLET in 1 BOTTLE (63629-7315-4) 8 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-56362973150510 TABLET in 1 BOTTLE (63629-7315-5) 10 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-66362973150660 TABLET in 1 BOTTLE (63629-7315-6) 60 tablet2018-10-180000-00-00NoNoCurrent
63629-7315-76362973150790 TABLET in 1 BOTTLE (63629-7315-7) 90 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-86362973150845 TABLET in 1 BOTTLE (63629-7315-8) 45 tablet2024-07-080000-00-00NoNoCurrent
63629-7315-963629731509180 TABLET in 1 BOTTLE (63629-7315-9) 180 tablet2024-07-080000-00-00NoNoCurrent