FDA.reportPublic FDA data

Modafinil

Product NDC
65862-602
11-digit product format
658620602
Labeler code
65862
Product ID
65862-602_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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, 260218

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
65862-602-01Modafinil100 in 1 BOTTLETABLET10011
65862-602-05Modafinil500 in 1 BOTTLETABLET50011
65862-602-30Modafinil30 in 1 BOTTLETABLET3011
65862-602-90Modafinil90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-602-01EA - Each65862-602fa40edf6-1361-4394-a371-baefc0b75c3b12013-02-13
65862-602-30EA - Each65862-60283cfa635-dd42-40d4-a96d-3a9c51d5f98812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMODAFINIL TABLET [AUROBINDO PHARMA LIMITED]4
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-602MODAFINIL TABLET [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 4 package rows20240529_f51ca007-3955-4540-a88a-0ddae8d8e8ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN928a3ab6-b53c-4924-882c-9f2f49aba0f111
260218modafinil 100 MG Oral TabletPSNf51ca007-3955-4540-a88a-0ddae8d8e8ab11
205324modafinil 200 MG Oral TabletPSN928a3ab6-b53c-4924-882c-9f2f49aba0f111
205324modafinil 200 MG Oral TabletPSNf51ca007-3955-4540-a88a-0ddae8d8e8ab11
260218modafinil 100 MG Oral TabletSCD928a3ab6-b53c-4924-882c-9f2f49aba0f111
260218modafinil 100 MG Oral TabletSCDf51ca007-3955-4540-a88a-0ddae8d8e8ab11
205324modafinil 200 MG Oral TabletSCD928a3ab6-b53c-4924-882c-9f2f49aba0f111
205324modafinil 200 MG Oral TabletSCDf51ca007-3955-4540-a88a-0ddae8d8e8ab11
205324modafinil 200 MG Oral TabletPSNf0c43046-fc86-4b62-bd0f-704a6894625d10
205324modafinil 200 MG Oral TabletSCDf0c43046-fc86-4b62-bd0f-704a6894625d10
260218modafinil 100 MG Oral TabletPSN4790bbe9-d753-1067-02ee-9536011650d96
205324modafinil 200 MG Oral TabletPSN4790bbe9-d753-1067-02ee-9536011650d96
260218modafinil 100 MG Oral TabletSCD4790bbe9-d753-1067-02ee-9536011650d96
205324modafinil 200 MG Oral TabletSCD4790bbe9-d753-1067-02ee-9536011650d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-602-0165862060201100 TABLET in 1 BOTTLE (65862-602-01) 100 tablet2012-09-270000-00-00NoNoCurrent
65862-602-0565862060205500 TABLET in 1 BOTTLE (65862-602-05) 500 tablet2012-09-270000-00-00NoNoCurrent
65862-602-306586206023030 TABLET in 1 BOTTLE (65862-602-30) 30 tablet2012-09-270000-00-00NoNoCurrent
65862-602-906586206029090 TABLET in 1 BOTTLE (65862-602-90) 90 tablet2012-09-270000-00-00NoNoCurrent