FDA.reportPublic FDA data

Modafinil

Product NDC
60505-2527
11-digit product format
605052527
Labeler code
60505
Product ID
60505-2527_a15122ea-67a9-9fc1-51e2-a0b5b0052c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077667
Marketing category
ANDA
Marketing start
2014-02-03
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
60505-2527-0Modafinil10 in 1 BOX, UNIT-DOSETABLET1020
60505-2527-0Modafinil10 in 1 BLISTER PACKTABLET1020
60505-2527-1Modafinil100 in 1 BOTTLETABLET10020
60505-2527-3Modafinil30 in 1 BOTTLETABLET3020
60505-2527-5Modafinil500 in 1 BOTTLETABLET50020
60505-2527-8Modafinil1000 in 1 BOTTLETABLET100020
60505-2527-9Modafinil90 in 1 BOTTLETABLET9020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [APOTEX CORP.]10
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [APOTEX CORP.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [APOTEX CORP.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [APOTEX CORP.]10
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MODAFINIL TABLET [APOTEX CORP.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MODAFINIL TABLET [APOTEX CORP.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2527MODAFINIL TABLET [APOTEX CORP.]19Current NDC, Legacy NDC, 7 package rows20240606_944daf47-49a6-93ca-e348-4a0f1b6d937e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN944daf47-49a6-93ca-e348-4a0f1b6d937e20
205324modafinil 200 MG Oral TabletPSN944daf47-49a6-93ca-e348-4a0f1b6d937e20
260218modafinil 100 MG Oral TabletSCD944daf47-49a6-93ca-e348-4a0f1b6d937e20
205324modafinil 200 MG Oral TabletSCD944daf47-49a6-93ca-e348-4a0f1b6d937e20
260218modafinil 100 MG Oral TabletPSN4a7ab52b-db31-4774-a06a-b11f2bb606624
205324modafinil 200 MG Oral TabletPSN4a7ab52b-db31-4774-a06a-b11f2bb606624
260218modafinil 100 MG Oral TabletSCD4a7ab52b-db31-4774-a06a-b11f2bb606624
205324modafinil 200 MG Oral TabletSCD4a7ab52b-db31-4774-a06a-b11f2bb606624
205324modafinil 200 MG Oral TabletPSNa4a27496-0f5a-4ea8-b48c-72fcb323dc8f2
205324modafinil 200 MG Oral TabletSCDa4a27496-0f5a-4ea8-b48c-72fcb323dc8f2
205324modafinil 200 MG Oral TabletPSN1b228142-f208-44fb-8abe-1adad707b89b1
205324modafinil 200 MG Oral TabletSCD1b228142-f208-44fb-8abe-1adad707b89b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2527-06050525270010 BLISTER PACK in 1 BOX, UNIT-DOSE (60505-2527-0) > 10 TABLET in 1 BLISTER PACK10 blister pack2014-02-030000-00-00NoNoCurrent
60505-2527-160505252701100 TABLET in 1 BOTTLE (60505-2527-1) 100 tablet2021-01-140000-00-00NoNoCurrent
60505-2527-36050525270330 TABLET in 1 BOTTLE (60505-2527-3) 30 tablet2014-02-030000-00-00NoNoCurrent
60505-2527-560505252705500 TABLET in 1 BOTTLE (60505-2527-5) 500 tablet2014-02-030000-00-00NoNoCurrent
60505-2527-8605052527081000 TABLET in 1 BOTTLE (60505-2527-8) 1000 tablet2014-02-030000-00-00NoNoCurrent
60505-2527-96050525270990 TABLET in 1 BOTTLE (60505-2527-9) 90 tablet2014-02-030000-00-00NoNoCurrent