FDA.reportPublic FDA data

Modafinil

Product NDC
55253-802
11-digit product format
552530802
Labeler code
55253
Product ID
55253-802_428b6de2-f791-43db-a186-d19312a348fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
CIMA LABS INC.
Application
NDA020717
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-03-29
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Modafinil

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
55253-802-30Modafinil30 in 1 BOTTLETABLET3020
55253-802-90Modafinil90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55253-802-30EA - Each55253-8023cc6aac6-c1ea-491a-8781-24218ebc831c12012-07-24
55253-802-90EA - Each55253-802c82da4c2-4fc6-41c9-b738-a22c267aed1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [CIMA LABS INC.]2
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [CIMA LABS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [CIMA LABS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [CIMA LABS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [CIMA LABS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [CIMA LABS INC.]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQMODAFINIL TABLET [CIMA LABS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMODAFINIL TABLET [CIMA LABS INC.]2
modafinilACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
modafinilACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
modafinilACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
modafinilACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
povidoneINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
povidoneINACTIVE INGREDIENTFZ989GH94EMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMODAFINIL TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55253-802MODAFINIL TABLET [CIMA LABS INC.]20Current NDC, Legacy NDC, 2 package rows20240229_9f3b0bd2-72a3-411f-aeec-b533373f1a97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN9f3b0bd2-72a3-411f-aeec-b533373f1a9720
205324modafinil 200 MG Oral TabletPSN9f3b0bd2-72a3-411f-aeec-b533373f1a9720
260218modafinil 100 MG Oral TabletSCD9f3b0bd2-72a3-411f-aeec-b533373f1a9720
205324modafinil 200 MG Oral TabletSCD9f3b0bd2-72a3-411f-aeec-b533373f1a9720
205324modafinil 200 MG Oral TabletPSNcad4201c-133c-4a61-9d93-3c5e516954302
205324modafinil 200 MG Oral TabletSCDcad4201c-133c-4a61-9d93-3c5e516954302
205324modafinil 200 MG Oral TabletPSNca740635-df30-46af-9202-55af9204f3811
205324modafinil 200 MG Oral TabletSCDca740635-df30-46af-9202-55af9204f3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55253-802-305525308023030 TABLET in 1 BOTTLE (55253-802-30) 30 tablet2012-03-292026-06-30NoNoCurrent
55253-802-905525308029090 TABLET in 1 BOTTLE (55253-802-90) 90 tablet2012-03-292027-02-28NoNoCurrent