FDA.reportPublic FDA data

Modafinil

Product NDC
55253-801
11-digit product format
552530801
Labeler code
55253
Product ID
55253-801_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
2027-03-31
Substance
MODAFINIL
Active strength
100 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
MODAFINIL100 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
55253-801-30Modafinil30 in 1 BOTTLETABLET3020
55253-801-90Modafinil90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55253-801-30EA - Each55253-8018bad5db7-d8e6-4bfe-86a6-22fc4482753112012-07-24
55253-801-90EA - Each55253-8019e9493f2-a776-4fc8-8cb5-ef9a4b9ed27912012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55253-801MODAFINIL 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55253-801-305525308013030 TABLET in 1 BOTTLE (55253-801-30) 30 tablet2012-03-292027-03-31NoNoCurrent
55253-801-905525308019090 TABLET in 1 BOTTLE (55253-801-90) 90 tablet2012-03-290000-00-00NoNoCurrent