FDA.reportPublic FDA data

Modafinil

Product NDC
68788-8280
11-digit product format
687888280
Labeler code
68788
Product ID
68788-8280_a6082200-e30e-47ae-a6dd-d6a83ce1c60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078963
Marketing category
ANDA
Marketing start
2022-11-03
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8280-3Modafinil30 in 1 BOTTLE, PLASTICTABLET303
68788-8280-6Modafinil60 in 1 BOTTLE, PLASTICTABLET603
68788-8280-9Modafinil90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8280-3EA - Each68788-82807f8487f7-a759-423c-8ca2-1d451002368412023-01-09
68788-8280-6EA - Each68788-82806a50fb2e-f962-4157-ab06-619c5bc46fe612023-01-09
68788-8280-9EA - Each68788-828053b97bb7-d4aa-44a8-b69e-a6384f6faa8a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8280MODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20250117_013450dd-cd42-46c7-98d6-9a2925761978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN013450dd-cd42-46c7-98d6-9a29257619783
205324modafinil 200 MG Oral TabletSCD013450dd-cd42-46c7-98d6-9a29257619783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8280-36878882800330 TABLET in 1 BOTTLE, PLASTIC (68788-8280-3) 30 tablet2022-11-030000-00-00NoNoCurrent
68788-8280-66878882800660 TABLET in 1 BOTTLE, PLASTIC (68788-8280-6) 60 tablet2022-11-030000-00-00NoNoCurrent
68788-8280-96878882800990 TABLET in 1 BOTTLE, PLASTIC (68788-8280-9) 90 tablet2022-11-030000-00-00NoNoCurrent