FDA.reportPublic FDA data

Modafinil

Product NDC
68788-8653
11-digit product format
687888653
Labeler code
68788
Product ID
68788-8653_7cd7e2ce-ecdf-4660-93e9-ee86e985d0a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207196
Marketing category
ANDA
Marketing start
2024-05-09
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
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8653-3Modafinil30 in 1 BOTTLETABLET302
68788-8653-6Modafinil60 in 1 BOTTLETABLET602
68788-8653-9Modafinil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8653-3EA - Each68788-86539176806f-db70-47db-a1d4-9878dd930a7d12024-06-10
68788-8653-6EA - Each68788-8653d48e7187-32cd-4749-a328-537c44279ebc12024-06-10
68788-8653-9EA - Each68788-86538e142eb3-8996-42cc-a807-1ccaddbc0c2112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8653MODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240531_60ec6e2a-2576-498f-9a8c-fddc53d4a44c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN60ec6e2a-2576-498f-9a8c-fddc53d4a44c2
205324modafinil 200 MG Oral TabletSCD60ec6e2a-2576-498f-9a8c-fddc53d4a44c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8653-36878886530330 TABLET in 1 BOTTLE (68788-8653-3) 30 tablet2024-05-09NoNoCurrent
68788-8653-66878886530660 TABLET in 1 BOTTLE (68788-8653-6) 60 tablet2024-05-09NoNoCurrent
68788-8653-96878886530990 TABLET in 1 BOTTLE (68788-8653-9) 90 tablet2024-05-09NoNoCurrent