Modafinil

Product NDC
23155-604
11-digit product format
231550604
Labeler code
23155
Product ID
23155-604_d8fc4961-6cbc-44fc-be5f-63127fff98f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA207196
Marketing category
ANDA
Marketing start
2021-02-18
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
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
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
23155-604-01Modafinil100 in 1 BOTTLE, PLASTICTABLET10013
23155-604-03Modafinil30 in 1 BOTTLE, PLASTICTABLET3013
23155-604-05Modafinil500 in 1 BOTTLE, PLASTICTABLET50013
23155-604-09Modafinil90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-604MODAFINIL TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 4 package rows20240223_1a309416-bd6a-45b1-982f-b689b097453d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN1a309416-bd6a-45b1-982f-b689b097453d13
205324modafinil 200 MG Oral TabletPSN1a309416-bd6a-45b1-982f-b689b097453d13
260218modafinil 100 MG Oral TabletSCD1a309416-bd6a-45b1-982f-b689b097453d13
205324modafinil 200 MG Oral TabletSCD1a309416-bd6a-45b1-982f-b689b097453d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-604-0123155060401100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01) 100 tablet2021-02-180000-00-00NoNoCurrent
23155-604-032315506040330 TABLET in 1 BOTTLE, PLASTIC (23155-604-03) 30 tablet2021-02-180000-00-00NoNoCurrent
23155-604-0523155060405500 TABLET in 1 BOTTLE, PLASTIC (23155-604-05) 500 tablet2021-02-180000-00-00NoNoCurrent
23155-604-092315506040990 TABLET in 1 BOTTLE, PLASTIC (23155-604-09) 90 tablet2021-02-180000-00-00NoNoCurrent