FDA.reportPublic FDA data

Modafinil

Product NDC
62332-385
11-digit product format
623320385
Labeler code
62332
Product ID
62332-385_7aa21a37-6c25-44ce-869c-c1b2309398bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202700
Marketing category
ANDA
Marketing start
2017-06-30
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-385-10Modafinil100 in 1 CARTONTABLET1007
62332-385-30Modafinil30 in 1 BOTTLETABLET307
62332-385-60Modafinil60 in 1 BOTTLETABLET607
62332-385-90Modafinil90 in 1 BOTTLETABLET907
62332-385-91Modafinil1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-385-30EA - Each62332-385ad11580a-fd59-4632-a458-111d73b4702512017-08-11
62332-385-90EA - Each62332-38500e02e05-5141-421b-8794-18206ca7c93612017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-385MODAFINIL TABLET [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 5 package rows20211003_41f9ddbd-5228-4f0c-b0aa-2056af79a21e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN41f9ddbd-5228-4f0c-b0aa-2056af79a21e7
205324modafinil 200 MG Oral TabletPSN41f9ddbd-5228-4f0c-b0aa-2056af79a21e7
260218modafinil 100 MG Oral TabletSCD41f9ddbd-5228-4f0c-b0aa-2056af79a21e7
205324modafinil 200 MG Oral TabletSCD41f9ddbd-5228-4f0c-b0aa-2056af79a21e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-385-1062332038510100 TABLET in 1 CARTON (62332-385-10) 100 tablet2017-06-300000-00-00NoNoCurrent
62332-385-306233203853030 TABLET in 1 BOTTLE (62332-385-30) 30 tablet2017-06-300000-00-00NoNoCurrent
62332-385-606233203856060 TABLET in 1 BOTTLE (62332-385-60) 60 tablet2017-06-300000-00-00NoNoCurrent
62332-385-906233203859090 TABLET in 1 BOTTLE (62332-385-90) 90 tablet2017-06-300000-00-00NoNoCurrent
62332-385-91623320385911000 TABLET in 1 BOTTLE (62332-385-91) 1000 tablet2017-06-300000-00-00NoNoCurrent