FDA.reportPublic FDA data

Modafinil

Product NDC
72578-006
11-digit product format
725780006
Labeler code
72578
Product ID
72578-006_452d2687-49ff-4734-8799-a4a5264cc584
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA209966
Marketing category
ANDA
Marketing start
2019-02-15
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, 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
72578-006-01Modafinil100 in 1 BOTTLETABLET1005
72578-006-06Modafinil30 in 1 BOTTLETABLET305
72578-006-16Modafinil90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-006-01EA - Each72578-006e08ae26b-766d-4c21-a2f9-5f79d0a67a8612022-08-04
72578-006-06EA - Each72578-0065a60d051-216b-48cf-8165-61965c1bb00912022-08-04
72578-006-16EA - Each72578-006ea4dcf8b-8900-4309-bfac-4c037e53197912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-006MODAFINIL TABLET [VIONA PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 3 package rows20231121_15739a31-2433-49b5-90ea-b974214f73be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN15739a31-2433-49b5-90ea-b974214f73be5
205324modafinil 200 MG Oral TabletPSN15739a31-2433-49b5-90ea-b974214f73be5
260218modafinil 100 MG Oral TabletSCD15739a31-2433-49b5-90ea-b974214f73be5
205324modafinil 200 MG Oral TabletSCD15739a31-2433-49b5-90ea-b974214f73be5
205324modafinil 200 MG Oral TabletPSN2bc3cd03-2726-f693-e063-6294a90a7a032
205324modafinil 200 MG Oral TabletSCD2bc3cd03-2726-f693-e063-6294a90a7a032
260218modafinil 100 MG Oral TabletPSN457662d8-b95c-d3af-e063-6294a90a883e1
205324modafinil 200 MG Oral TabletPSN457662d8-b95c-d3af-e063-6294a90a883e1
205324modafinil 200 MG Oral TabletPSNc332ea93-48d9-4c8a-a1ef-01c27a61350b1
260218modafinil 100 MG Oral TabletSCD457662d8-b95c-d3af-e063-6294a90a883e1
205324modafinil 200 MG Oral TabletSCD457662d8-b95c-d3af-e063-6294a90a883e1
205324modafinil 200 MG Oral TabletSCDc332ea93-48d9-4c8a-a1ef-01c27a61350b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-006-0172578000601100 TABLET in 1 BOTTLE (72578-006-01) 100 tablet2019-02-150000-00-00NoNoCurrent
72578-006-067257800060630 TABLET in 1 BOTTLE (72578-006-06) 30 tablet2019-02-150000-00-00NoNoCurrent
72578-006-167257800061690 TABLET in 1 BOTTLE (72578-006-16) 90 tablet2019-02-150000-00-00NoNoCurrent