FDA.reportPublic FDA data

Modafinil

Product NDC
72578-005
11-digit product format
725780005
Labeler code
72578
Product ID
72578-005_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
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
72578-005-01Modafinil100 in 1 BOTTLETABLET1005
72578-005-06Modafinil30 in 1 BOTTLETABLET305
72578-005-16Modafinil90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-005-06EA - Each72578-00578e984b4-2f32-4288-a8e9-53cb0fb5a51d12022-08-04
72578-005-16EA - Each72578-0052475b74d-9841-4e35-b39e-b48fe152577c12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-005MODAFINIL 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
260218modafinil 100 MG Oral TabletPSN457662d8-b95c-d3af-e063-6294a90a883e1
260218modafinil 100 MG Oral TabletPSN463bb960-a0b5-4ca4-e063-6294a90a683b1
205324modafinil 200 MG Oral TabletPSN457662d8-b95c-d3af-e063-6294a90a883e1
260218modafinil 100 MG Oral TabletSCD457662d8-b95c-d3af-e063-6294a90a883e1
260218modafinil 100 MG Oral TabletSCD463bb960-a0b5-4ca4-e063-6294a90a683b1
205324modafinil 200 MG Oral TabletSCD457662d8-b95c-d3af-e063-6294a90a883e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-005-0172578000501100 TABLET in 1 BOTTLE (72578-005-01) 100 tablet2019-02-150000-00-00NoNoCurrent
72578-005-067257800050630 TABLET in 1 BOTTLE (72578-005-06) 30 tablet2019-02-150000-00-00NoNoCurrent
72578-005-167257800051690 TABLET in 1 BOTTLE (72578-005-16) 90 tablet2019-02-150000-00-00NoNoCurrent