FDA.reportPublic FDA data

Modafinil

Product NDC
71205-544
11-digit product format
712050544
Labeler code
71205
Product ID
71205-544_4ecc62bd-49b3-4202-bf5c-91b49c4c2923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202566
Marketing category
ANDA
Marketing start
2012-09-27
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
71205-544-30Modafinil30 in 1 BOTTLETABLET302
71205-544-60Modafinil60 in 1 BOTTLETABLET602
71205-544-90Modafinil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-544-30EA - Each71205-544c445973f-8656-4a19-9dcf-9fa3d9a891ba12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-544MODAFINIL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20230623_d97684d7-c236-451e-99bd-b8df4bf36643.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSNd97684d7-c236-451e-99bd-b8df4bf366432
205324modafinil 200 MG Oral TabletSCDd97684d7-c236-451e-99bd-b8df4bf366432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-544-307120505443030 TABLET in 1 BOTTLE (71205-544-30) 30 tablet2021-03-160000-00-00NoNoCurrent
71205-544-607120505446060 TABLET in 1 BOTTLE (71205-544-60) 60 tablet2021-03-160000-00-00NoNoCurrent
71205-544-907120505449090 TABLET in 1 BOTTLE (71205-544-90) 90 tablet2021-03-160000-00-00NoNoCurrent