FDA.reportPublic FDA data

Modafinil

Product NDC
71610-685
11-digit product format
716100685
Labeler code
71610
Product ID
71610-685_e12198af-3556-407d-bac7-29b6ea6cc45f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077667
Marketing category
ANDA
Marketing start
2014-02-03
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
71610-685-30Modafinil30 in 1 BOTTLETABLET302
71610-685-53Modafinil60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-685-53EA - Each71610-685e57707cd-fdc1-4bf4-adf7-ead6ee13d90712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-685MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 2 package rows20230117_a4a27496-0f5a-4ea8-b48c-72fcb323dc8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSNa4a27496-0f5a-4ea8-b48c-72fcb323dc8f2
205324modafinil 200 MG Oral TabletSCDa4a27496-0f5a-4ea8-b48c-72fcb323dc8f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-685-307161006853030 TABLET in 1 BOTTLE (71610-685-30) 30 tablet2023-01-11NoNoCurrent
71610-685-537161006855360 TABLET in 1 BOTTLE (71610-685-53) 60 tablet2023-01-11NoNoCurrent