FDA.reportPublic FDA data

Modafinil

Product NDC
71610-873
11-digit product format
716100873
Labeler code
71610
Product ID
71610-873_2eaa44b1-463c-4195-e063-6294a90a0e60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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

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
71610-873-30Modafinil30 in 1 BOTTLETABLET302
71610-873-53Modafinil60 in 1 BOTTLETABLET602
71610-873-60Modafinil90 in 1 BOTTLETABLET902
71610-873-80Modafinil180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-873-30EA - Each71610-873ca63cd1c-7f8d-4453-90e4-07440048423c12025-05-14
71610-873-53EA - Each71610-8730f14aa4e-bd3d-45a2-91ba-e5cc1489c6eb12025-03-04
71610-873-60EA - Each71610-87323fed541-8004-493b-96a2-2ce30915a9f912025-05-14
71610-873-80EA - Each71610-873438dfc9e-e152-4a8d-aafa-87176b5e948e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-873MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 4 package rows20250224_2bc3cd03-2726-f693-e063-6294a90a7a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN2bc3cd03-2726-f693-e063-6294a90a7a032
205324modafinil 200 MG Oral TabletSCD2bc3cd03-2726-f693-e063-6294a90a7a032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-873-307161008733030 TABLET in 1 BOTTLE (71610-873-30) 30 tablet2025-02-20NoNoCurrent
71610-873-537161008735360 TABLET in 1 BOTTLE (71610-873-53) 60 tablet2025-01-13NoNoCurrent
71610-873-607161008736090 TABLET in 1 BOTTLE (71610-873-60) 90 tablet2025-02-20NoNoCurrent
71610-873-8071610087380180 TABLET in 1 BOTTLE (71610-873-80) 180 tablet2025-02-20NoNoCurrent