FDA.reportPublic FDA data

Modafinil

Product NDC
68084-621
11-digit product format
680840621
Labeler code
68084
Product ID
68084-621_25c5e078-ef5a-651d-e063-6394a90a2845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA202566
Marketing category
ANDA
Marketing start
2013-06-03
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
68084-621-11Modafinil1 in 1 BLISTER PACKTABLET111
68084-621-21Modafinil30 in 1 BOX, UNIT-DOSETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-621-11EA - Each68084-6213826800f-6b7f-48df-9d77-ea6a10d90a9312013-07-02
68084-621-21EA - Each68084-62101e54d53-1838-479d-a0c5-6d104d3e311912013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MODAFINILACTIVE INGREDIENTR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MODAFINILACTIVE MOIETYR3UK8X3U3DMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMODAFINIL TABLET [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-621MODAFINIL TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241102_928a3ab6-b53c-4924-882c-9f2f49aba0f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN928a3ab6-b53c-4924-882c-9f2f49aba0f111
205324modafinil 200 MG Oral TabletPSN928a3ab6-b53c-4924-882c-9f2f49aba0f111
260218modafinil 100 MG Oral TabletSCD928a3ab6-b53c-4924-882c-9f2f49aba0f111
205324modafinil 200 MG Oral TabletSCD928a3ab6-b53c-4924-882c-9f2f49aba0f111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-621-11680840621111 in 1 BLISTER PACKHistorical
68084-621-216808406212130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-621-21) / 1 TABLET in 1 BLISTER PACK (68084-621-11) 30 blister pack2013-06-030000-00-00NoNoCurrent