FDA.reportPublic FDA data

Modafinil

Product NDC
50268-571
11-digit product format
502680571
Labeler code
50268
Product ID
50268-571_47e7afcc-7429-1e31-e063-6394a90ab335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA202566
Marketing category
ANDA
Marketing start
2016-08-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Modafinil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MODAFINIL200 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
50268-571-11Modafinil1 in 1 BLISTER PACKTABLET16
50268-571-12Modafinil20 in 1 BOXTABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-571-11EA - Each50268-57126ee742a-6d1c-4d41-9da2-cfb31d66a16312016-09-02
50268-571-12EA - Each50268-571c52ca8ef-21e9-43db-8b08-3b69237f2baa12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-571MODAFINIL TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20220603_4790bbe9-d753-1067-02ee-9536011650d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260218modafinil 100 MG Oral TabletPSN4790bbe9-d753-1067-02ee-9536011650d96
205324modafinil 200 MG Oral TabletPSN4790bbe9-d753-1067-02ee-9536011650d96
260218modafinil 100 MG Oral TabletSCD4790bbe9-d753-1067-02ee-9536011650d96
205324modafinil 200 MG Oral TabletSCD4790bbe9-d753-1067-02ee-9536011650d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-571-11502680571111 in 1 BLISTER PACKHistorical
50268-571-125026805711220 BLISTER PACK in 1 BOX (50268-571-12) / 1 TABLET in 1 BLISTER PACK (50268-571-11) 20 blister pack2016-08-010000-00-00NoNoCurrent