Modafinil

Product NDC
68788-8079
11-digit product format
687888079
Labeler code
68788
Product ID
68788-8079_c5a78d1e-9c49-469e-9e4e-448868f51749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078963
Marketing category
ANDA
Marketing start
2021-09-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8079-3EA - Each68788-8079b09b7e57-eeb8-4f08-bd7b-90e51945cf9b12021-10-08
68788-8079-6EA - Each68788-8079f774aa4d-6636-4eaf-91bb-f2400a45394912021-10-08
68788-8079-9EA - Each68788-8079e2df0368-5c10-42ca-a664-c735cfec3f4612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8079MODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240720_6b17c2da-7538-4e8b-89c3-a1f9ec532ac0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8079-3687888079031 BOTTLE, PLASTIC in 1 CARTON (68788-8079-3) > 30 TABLET in 1 BOTTLE, PLASTIC2021-09-030000-00-00NoNoCurrent
68788-8079-66878880790660 TABLET in 1 BOTTLE, PLASTIC (68788-8079-6) 60 tablet2021-09-030000-00-00NoNoCurrent
68788-8079-96878880790990 TABLET in 1 BOTTLE, PLASTIC (68788-8079-9) 90 tablet2021-09-030000-00-00NoNoCurrent