Modafinil

Product NDC
63629-4998
11-digit product format
636294998
Labeler code
63629
Product ID
63629-4998_299a585f-fed1-49f2-8750-657b1c5e0c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202566
Marketing category
ANDA
Marketing start
2012-09-27
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4998-16362949980130 TABLET in 1 BOTTLE (63629-4998-1) 30 tablet2013-04-240000-00-00NoNoCurrent
63629-4998-26362949980260 TABLET in 1 BOTTLE (63629-4998-2) 60 tablet2013-06-270000-00-00NoNoCurrent
63629-4998-36362949980328 TABLET in 1 BOTTLE (63629-4998-3) 28 tablet2022-02-080000-00-00NoNoCurrent
63629-4998-46362949980418 TABLET in 1 BOTTLE (63629-4998-4) 18 tablet2022-02-080000-00-00NoNoCurrent