Modafinil

Product NDC
42291-600
11-digit product format
422910600
Labeler code
42291
Product ID
42291-600_ba4d863d-be3a-8cf5-e053-2995a90a69fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076715
Marketing category
ANDA
Marketing start
2013-04-03
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-600-01EA - Each42291-60045169d60-3ebd-4a15-ac6f-70e60849bf4212014-05-02
42291-600-30EA - Each42291-600212717e6-587c-4902-ad23-508f9b4d7adc12014-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-600-304229106003030 TABLET in 1 BOTTLE (42291-600-30) 30 tablet2013-04-030000-00-00NoNoCurrent