Modafinil

Product NDC
42043-160
11-digit product format
420430160
Labeler code
42043
Product ID
42043-160_dc738068-3e56-47c5-afd8-7d471303c041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA078963
Marketing category
ANDA
Marketing start
2013-08-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42043-160-01EA - Each42043-1607bb97d9a-9b81-40f4-98df-927be68ccbaa12013-09-04
42043-160-03EA - Each42043-1607be295cc-f2b3-44e7-a256-a98ea294db0e12013-09-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42043-160-01420430160011 BOTTLE, PLASTIC in 1 CARTON (42043-160-01) > 100 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent
42043-160-03420430160031 BOTTLE, PLASTIC in 1 CARTON (42043-160-03) > 30 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent
42043-160-90420430160901 BOTTLE, PLASTIC in 1 CARTON (42043-160-90) > 90 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent