Modafinil

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

A-S Medication Solutions

DUNS Number

830016429

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

50090-3865

Application Number

ANDA076715

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 31, 2016

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT