Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Orchid Pharma Ltd.
650133507
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Orchid Healthcare (A Division of Orchid Pharma Ltd)
OrchidPharma Inc
Orchid Pharma Ltd.
650288850
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Modafinil
Product Details
NDC Product Code
42043-160Application Number
ANDA078963Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 13, 2022CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
Modafinil
Product Details
NDC Product Code
42043-161Application Number
ANDA078963Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 13, 2022ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT