Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited
650574671
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
46708-385Application Number
ANDA202700Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 3, 2022LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Modafinil
Product Details
NDC Product Code
46708-386Application Number
ANDA202700Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 3, 2022ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT