Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
APL HEALTHCARE LIMITED
Aurobindo Pharma Limited
650844777
Aurobindo Pharma Limited
Aurobindo Pharma Limited
650381903
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
65862-602Application Number
ANDA202566Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 11, 2021ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
Modafinil
Product Details
NDC Product Code
65862-601Application Number
ANDA202566Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 11, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT