Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
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
71610-685Application Number
ANDA077667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 12, 2023ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8Class: IACT