Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
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
55700-695Application Number
ANDA077667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 20, 2018MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1