Zileuton
These highlights do not include all the information needed to use ZILEUTON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZILEUTON EXTENDED-RELEASE TABLETS. ZILEUTON extended-release tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
fd382540-b390-4e86-a94a-988ea89c93a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zileuton
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-206
Application NumberANDA204929
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zileuton
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (15)
ZileutonActive
Quantity: 600 mg in 1 1
Code: V1L22WVE2S
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2208 (200000 MPA.S)Inactive
Code: LJY3MA129D
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT