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
cf392f79-2276-4fe1-8fa8-74afd5150f73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 13, 2020
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-169
Application NumberANDA211972
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zileuton
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2020
FDA Product Classification
INGREDIENTS (11)
ZILEUTONActive
Quantity: 600 1 in 1 1
Code: V1L22WVE2S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT