FDA.reportPublic FDA data

12 HR zileuton 600 MG Extended Release Oral Tablet

RxCUI
730834
RxNorm name
12 HR zileuton 600 MG Extended Release Oral Tablet
Display name
12 HR zileuton 600 MG Extended Release Oral Tablet
Full name
12 HR zileuton 600 MG Extended Release Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZileutonZILEUTONRising Pharma Holdings, Inc.fd382540-b390-4e86-a94a-988ea89c93a82024-05-15Warnings, Adverse reactionsExact identifier
rxcui: 730834
ZileutonZILEUTONNorthStar RxLLCbc29c998-1324-46aa-8386-e5b2fc9e0b162024-05-02Warnings, Adverse reactionsExact identifier
rxcui: 730834
ZileutonZILEUTONGolden State Medical Supply, Inc.f7573809-7741-04c9-e053-6294a90ab1932023-03-20Warnings, Adverse reactionsExact identifier
rxcui: 730834
ZileutonZILEUTONCamber Pharmaceuticals, Inc.94313e24-9534-4b6c-b374-c436c49163032022-10-14Warnings, Adverse reactionsExact identifier
rxcui: 730834
ZileutonZILEUTONStrides Pharma Science Limiteda826d16f-df07-447b-b050-b9a02ea1f89e2022-07-29Warnings, Adverse reactionsExact identifier
rxcui: 730834

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fd382540-b390-4e86-a94a-988ea89c93a8zileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]37These 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: 199620240515
cf392f79-2276-4fe1-8fa8-74afd5150f73zileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]35These 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: 199620200813
94313e24-9534-4b6c-b374-c436c4916303zileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]32These 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: 199620221014
a826d16f-df07-447b-b050-b9a02ea1f89ezileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]32These 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: 199620220729
bc29c998-1324-46aa-8386-e5b2fc9e0b16zileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]31These 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: 199620240502
f7573809-7741-04c9-e053-6294a90ab193zileuton 600 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR zileuton 600 MG Extended Release Oral Tablet [SCD] · zileuton 600 MG 12 HR Extended Release Oral Tablet [SY]31ZILEUTON EXTENDED-RELEASE TABLETS. 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: 199620230320