FDA.reportPublic FDA data

ZILEUTON

Product NDC
68180-169
11-digit product format
681800169
Labeler code
68180
Product ID
68180-169_5ccc51b9-399b-4c7e-b2e4-1bde256a0aee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zileuton
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211972
Marketing category
ANDA
Marketing start
2020-08-10
Marketing end
0000-00-00
Substance
ZILEUTON
Active strength
600 1/1
Pharmacologic classes
5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ab1cd6a-2e03-4fd2-842b-497a1f1ff461Product name420231219
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4fad46b7-5f43-5163-8976-8a0f23153295Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68180-169-072023-01-30C16284748780-1f386c649-db05-0266-e053-dadaa90a7c1aThese 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
68180-169-162023-01-30C16284748780-1f386c649-db05-0266-e053-dadaa90a7c1aThese 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
68180-169-262023-01-30C16284748780-1f386c649-db05-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-169-07ZILEUTON60 in 1 BOTTLETABLET, EXTENDED RELEASE605
68180-169-16ZILEUTON120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
68180-169-26ZILEUTON180 in 1 BOTTLETABLET, EXTENDED RELEASE1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-169-16EA - Each68180-16985afb264-a543-47a3-997e-21cdc38f876212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-169ZILEUTON TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20200814_cf392f79-2276-4fe1-8fa8-74afd5150f73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730834zileuton 600 MG 12HR Extended Release Oral TabletPSNcf392f79-2276-4fe1-8fa8-74afd5150f735
73083412 HR zileuton 600 MG Extended Release Oral TabletSCDcf392f79-2276-4fe1-8fa8-74afd5150f735
730834zileuton 600 MG 12 HR Extended Release Oral TabletSYcf392f79-2276-4fe1-8fa8-74afd5150f735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-169-076818001690760 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-07) 2020-08-100000-00-00NoNoCurrent
68180-169-1668180016916120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-16) 2020-08-100000-00-00NoNoCurrent
68180-169-2668180016926180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-26) 2020-08-100000-00-00NoNoCurrent