NDC 66993-485

Zileuton

Zileuton

Zileuton is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Prasco, Llc. The primary component is Zileuton.

Product ID66993-485_2e8fb82e-859f-4ca1-807b-80b052888ab1
NDC66993-485
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-29
Marketing CategoryNDA AUTHORIZED / NDA AUTHORIZED GENERIC
Application NumberNDA022052
Labeler NamePrasco, LLC
Substance NameZILEUTON
Active Ingredient Strength600 mg/1
Pharm Classes5-Lipoxygenase
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66993-485-32

120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-485-32)
Marketing Start Date2017-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66993-485-32 [66993048532]

Zileuton TABLET, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-29

Drug Details

Active Ingredients

IngredientStrength
ZILEUTON600 mg/1

OpenFDA Data

SPL SET ID:eac21801-4b9b-41bc-a37d-e30d43639d5e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 730834
  • UPC Code
  • 0366993485324
  • Pharmacological Class

    • 5-Lipoxygenase Inhibitors [MoA]
    • Decreased Leukotriene Production [PE]
    • 5-Lipoxygenase Inhibitor [EPC]

    Medicade Reported Pricing

    66993048532 ZILEUTON ER 600 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Zileuton" or generic name "Zileuton"

    NDCBrand NameGeneric Name
    31722-044ZileutonZileuton
    49884-723Zileutonzileuton
    64380-189Zileutonzileuton
    64980-206ZileutonZileuton
    66993-485ZileutonZileuton
    68180-169ZILEUTONZileuton
    69339-130Zileutonzileuton
    10122-901ZYFLOzileuton
    10122-902ZYFLO CRzileuton

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