NDC 64980-206

Zileuton

Zileuton

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

Product ID64980-206_8dce022f-3b33-4a0a-85e5-c2bc460e2f7a
NDC64980-206
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-21
Marketing CategoryANDA / ANDA
Application NumberANDA204929
Labeler NameRising Pharmaceuticals, Inc.
Substance NameZILEUTON
Active Ingredient Strength600 mg/1
Pharm Classes5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64980-206-12

120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)
Marketing Start Date2017-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-206-12 [64980020612]

Zileuton TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-21

Drug Details

Active Ingredients

IngredientStrength
ZILEUTON600 mg/1

OpenFDA Data

SPL SET ID:fd382540-b390-4e86-a94a-988ea89c93a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 730834
  • Pharmacological Class

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

    Medicade Reported Pricing

    64980020612 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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