NDC 49884-723

Zileuton

Zileuton

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

Product ID49884-723_83a9c9a6-a8a5-4005-b18d-20ab56ef50f3
NDC49884-723
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Multilayer, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA212670
Labeler NamePar Pharmaceutical, 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 Through2021-12-31

Packaging

NDC 49884-723-08

120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (49884-723-08)
Marketing Start Date2020-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-723-08 [49884072308]

Zileuton TABLET, MULTILAYER, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA212670
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-09

Drug Details

Active Ingredients

IngredientStrength
ZILEUTON600 mg/1

Pharmacological Class

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

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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