NDC 68180-169

ZILEUTON

Zileuton

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

Product ID68180-169_5ccc51b9-399b-4c7e-b2e4-1bde256a0aee
NDC68180-169
Product TypeHuman Prescription Drug
Proprietary NameZILEUTON
Generic NameZileuton
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA211972
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameZILEUTON
Active Ingredient Strength600 1/1
Pharm Classes5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68180-169-07

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-07)
Marketing Start Date2020-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-169-16 [68180016916]

ZILEUTON TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

NDC 68180-169-07 [68180016907]

ZILEUTON TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

NDC 68180-169-26 [68180016926]

ZILEUTON TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
ZILEUTON600 1/1

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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