NDC 31722-044

Zileuton

Zileuton

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

Product ID31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079
NDC31722-044
Product TypeHuman Prescription Drug
Proprietary NameZileuton
Generic NameZileuton
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-10-11
Marketing CategoryANDA /
Application NumberANDA215742
Labeler NameCamber Pharmaceuticals, Inc.
Substance NameZILEUTON
Active Ingredient Strength600 mg/1
Pharm Classes5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 31722-044-12

120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12)
Marketing Start Date2022-10-11
NDC Exclude FlagN
Sample Package?N

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.