Zileuton (Page 5 of 5)

Zileuton Extended-Release Tablets
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ZILEUTON
zileuton tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-485
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZILEUTON (ZILEUTON) ZILEUTON 600 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE RED
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
Product Characteristics
Color white (WHITE (one red layer between two white layers)) Score no score
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code CT2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-485-32 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022052 03/29/2017
Labeler — Prasco, LLC (065969375)
Registrant — Chiesi USA, Inc. (088084228)

Revised: 03/2019 Prasco, LLC

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