ZYFLO (Page 4 of 4)

Zyflo Bottle
(click image for full-size original)
ZYFLO
zileuton tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-901
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor Imprint Code CT1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10122-901-12 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020471 12/06/1996
Labeler — Chiesi USA, Inc. (088084228)
Registrant — Chiesi USA, Inc. (088084228)

Revised: 01/2022 Chiesi USA, Inc.

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