Zafirlukast (Page 6 of 6)

Carton Label

carton20mg
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Zafirlukast 20 mg tabs

Label ImageLabel Image
ZAFIRLUKAST
zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-1977(NDC:55111-626)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZAFIRLUKAST (ZAFIRLUKAST) ZAFIRLUKAST 20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
lactose monohydrate
magnesium stearate
MICROCRYSTALLINE CELLULOSE
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code R;626
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-1977-6 1 TABLET, FILM COATED in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090372 11/18/2010
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-1977)

Revised: 01/2019 Carilion Materials Management

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