Zafirlukast (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 10MG TABLET

label
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 20MG TABLET

20 mg -- label
(click image for full-size original)
ZAFIRLUKAST
zafirlukast tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-549
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZAFIRLUKAST (ZAFIRLUKAST) ZAFIRLUKAST 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
HYPROMELLOSES
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-549-02 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020547 11/19/2010 04/30/2024
ZAFIRLUKAST
zafirlukast tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-554
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
CROSCARMELLOSE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
HYPROMELLOSES
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-554-02 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020547 11/19/2010 09/30/2024
Labeler — Par Pharmaceutical, Inc. (092733690)
Registrant — Par Pharmaceutical Inc. (092733690)

Revised: 11/2018 Par Pharmaceutical, Inc.

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