Zafirlukast (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zafirlukast tablets 10 mg 60s count container label

10 mg
(click image for full-size original)

zafirlukast tablets 20 mg 60s count container label

20 mg
(click image for full-size original)
ZAFIRLUKAST zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-007
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 MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code V;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-007-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-007-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-007-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-007-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212475 09/10/2020
ZAFIRLUKAST zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-008
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 MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code V;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-008-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:31722-008-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:31722-008-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (31722-008-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212475 09/10/2020
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 ANALYSIS (31722-007), ANALYSIS (31722-008), MANUFACTURE (31722-007), MANUFACTURE (31722-008)

Revised: 09/2020 Camber Pharmaceuticals, Inc.

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