NDC Code(s) : 0310-0401-60, 0310-0402-60
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACCOLATEZafirlukast TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZAFIRLUKAST(UNII: XZ629S5L50)
(ZAFIRLUKAST - UNII:XZ629S5L50) 		ZAFIRLUKAST10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONES(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 6 mm
Flavor Imprint Code ACCOLATE10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-0401-6060 in 1 BOTTLE Type 0: Not a Combination Product01/10/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020547 10/01/1996 04/28/2017
ACCOLATEZafirlukast TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-0402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZAFIRLUKAST(UNII: XZ629S5L50)
(ZAFIRLUKAST - UNII:XZ629S5L50) 		ZAFIRLUKAST20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONES(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code ACCOLATE20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-0402-6060 in 1 BOTTLE Type 0: Not a Combination Product01/10/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020547 10/01/1996 09/29/2017

PRINCIPAL DISPLAY PANEL

NDC 0310-0401-60

60 tablets

ACCOLATE®

ZAFIRLUKAST

10 mg tablets

Rx only

DISPENSE IN THE ORIGINAL

AIRTIGHT CONTAINER.

Mfd. for: AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

By: IPR Pharmaceuticals, Inc.

Canóvanas, PR 00729

Product of UK

AstraZeneca

ACCOLATE 10 mg tablets Bottle Label 60 tablets

PRINCIPAL DISPLAY PANEL

NDC 0310-0402-60

60 tablets

ACCOLATE®

ZAFIRLUKAST

20 mg tablets

Rx only

DISPENSE IN THE ORIGINAL

AIRTIGHT CONTAINER.

Mfd. for: AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

By: IPR Pharmaceuticals, Inc.

Canóvanas, PR 00729

Product of UK

AstraZeneca

ACCOLATE 20 mg tablets Bottle Label 60 tablets