NEXIUM is a registered trademark of the AstraZeneca group of companies.

©2011 AstraZeneca Pharmaceuticals LP. All rights reserved.

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

June 2011

PRINCIPAL DISPLAY PANEL

NEXIUM
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5020
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE)  ESOMEPRAZOLE MAGNESIUM 20mg
 
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
TALC 
TRIETHYL CITRATE 
POLYSORBATE 80 
GELATIN 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
D&C RED NO. 28 
TITANIUM DIOXIDE 
ALCOHOL 
ISOPROPYL ALCOHOL 
BUTYL ALCOHOL 
POLYETHYLENE GLYCOL 
SODIUM HYDROXIDE 
POVIDONE 
D&C YELLOW NO. 10 
 
Product Characteristics
Color PURPLE (Amethyst)  Score no score 
Shape CAPSULE Size 14mm
Flavor  Imprint Code NEXIUM20mg 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-5020-31 30 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
2 NDC:0186-5020-54 90 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
3 NDC:0186-5020-82 1000 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021153 07/08/2011 

NEXIUM
esomeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4010
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE)  ESOMEPRAZOLE MAGNESIUM 10mg
 
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
POTASSIUM SORBATE 
TALC 
TRIETHYL CITRATE 
WATER 
ANHYDROUS DEXTROSE 
POVIDONE 
CITRIC ACID ANHYDROUS 
FERRIC OXIDE YELLOW 
ALCOHOL 
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-4010-01 30 GRANULE, DELAYED RELEASE ( PACKET) in 1 CARTON None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022101 07/08/2011 

NEXIUM
esomeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4020
Ro