Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021957 07/08/2011 

NEXIUM
esomeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4040
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE)  ESOMEPRAZOLE MAGNESIUM 40mg
 
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:0186-4040-01 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 NDA021957 07/08/2011 

NEXIUM
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5040
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE)  ESOMEPRAZOLE MAGNESIUM 40mg
 
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 C