haracteristics
Color PURPLE (Amethyst) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code NEXIUM40mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-5040-31 30 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
2 NDC:0186-5040-35 30 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
3 NDC:0186-5040-55 90 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
4 NDC:0186-5040-85 1000 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
5 NDC:0186-5040-54 90 CAPSULE, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
6 NDC:0186-5040-82 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 capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5022
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:0186-5022-28 10 CAPSULE, DELAYED RELEASE ( BLISTER PACK) in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021153 07/08/2011
NEXIUM
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5042
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 Characteristics
Color PURPLE (Amethyst) Scor
