Prescription Drug Information: Esomeprazole Strontium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24.65 mg brand label
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PRINCIPAL DISPLAY PANEL

49.3 mg brand label
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ESOMEPRAZOLE STRONTIUM esomeprazole strontium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-955
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE STRONTIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
HYPROMELLOSES
METHACRYLIC ACID
POLYSORBATE 80
SUCROSE
TALC
TRIETHYL CITRATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
GLYCERYL MONOSTEARATE
STARCH, CORN
Product Characteristics
Color pink (light pink) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code HMP20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-955-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202342 08/12/2013
ESOMEPRAZOLE STRONTIUM esomeprazole strontium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-957
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE STRONTIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
HYPROMELLOSES
METHACRYLIC ACID
POLYSORBATE 80
SUCROSE
TALC
TRIETHYL CITRATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GLYCERYL MONOSTEARATE
STARCH, CORN
Product Characteristics
Color pink (dark pink) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code HMP40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-957-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202342 08/12/2013
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 829672745 analysis (53746-955), analysis (53746-957), manufacture (53746-955), manufacture (53746-957)
Establishment
Name Address ID/FEI Operations
Hanmi Fine Chemical Co., Ltd 687966986 api manufacture (53746-955), api manufacture (53746-957)

Revised: 11/2022 Amneal Pharmaceuticals of New York LLC

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