Esomeprazole Magnesium (Page 11 of 11)

Esomeprazole magnesium

Label ImageLabel Image
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5365(NDC:63304-734)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TALC
TRIETHYL CITRATE
POLYSORBATE 80
GELATIN, UNSPECIFIED
SHELLAC
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
STARCH, CORN
SUCROSE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
TITANIUM DIOXIDE
Product Characteristics
Color PINK (pink opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RB;66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5365-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:50090-5365-1 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209735 05/31/2018
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5365), REPACK (50090-5365)

Revised: 03/2021 A-S Medication Solutions

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