Esomeprazole Magnesium (Page 12 of 12)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — (30 Capsules Bottle)

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ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-892(NDC:65862-783)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM CARBONATE
MAGNESIUM OXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
GLYCERYL COCOATE
POLYSORBATE 80
DEXTROSE
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
GELATIN
SODIUM LAURYL SULFATE
SHELLAC
FERRIC OXIDE YELLOW
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code I81
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-892-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:45865-892-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205606 04/21/2016
Labeler — medsourcer pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-892)

Revised: 12/2018 medsourcer pharmaceuticals

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