NDC Code(s) : 55700-428-30
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-428(NDC:13668-155)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE40 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
GELATIN(UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID(UNII: 1CS02G8656)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POVIDONE(UNII: FZ989GH94E)
POVIDONE K90(UNII: RDH86HJV5Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code 40;1155
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-428-3030 in 1 BOTTLE Type 0: Not a Combination Product19/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203636 10/19/2015

LABELER - Lake Erie Medical DBA Quality Care Products LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel(55700-428)

PRINCIPAL DISPLAY PANEL

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