NDC Code(s) : 68071-2970-9
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Esomeprazole MagnesiumEsomeprazole Magnesium CAPSULE, COATED PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2970(NDC:67877-572)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
POLOXAMER 188(UNII: LQA7B6G8JG)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code ESOM;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-2970-990 in 1 BOTTLE Type 0: Not a Combination Product04/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210559 02/27/2021

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-2970)

PRINCIPAL DISPLAY PANEL

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