NDC Code(s) : 61919-789-60, 61919-789-30
Packager : DirectRX

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-789(NDC:67877-478)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MEGLUMINE(UNII: 6HG8UB2MUY)
TALC(UNII: 7SEV7J4R1U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BEET(UNII: N487KM8COK)
POLOXAMER 188(UNII: LQA7B6G8JG)
METHYL ALCOHOL(UNII: Y4S76JWI15)
METHYLENE CHLORIDE(UNII: 588X2YUY0A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SHELLAC(UNII: 46N107B71O)
ALCOHOL(UNII: 3K9958V90M)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color blue (DARK BLUE) Score no score
Shape CAPSULE Size 4 mm
Flavor Imprint Code ESO;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61919-789-6060 in 1 BOTTLE Type 0: Not a Combination Product26/03/2019
2NDC:61919-789-3030 in 1 BOTTLE Type 0: Not a Combination Product26/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208333 03/26/2019

LABELER - DirectRX(079254320)

REGISTRANT - DirectRX(079254320)

Establishment
Name Address ID/FEI Business Operations
DirectRX 079254320 repack(61919-789)

PRINCIPAL DISPLAY PANEL

789-60