Basic Information
Esomeprazole Magnesium
68071-2649
Regulatory Information
68071-2649
ANDA211977
C73584
March 1, 2022
USA
These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE magnesium delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
010632300
Active Ingredients
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
HYDROXYPROPYL CELLULOSE
Code: RFW2ET671P
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
GLYCERYL MONOSTEARATE
Code: 230OU9XXE4
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
SHELLAC
Code: MB5IUD6JUA
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
DIMETHICONE
Code: 92RU3N3Y1O
Class Code: IACT
Active Moieties
ESOMEPRAZOLE
Code: N3PA6559FT