Basic Information
Esomeprazole magnesium
50090-5777
Regulatory Information
50090-5777
ANDA210559
C73584
March 23, 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
4
Company Information
830016429
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MEGLUMINE
Code: 6HG8UB2MUY
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
GLYCERYL CAPRYLOCAPRATE
Code: U72Q2I8C85
Class Code: IACT
POLOXAMER 188
Code: LQA7B6G8JG
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
Active Moieties
ESOMEPRAZOLE
Code: N3PA6559FT