Basic Information
ESOMEPRAZOLE MAGNESIUM
50090-3065
Regulatory Information
50090-3065
ANDA203636
C73584
January 7, 2021
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
9
Company Information
830016429
Active Ingredients
SHELLAC
Code: 46N107B71O
Class Code: IACT
ETHYLCELLULOSE, UNSPECIFIED
Code: 7Z8S9VYZ4B
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
GLYCERYL MONOSTEARATE
Code: 230OU9XXE4
Class Code: IACT
GLYCERYL STEARATE SE
Code: FCZ5MH785I
Class Code: IACT
MAGNESIUM OXIDE
Code: 3A3U0GI71G
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
METHACRYLIC ACID
Code: 1CS02G8656
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
POVIDONE K90
Code: RDH86HJV5Z
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
Active Moieties
ESOMEPRAZOLE
Code: N3PA6559FT