Basic Information
Esomeprazole Magnesium
0904-6581
Regulatory Information
0904-6581
ANDA078279
C73584
December 13, 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
191427277
Active Ingredients
Propylene Glycol
Code: 6DC9Q167V3
Class Code: IACT
Potassium Hydroxide
Code: WZH3C48M4T
Class Code: IACT
Shellac
Code: 46N107B71O
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
Magnesium Stearate
Code: 70097M6I30
Class Code: IACT
Methacrylic Acid
Code: 1CS02G8656
Class Code: IACT
Polysorbate 80
Code: 6OZP39ZG8H
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
Ammonia
Code: 5138Q19F1X
Class Code: IACT
Ferrosoferric Oxide
Code: XM0M87F357
Class Code: IACT
Butyl Alcohol
Code: 8PJ61P6TS3
Class Code: IACT
Alcohol
Code: 3K9958V90M
Class Code: IACT
Isopropyl Alcohol
Code: ND2M416302
Class Code: IACT
Glyceryl Monostearate
Code: 230OU9XXE4
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
Talc
Code: 7SEV7J4R1U
Class Code: IACT
Active Moieties
Esomeprazole
Code: N3PA6559FT