Basic Information
Esomeprazole magnesium
67877-478
Regulatory Information
67877-478
ANDA208333
C73584
November 27, 2023
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
19
Company Information
141250469
Active Ingredients
POLOXAMER 188
Code: LQA7B6G8JG
Class Code: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Code: NX76LV5T8J
Class Code: IACT
METHYLENE CHLORIDE
Code: 588X2YUY0A
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
GLYCERYL MONOSTEARATE
Code: 230OU9XXE4
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
BEET
Code: N487KM8COK
Class Code: IACT
MEGLUMINE
Code: 6HG8UB2MUY
Class Code: IACT
METHYL ALCOHOL
Code: Y4S76JWI15
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
ESOMEPRAZOLE
Code: N3PA6559FT