Basic Information
PANTOPRAZOLE SODIUM
53002-2419
Regulatory Information
53002-2419
ANDA202882
C73584
July 21, 2022
USA
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
147096275
Active Ingredients
Inactive Ingredients
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
CALCIUM STEARATE
Code: 776XM7047L
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
Code: 74G4R6TH13
Class Code: IACT
SODIUM CARBONATE
Code: 45P3261C7T
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
CARNAUBA WAX
Code: R12CBM0EIZ
Class Code: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Code: 9XZ8H6N6OH
Class Code: IACT
Active Moieties
PANTOPRAZOLE
Code: D8TST4O562