Pantoprazole Sodium
These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets USP. PANTOPRAZOLE sodium delayed-release tablets USP for oral useInitial U.S. Approval: 2000
Approved
Approval ID
a81dc60e-af42-4d5a-ba21-865fec74ce05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pantoprazole Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-771
Application NumberANDA077056
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (22)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT