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
f9be6294-9a16-4de1-b346-af0d09a97482
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-6038
Application NumberANDA077056
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2012
FDA Product Classification
INGREDIENTS (21)
PANTOPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Pantoprazole Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5846
Application NumberANDA077056
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2012
FDA Product Classification
INGREDIENTS (21)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT