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 Initial U.S. approval: 2000
Approved
Approval ID
ee114ab9-db51-4a71-90b9-cd9865e4fced
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2011
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
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 Code55648-433
Application NumberANDA091231
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2010
FDA Product Classification
INGREDIENTS (22)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 6871619Q5X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PANTOPRAZOLE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-434
Application NumberANDA091231
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2010
FDA Product Classification
INGREDIENTS (21)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIB
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT