Pantoprazole Sodium
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM FOR INJECTION safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM FOR INJECTION. PANTOPRAZOLE SODIUM for injection, for intravenous useInitial U.S. approval: 2000
Approved
Approval ID
b90163d1-3425-42d6-adf3-b9da0e70389a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Methapharm, Inc.
DUNS: 066672887
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 Code67850-150
Application NumberANDA209524
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (3)
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 10 mL
Code: 6871619Q5X
Classification: ACTIM
EDETATE DISODIUMInactive
Quantity: 1 mg in 10 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT