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 use Initial U.S. approval: 2000
Approved
Approval ID
52d5bc28-66df-43aa-bb1a-8ac4a2a7f693
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
BE Pharmaceuticals Inc.
DUNS: 081499296
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 Code71839-122
Application NumberANDA216171
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (3)
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 10 mL
Code: 6871619Q5X
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 1 mg in 10 mL
Code: 7FLD91C86K
Classification: IACT