Pantoprazole sodium
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL SUSPENSION. PANTOPRAZOLE SODIUM for delayed-release oral suspension Initial U.S. approval: 2000
Approved
Approval ID
90963a38-f629-45a4-bddd-9e13a55fe0f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-256
Application NumberANDA217416
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT