Pantoprazole Sodium
REPACKAGED PANTOPRAZOLE SODIUM DELAYED-RELEASE (DR) TABLETS These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS Initial U.S. Approval: 2000
Approved
Approval ID
61cf498c-d6b8-5e26-e053-2991aa0a59c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2018
Manufacturers
FDA
California Pharmaceutical, LLC
DUNS: 021420944
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 Code70332-301
Application NumberANDA078281
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pantoprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2018
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT