PANTOPRAZOLE SODIUM
These highlights do not include all the information needed to use pantoprazole sodium safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets.Pantoprazole Sodium Delayed-Release Tablets, USPInitial U.S. approval: 2000
Approved
Approval ID
18f7b809-b270-4d44-8065-685bac30efc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-124
Application NumberANDA077058
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2010
FDA Product Classification
INGREDIENTS (14)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT