Protonix
These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets, for oral usePROTONIX (pantoprazole sodium) for delayed-release oral suspensionInitial U.S. approval: 2000
Approved
Approval ID
08098cb2-c048-4640-f387-6beec4a38936
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2023
Manufacturers
FDA
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
DUNS: 113008515
Products 3
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 Code0008-0844
Application NumberNDA022020
Product Classification
M
Marketing Category
C73594
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (15)
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
PANTOPRAZOLE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-0841
Application NumberNDA020987
Product Classification
M
Marketing Category
C73594
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (15)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
PANTOPRAZOLE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-0843
Application NumberNDA020987
Product Classification
M
Marketing Category
C73594
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (15)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT