FDA.reportPublic FDA data

Protonix

Product NDC
0008-0843
11-digit product format
000080843
Labeler code
0008
Product ID
0008-0843_b1adaee5-9353-48ce-bde4-f169a3787e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA020987
Marketing category
NDA
Marketing start
2000-05-01
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Protonix
Brand name suffix
Delayed-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872, 284400, 314200, 352125, 763306, 763308

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0008-0843-812024-01-30C16284748780-11030e364-f951-111a-e063-dadaa90a10e2These 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 use PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-0843-81ProtonixDelayed-Release90 in 1 BOTTLETABLET, DELAYED RELEASE9048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-0843-81EA - Each0008-08432881cb02-d98a-4779-baa2-368d6867820312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
MANNITOLINACTIVE INGREDIENT3OWL53L36APROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TALCINACTIVE INGREDIENT7SEV7J4R1UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-0843PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]47Current NDC, Legacy NDC, 1 package rows20240719_08098cb2-c048-4640-f387-6beec4a38936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN08098cb2-c048-4640-f387-6beec4a3893648
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN08098cb2-c048-4640-f387-6beec4a3893648
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN08098cb2-c048-4640-f387-6beec4a3893648
352125Protonix 20 MG Delayed Release Oral TabletPSN08098cb2-c048-4640-f387-6beec4a3893648
763308Protonix 40 MG Delayed Release Oral GranulesPSN08098cb2-c048-4640-f387-6beec4a3893648
284400Protonix 40 MG Delayed Release Oral TabletPSN08098cb2-c048-4640-f387-6beec4a3893648
352125pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]SBD08098cb2-c048-4640-f387-6beec4a3893648
284400pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]SBD08098cb2-c048-4640-f387-6beec4a3893648
763308pantoprazole 40 MG Oral Granules [Protonix]SBD08098cb2-c048-4640-f387-6beec4a3893648
251872pantoprazole 20 MG Delayed Release Oral TabletSCD08098cb2-c048-4640-f387-6beec4a3893648
314200pantoprazole 40 MG Delayed Release Oral TabletSCD08098cb2-c048-4640-f387-6beec4a3893648
763306pantoprazole 40 MG Oral GranulesSCD08098cb2-c048-4640-f387-6beec4a3893648
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY08098cb2-c048-4640-f387-6beec4a3893648
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY08098cb2-c048-4640-f387-6beec4a3893648
352125Protonix 20 MG Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
284400Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
763308Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY08098cb2-c048-4640-f387-6beec4a3893648
284400Protonix 40 MG Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
763308Protonix 40 MG Enteric Coated Oral Granules for Oral SuspensionSY08098cb2-c048-4640-f387-6beec4a3893648
763308Protonix 40 MG Oral GranulesSY08098cb2-c048-4640-f387-6beec4a3893648
352125Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY08098cb2-c048-4640-f387-6beec4a3893648
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN72f82e7c-fdfb-4d54-8161-944ba00b700e3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN72f82e7c-fdfb-4d54-8161-944ba00b700e3
352125Protonix 20 MG Delayed Release Oral TabletPSN72f82e7c-fdfb-4d54-8161-944ba00b700e3
284400Protonix 40 MG Delayed Release Oral TabletPSN72f82e7c-fdfb-4d54-8161-944ba00b700e3
352125pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]SBD72f82e7c-fdfb-4d54-8161-944ba00b700e3
284400pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]SBD72f82e7c-fdfb-4d54-8161-944ba00b700e3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD72f82e7c-fdfb-4d54-8161-944ba00b700e3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD72f82e7c-fdfb-4d54-8161-944ba00b700e3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
352125Protonix 20 MG Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
284400Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
284400Protonix 40 MG Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
352125Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY72f82e7c-fdfb-4d54-8161-944ba00b700e3
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe6238767-90da-4176-8ac6-d71c2025dcb51
352125Protonix 20 MG Delayed Release Oral TabletPSNe6238767-90da-4176-8ac6-d71c2025dcb51
352125pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]SBDe6238767-90da-4176-8ac6-d71c2025dcb51
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe6238767-90da-4176-8ac6-d71c2025dcb51
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe6238767-90da-4176-8ac6-d71c2025dcb51
352125Protonix 20 MG Delayed Release Oral TabletSYe6238767-90da-4176-8ac6-d71c2025dcb51
352125Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe6238767-90da-4176-8ac6-d71c2025dcb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0008-0843-810000808438190 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0843-81) 2000-05-010000-00-00NoNoCurrent