Protonix

Product NDC
0008-0923
11-digit product format
000080923
Labeler code
0008
Product ID
0008-0923_a7e7d657-a748-4234-8dd6-c0e4d0f81a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA020988
Marketing category
NDA
Marketing start
2001-05-01
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/10mL
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Protonix
Brand name suffix
I.V.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui283669, 885257

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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-0923-51ProtonixI.V.10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1060
0008-0923-51ProtonixI.V.1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION160
0008-0923-55ProtonixI.V.10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION1060
0008-0923-55ProtonixI.V.1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION160
0008-0923-60ProtonixI.V.1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION160
0008-0923-60ProtonixI.V.25 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION2560

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-0923-51EA - Each0008-0923381ac81f-a008-4862-95a4-910aecb09b7312012-07-24
0008-0923-55EA - Each0008-09237d632202-b348-4284-b406-b9d69233ea2012012-07-24
0008-0923-60EA - Each0008-09234d54a896-d620-4e4d-b09b-f4bcb5eb786112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]34
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]34
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]34
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]34
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]8
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]8
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-0923PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]59Current NDC, Legacy NDC, 6 package rows20250228_51e4144a-489e-436c-609a-39305f8f56ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN51e4144a-489e-436c-609a-39305f8f56ba60
885257PROTONIX 40 MG InjectionPSN51e4144a-489e-436c-609a-39305f8f56ba60
885257pantoprazole 40 MG Injection [Protonix]SBD51e4144a-489e-436c-609a-39305f8f56ba60
283669pantoprazole 40 MG InjectionSCD51e4144a-489e-436c-609a-39305f8f56ba60
283669pantoprazole (as sodium) 40 MG InjectionSY51e4144a-489e-436c-609a-39305f8f56ba60
885257Protonix 40 MG InjectionSY51e4144a-489e-436c-609a-39305f8f56ba60
283669pantoprazole 40 MG InjectionPSN3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
885257PROTONIX 40 MG InjectionPSN3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
885257pantoprazole 40 MG Injection [Protonix]SBD3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
283669pantoprazole 40 MG InjectionSCD3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
283669pantoprazole (as sodium) 40 MG InjectionSY3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
885257Protonix 40 MG InjectionSY3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b14
283669pantoprazole 40 MG InjectionPSN50802e19-72d3-4130-8d14-eb94361b38e710
885257PROTONIX 40 MG InjectionPSN50802e19-72d3-4130-8d14-eb94361b38e710
885257pantoprazole 40 MG Injection [Protonix]SBD50802e19-72d3-4130-8d14-eb94361b38e710
283669pantoprazole 40 MG InjectionSCD50802e19-72d3-4130-8d14-eb94361b38e710
283669pantoprazole (as sodium) 40 MG InjectionSY50802e19-72d3-4130-8d14-eb94361b38e710
885257Protonix 40 MG InjectionSY50802e19-72d3-4130-8d14-eb94361b38e710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0008-0923-51000080923511 VIAL in 1 CARTON (0008-0923-51) / 10 mL in 1 VIAL1 vial2001-05-010000-00-00NoNoCurrent
0008-0923-550000809235510 CARTON in 1 PACKAGE (0008-0923-55) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL10 carton2001-05-010000-00-00NoNoCurrent
0008-0923-600000809236025 CARTON in 1 PACKAGE (0008-0923-60) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL25 carton2001-05-010000-00-00NoNoCurrent