Home NDC 55154-4225 Protonix
Product NDC 55154-4225
11-digit product format 551544225
Labeler code 55154
Product ID 55154-4225_6cf320ab-12a1-4a53-b3ac-2d1a803bdcb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pantoprazole sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Cardinal Health 107, LLC
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020988-001 PROTONIX IV PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020988-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N020988-001 NPP 2027-08-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / IV (INFUSION) AP RLD, RS 2001-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020988-001 PROTONIX IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2001-03-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 81 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020988-001 6780881*PED 2022-05-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020988-001 7351723*PED 2022-05-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020988-001 8754108*PED 2022-05-17 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020988-001 6780881*PED 2022-05-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020988-001 7351723*PED 2022-05-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020988-001 8754108*PED 2022-05-17 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020988-001 6780881*PED 2022-05-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020988-001 7351723*PED 2022-05-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020988-001 8754108*PED 2022-05-17 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020988-001 6780881 2021-11-17 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020988-001 7351723 2021-11-17 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020988-001 8754108 2021-11-17 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020988-001 6780881*PED 2022-05-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020988-001 7351723*PED 2022-05-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020988-001 8754108*PED 2022-05-17 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020988-001 6780881*PED 2022-05-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020988-001 7351723*PED 2022-05-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020988-001 8754108*PED 2022-05-17 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020988-001 6780881 2021-11-17 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020988-001 7351723 2021-11-17 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020988-001 8754108 2021-11-17 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020988-001 6780881*PED 2022-05-17 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020988-001 7351723*PED 2022-05-17 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020988-001 8754108*PED 2022-05-17 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 6780881 2021-11-17 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 7351723 2021-11-17 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 8754108 2021-11-17 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 6780881*PED 2022-05-17 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 7351723*PED 2022-05-17 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020988-001 8754108*PED 2022-05-17 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020988-001 6780881 2021-11-17 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020988-001 7351723 2021-11-17 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020988-001 8754108 2021-11-17 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020988-001 6780881*PED 2022-05-17 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020988-001 7351723*PED 2022-05-17 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020988-001 8754108*PED 2022-05-17 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020988-001 6780881 2021-11-17 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020988-001 7351723 2021-11-17 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020988-001 8754108 2021-11-17 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020988-001 6780881*PED 2022-05-17 Pediatric extension 8869cabd3fbd…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020988-001 NPP 2027-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020988-001 NPP 2027-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020988-001 NPP 2027-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020988-001 NPP 2027-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020988-001 NPP 2027-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020988-001 NPP 2027-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020988-001 NPP 2027-08-12 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020988-001 NPP 2027-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020988-001 NPP 2027-08-12 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020988-001 NPP 2027-08-12 a50c72e98297…
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 Ingredient Strength PANTOPRAZOLE SODIUM 40 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6871619Q5X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283669 Internal RxNorm lookup 885257 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-4225-5 ProtonixI.V. 10 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 10 14 55154-4225-5 ProtonixI.V. 5 in 1 BAG INJECTION, POWDER, FOR SOLUTION 5 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PANTOPRAZOLE SODIUM ACTIVE INGREDIENT 6871619Q5X PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH] 8 PANTOPRAZOLE ACTIVE MOIETY D8TST4O562 PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH] 8 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-4225 PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC] 14 Current NDC, Legacy NDC, 2 package rows 20250427_3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Protonix I.V. PANTOPRAZOLE SODIUM Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 51e4144a-489e-436c-609a-39305f8f56ba 2025-12-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 020988 application number: NDA020988 Protonix I.V. PANTOPRAZOLE SODIUM Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. f39b3e7d-39d2-4c8a-9974-4ab885241880 2025-12-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 020988 application number: NDA020988 Protonix I.V. PANTOPRAZOLE SODIUM Cardinal Health 107, LLC 50802e19-72d3-4130-8d14-eb94361b38e7 2025-08-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 020988 application number: NDA020988 Protonix I.V. PANTOPRAZOLE SODIUM Cardinal Health 107, LLC 3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b 2025-04-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 020988 application number: NDA020988 ndc (product): 55154-4225
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-4225-5 55154422505 5 VIAL in 1 BAG (55154-4225-5) / 10 mL in 1 VIAL 5 vial 2001-05-01 0000-00-00 No No Current