NDC 0008-4001-01 - Protonix I.V.
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0008-4001
- Requested NDC
- 0008-4001-01
- Package NDCs from labels
- 0008-4001-01, 0008-4001-10, 0008-4001-25
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Takeda GmbH | Pharmacia & Upjohn Company LLC
- Effective date
- 2025-12-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Takeda GmbH | Pharmacia & Upjohn Company LLC | 2025-12-22 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0008-4001-01 | ProtonixI.V. | 10 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 10 | 24 | |
| 0008-4001-01 | ProtonixI.V. | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | 24 | |
| 0008-4001-10 | ProtonixI.V. | 10 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 10 | 24 | |
| 0008-4001-25 | ProtonixI.V. | 25 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 25 | 24 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0008-4001 | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 23 | Current NDC, Legacy NDC, 4 package rows | 20250228_f39b3e7d-39d2-4c8a-9974-4ab885241880.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0008-4001-01 | EA - Each | 0008-4001 | 8cb12a14-455e-408d-a42d-5d97a6b57293 | 1 | 2013-08-02 |
| 0008-4001-10 | EA - Each | 0008-4001 | da10639e-5edd-4b53-8b2a-8d285f876131 | 1 | 2013-07-02 |
| 0008-4001-25 | EA - Each | 0008-4001 | e2b2e4d7-a155-42d6-ac89-28220d0e474c | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pantoprazole | PANTOPRAZOLE | St. Mary's Medical Park Pharmacy | ed264262-21bb-1bae-e053-2995a90a8a5e | 2026-06-17 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Bryant Ranch Prepack | 03dea010-4bae-43ab-893e-9bbddb58062d | 2026-06-05 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Coupler LLC | 5331f534-4724-52e8-e063-6394a90aa548 | 2026-06-01 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Coupler LLC | 52bbab54-9f11-77bc-e063-6394a90ab449 | 2026-05-26 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole sodium | PANTOPRAZOLE SODIUM | Gland Pharma Limited | c1ad8f91-3783-4139-8154-e461a53809c1 | 2026-05-19 | Warnings, Adverse reactions | 283669 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Bryant Ranch Prepack | 9a1159d3-b9fa-4026-962c-d3001002e610 | 2026-05-19 | Warnings, Adverse reactions | 6871619Q5X |
| Protonix Delayed-Release | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 08098cb2-c048-4640-f387-6beec4a38936 | 2026-05-18 | Warnings, Adverse reactions | 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Bryant Ranch Prepack | fa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a | 2026-05-13 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | QPharma Inc | 0e200326-8885-18d0-e063-6294a90aad2f | 2026-05-11 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole | PANTOPRAZOLE | NuCare Pharmaceuticals,Inc. | 51033ddc-a11a-80fa-e063-6394a90ac54c | 2026-05-04 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Northstar Rx LLC | 7e0c5dac-6832-4692-b012-ca59d5e88987 | 2026-04-08 | Warnings, Adverse reactions | 283669 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Safecor Health LLC | 5e1cbf26-d379-4315-8732-3939968f32c0 | 2026-04-07 | Warnings, Adverse reactions | 6871619Q5X |
| pantoprazole sodium | PANTOPRAZOLE SODIUM | Granules Pharmaceuticals Inc. | 8f2fb647-15bc-41cb-84a4-02e956e614fc | 2026-04-06 | Warnings, Adverse reactions | 6871619Q5X |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 50802e19-72d3-4130-8d14-eb94361b38e7 | 2026-04-06 | Warnings, Adverse reactions | NDA020988 283669 885257 6871619Q5X |
| Pantoprazole Sodium DR | PANTOPRAZOLE SODIUM DR | Direct_Rx | 0515ceaa-7d17-c92f-e063-6294a90a044e | 2026-03-05 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE | Amneal Pharmaceuticals LLC | f3ded82a-cf0d-4844-944a-75f9f9215ff0 | 2026-03-03 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 6b5ed424-2203-482f-bb85-2c97d9c356f2 | 2026-02-27 | Warnings, Adverse reactions | 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | PD-Rx Pharmaceuticals, Inc. | c1f37929-a981-4ace-95e6-ae6795a797b3 | 2026-02-25 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Major Pharmaceuticals | 9c286e5c-2b36-422b-9f74-e8c0abb3f747 | 2026-02-12 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Aurobindo Pharma Limited | 7418f358-f536-4de6-adf0-562b4373f2e3 | 2026-02-06 | Warnings, Adverse reactions | 6871619Q5X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.