NDC 80425-0133-01 - Pantoprazole Sodium DR
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
- 80425-0133
- Requested NDC
- 80425-0133-01
- Package NDCs from labels
- 80425-0133-3, 80425-0133-2, 80425-0133-1, 80425-0133-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Pantoprazole Sodium DR - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0133-1 | Pantoprazole SodiumDR | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 9 | |
| 80425-0133-2 | Pantoprazole SodiumDR | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 9 | |
| 80425-0133-3 | Pantoprazole SodiumDR | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0133 | PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250101_bd4759ac-46b5-6903-e053-2a95a90a6319.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0133-1 | EA - Each | 80425-0133 | 0f55e92b-0d43-402f-8fda-9d2c62a28aac | 1 | 2023-04-07 |
| 80425-0133-2 | EA - Each | 80425-0133 | a0ce25ef-3ad1-4dde-931a-0ef255b0b95e | 1 | 2023-04-07 |
| 80425-0133-3 | EA - Each | 80425-0133 | 13c7d2f8-3fce-4fb9-89a4-42818217f346 | 1 | 2023-04-07 |
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 Sodium | PANTOPRAZOLE SODIUM | NorthStar Rx LLC | 6637d90b-b268-4a5f-ab5b-885f2d5f0d4b | 2026-02-06 | Warnings, Adverse reactions | 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Burel Pharmaceuticals, LLC | 3cc5197e-6b39-4415-b963-d4bbeecd7953 | 2026-02-06 | Warnings, Adverse reactions | 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Torrent Pharmaceuticals Limited | 9c983da1-a8e0-479e-8816-5d5668ea242e | 2026-02-05 | Warnings, Adverse reactions | 251872 314200 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Camber Pharmaceuticals, Inc. | 9daa1483-5a36-44db-9e0d-904d100da262 | 2026-01-22 | Warnings, Adverse reactions | ANDA202882 31722-713 251872 314200 48f42a12-2eac-e5dd-e063-6294a90aa92d 9daa1483-5a36-44db-9e0d-904d100da262 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 6229247e-ee15-466e-a8ac-adcd646b738d | 2026-01-22 | Warnings, Adverse reactions | 251872 314200 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Quallent Pharmaceuticals Health LLC | 643eb498-d916-4fb7-9281-32895575ab36 | 2026-01-13 | Warnings, Adverse reactions | ANDA202882 251872 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | AvPAK | dcac4022-fea1-67c5-3331-fefcc3c440d8 | 2026-01-09 | Warnings, Adverse reactions | 251872 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Major Pharmaceuticals | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 2026-01-08 | Warnings, Adverse reactions | 251872 314200 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Northwind Health Company, LLC | da67e1c0-9947-957d-e053-2a95a90ad96d | 2026-01-01 | Warnings, Adverse reactions | ANDA202882 251872 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Northwind Health Company, LLC | f2a1af50-a051-3e55-e053-2a95a90a9184 | 2026-01-01 | Warnings, Adverse reactions | 251872 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Northwind Health Company, LLC | d9deb251-96d3-5f96-e053-2a95a90a0792 | 2026-01-01 | Warnings, Adverse reactions | 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 410d5577-e50a-44f3-aaa8-fbf391a0c261 | 2025-12-30 | Warnings, Adverse reactions | 251872 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Chartwell RX, LLC | 42a969c3-1144-4151-9cf3-3e9bace6a380 | 2025-12-22 | Warnings, Adverse reactions | 251872 314200 6871619Q5X |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 51e4144a-489e-436c-609a-39305f8f56ba | 2025-12-22 | Warnings, Adverse reactions | 6871619Q5X |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | f39b3e7d-39d2-4c8a-9974-4ab885241880 | 2025-12-22 | Warnings, Adverse reactions | 6871619Q5X |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | QPharma Inc | b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6 | 2025-12-04 | Warnings, Adverse reactions | ANDA202882 314200 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | AvPAK | b9fa8381-b75e-b1cd-e053-2a95a90a9883 | 2025-12-03 | Warnings, Adverse reactions | 251872 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | QPharma Inc | fbd035d0-529c-6033-e053-6294a90abf07 | 2025-12-02 | Warnings, Adverse reactions | 314200 6871619Q5X |
| Pantoprazole sodium | PANTOPRAZOLE SODIUM | Ajanta Pharma USA Inc. | 90963a38-f629-45a4-bddd-9e13a55fe0f7 | 2025-11-26 | Warnings, Adverse reactions | 6871619Q5X |
| Pantoprazole Sodium | PANTOPRAZOLE | PHOENIX RX LLC | 440b9ae8-2fb8-5d35-e063-6294a90a82b6 | 2025-11-20 | Warnings, Adverse reactions | 251872 6871619Q5X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.