NDC 80425-0331-01 - Esomeprazole Magnesium 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
- 80425-0331
- Requested NDC
- 80425-0331-01
- Package NDCs from labels
- 80425-0331-1, 80425-0331-2, 80425-0331-3, 80425-0331-01
- 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 |
|---|---|---|---|
| Esomeprazole Magnesium 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 |
|---|---|---|---|---|---|---|
| 80425-0331-1 | Esomeprazole MagnesiumDR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 2 | |
| 80425-0331-2 | Esomeprazole MagnesiumDR | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 2 | |
| 80425-0331-3 | Esomeprazole MagnesiumDR | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0331 | ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_fab87a2d-79c8-6045-e053-6394a90a2368.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0331-1 | EA - Each | 80425-0331 | 09a6db3c-1ba1-41db-b733-8bb5688d40e8 | 1 | 2023-06-06 |
| 80425-0331-2 | EA - Each | 80425-0331 | b9ec7345-542f-4b24-8f5f-6fee820f3413 | 1 | 2023-06-06 |
| 80425-0331-3 | EA - Each | 80425-0331 | d7bd067b-5e67-4596-8a74-c7a10226c2c0 | 1 | 2023-06-06 |
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 |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Discount Drug Mart, Inc | 0d6e66c5-ca6d-5cda-72d7-9350dbd1eba0 | 2024-12-16 | Warnings | 606726 R6DXU4WAY9 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 3a879cfc-b0a4-48ca-aa6a-b5e9051601aa | 2024-12-12 | Warnings, Adverse reactions | 606726 R6DXU4WAY9 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | DISCOUNT DRUG MART, INC. | 144fcd6b-2b40-f84b-c559-07a847b27638 | 2024-11-30 | Warnings | 606726 R6DXU4WAY9 |
| esomeprazole | ESOMEPRAZOLE | Macleods Pharmaceuticals Limited | d68c9247-91c7-4e0f-adc4-2cfa7446580f | 2024-11-30 | Warnings, Adverse reactions | 606726 606730 |
| esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Zydus Lifesciences Limited | 6f314f5d-453c-4876-b9b8-20663008dfb1 | 2024-11-28 | 606726 606730 | |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Somerset Therapeutics, LLC | 02893318-e394-5a8e-e063-6394a90a885a | 2024-11-11 | Warnings, Adverse reactions | 606726 606730 R6DXU4WAY9 |
| esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Zydus Pharmaceuticals USA Inc. | c4b0571e-7b09-441b-90be-bc653806812b | 2024-11-11 | Warnings, Adverse reactions | 606726 606730 |
| Esomeprazole | ESOMEPRAZOLE MAGNESIUM | INNOVUS PHARMACEUTICALS, INC. | b3d10f0b-52af-408c-9b3d-f8f25f7c42bd | 2024-10-30 | Warnings | 606726 R6DXU4WAY9 |
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Advanced Rx of Tennessee, LLC | 25a48082-ca99-42a4-e063-6394a90ae559 | 2024-10-29 | Warnings, Adverse reactions | 606730 R6DXU4WAY9 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | A-S Medication Solutions | 42b8d3f5-d919-48dd-92e4-ed49488dd664 | 2024-10-21 | Warnings, Adverse reactions | ANDA211977 606730 R6DXU4WAY9 |
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES | Asclemed USA, Inc. | 85a963c1-9c13-4eb7-826b-08d5a991fe28 | 2024-10-04 | Warnings, Adverse reactions | 606726 606730 R6DXU4WAY9 |
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES | Proficient Rx LP | ad05cdde-a9e9-4442-80c4-1b02f5ebf6b4 | 2024-10-01 | Warnings, Adverse reactions | 606726 R6DXU4WAY9 |
| esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | f99f95a2-60e4-4781-80a9-e5b12897dff1 | 2024-09-03 | Warnings, Adverse reactions | 606730 R6DXU4WAY9 |
| topcare esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Topco Associates LLC | 86384845-0bea-490b-b04a-5770ef88b639 | 2024-09-01 | Warnings | 606726 |
| Good Sense Esomeprazole Magnesium | ESOMEPRAZOLE | L. Perrigo Company | 4a89b4b5-5c42-44ee-98a9-e26a237aaef7 | 2024-08-27 | Warnings | 606726 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 7778bf7c-52f7-44b3-ac2c-e5a25f6967b7 | 2024-08-23 | Warnings, Adverse reactions | ANDA211977 606726 R6DXU4WAY9 |
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES | Bryant Ranch Prepack | db8a346e-dba1-41bc-b122-a1de868ee91a | 2024-08-23 | Warnings, Adverse reactions | 606726 R6DXU4WAY9 |
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 192c63f0-25ac-410e-ae75-62e96cbf6f9d | 2024-08-15 | Warnings, Adverse reactions | 606730 R6DXU4WAY9 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 61cc0020-aab8-42a3-b0a6-93062f382c87 | 2024-08-12 | Warnings, Adverse reactions | ANDA211977 606730 R6DXU4WAY9 |
| esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 2f1b1a56-b6c4-4e30-a1f7-12701aa5a535 | 2024-08-08 | Warnings, Adverse reactions | 606726 R6DXU4WAY9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.