NDC 80425-0189-01 - Diclofenac 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
- 80425-0189
- Requested NDC
- 80425-0189-01
- Package NDCs from labels
- 80425-0189-1, 80425-0189-2, 80425-0189-3, 80425-0189-01
- 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 |
|---|---|---|---|
| Diclofenac 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 |
|---|---|---|---|---|---|---|
| 80425-0189-1 | Diclofenac SodiumDR | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 6 | |
| 80425-0189-2 | Diclofenac SodiumDR | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 6 | |
| 80425-0189-3 | Diclofenac SodiumDR | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0189 | DICLOFENAC SODIUM DR (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250101_d424ab84-2aaa-38a9-e053-2a95a90adde9.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0189-1 | EA - Each | 80425-0189 | 1cc1ed3c-bfe6-449b-8220-36962f0168af | 1 | 2023-03-13 |
| 80425-0189-2 | EA - Each | 80425-0189 | b2b4c1f7-3353-4bcb-947e-56e9782f23ed | 1 | 2023-04-07 |
| 80425-0189-3 | EA - Each | 80425-0189 | 0d40ec80-d802-40a2-b8c1-d0f7c388ca59 | 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 |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 005299ac-b6de-511f-e063-6294a90a29e0 | 2024-07-29 | Warnings | QTG126297Q |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals, Inc. | 4b44ac98-225c-1739-e054-00144ff88e88 | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | ANDA075185 855906 QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | abacf60f-0410-e6da-e053-2995a90a413c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC | Amneal Pharmaceuticals LLC | 78873f83-cea9-44d4-8ad4-8cb9257e5c7f | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 1d4d6370-2b45-fa6d-e063-6294a90a4a67 | 2024-07-11 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | NuCare Pharmaceuticals,Inc. | 0326ea5b-3e1a-dee2-e063-6294a90a13b8 | 2024-07-09 | Warnings | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | Aurohealth LLC | 81e964ff-6622-4054-bf01-6ed6eef6778f | 2024-07-06 | Warnings | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 898558e7-17f8-40cd-9dfc-67ddd64a5a42 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | KROGER COMPANY | 15e59aac-a642-91e4-e063-6294a90a1175 | 2024-06-28 | Warnings | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 1be247b8-dafd-ddf9-e063-6294a90aa9e1 | 2024-06-27 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Curist Arthritis Relief | DICLOFENAC SODIUM | Little Pharma, Inc. | e638a98e-e6d7-36ed-e053-2995a90af2ca | 2024-06-21 | Warnings | QTG126297Q |
| diclofenac sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 8721da56-0f8a-5903-e053-2991aa0a61b5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 8bda6135-c957-6b4e-e053-2995a90a0cb5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | ANDA075185 855926 QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 5d74488c-e092-415d-b19b-05318380d9b1 | 2024-06-10 | Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 629b77cf-f825-8640-e053-2991aa0a10a8 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | ANDA075185 855906 QTG126297Q |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 7bf19e84-4f75-4d5c-9927-99220c58b572 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | ANDA075185 855926 QTG126297Q |
| Diclofenac Sodium Topical Solution | DICLOFENAC SODIUM TOPICAL SOLUTION | Direct_Rx | 15c2cd6d-b7c2-d927-e063-6394a90aa63e | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL | Medsource Pharmaceuticals | 1495ed53-0489-a465-e063-6394a90af68d | 2024-03-26 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Lupin Pharmaceuticals,Inc. | 7559928e-eeb8-47e8-8a55-d59e06bbc737 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | Simple Diagnostics | 13925cd5-e121-80d2-e063-6394a90af9a9 | 2024-03-19 | Warnings | QTG126297Q |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.