NDC 80425-0057-04 - Tramadol HCL
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
- 80425-0057
- Requested NDC
- 80425-0057-04
- Package NDCs from labels
- 80425-0057-5, 80425-0057-4, 80425-0057-1, 80425-0057-2, 80425-0057-3, 80425-0057-04
- Manufacturer
- Advanced Rx 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 |
|---|---|---|---|
| Tramadol HCL - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0057-1 | Tramadol HCL | 30 in 1 BOTTLE | TABLET, COATED | 30 | 9 | |
| 80425-0057-2 | Tramadol HCL | 60 in 1 BOTTLE | TABLET, COATED | 60 | 9 | |
| 80425-0057-3 | Tramadol HCL | 90 in 1 BOTTLE | TABLET, COATED | 90 | 9 | |
| 80425-0057-4 | Tramadol HCL | 15 in 1 BOTTLE | TABLET, COATED | 15 | 9 | |
| 80425-0057-5 | Tramadol HCL | 120 in 1 BOTTLE | TABLET, COATED | 120 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0057 | TRAMADOL HCL TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250101_af87fc31-07c2-b1f7-e053-2995a90a499f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0057-1 | EA - Each | 80425-0057 | 504be37b-91ad-4507-a4aa-1f8cd3a6f862 | 1 | 2023-03-13 |
| 80425-0057-2 | EA - Each | 80425-0057 | 4c02de54-897e-4e5b-ac17-54b2b024bb79 | 1 | 2023-03-13 |
| 80425-0057-3 | EA - Each | 80425-0057 | ad860459-e36b-4269-87a3-ee63a4811db7 | 1 | 2023-03-13 |
| 80425-0057-4 | EA - Each | 80425-0057 | 53aa85da-c9bb-42b1-93bb-fd4d2d165c85 | 1 | 2023-03-13 |
| 80425-0057-5 | EA - Each | 80425-0057 | 998304a3-5bc5-44c3-ab3d-2e3b4e522fae | 1 | 2023-03-13 |
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 |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 9f0e33bd-65f8-446a-886f-e7e16a142ce5 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 16053b28-c759-4914-93e6-2de0afe72445 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 42de8c3a-0441-5d46-e063-6294a90a2079 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 6bb5be12-59ff-40f4-9841-9c7ab93be2ea | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | cb05d615-918d-8104-e053-2995a90aa96b | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 552e5b32-accf-29dd-e063-6294a90a4fcf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Northwind Health Company, LLC | 552955e6-2bb3-8755-e063-6394a90ab21c | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Coupler LLC | 54d74939-301b-e603-e063-6394a90a3b03 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | ANDA076003 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 515baa9a-b226-4bbe-be87-f9befdf1c9e1 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 5199132e-745e-46a0-8068-e06d1bca5c61 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 855905c7-1481-4b2d-a318-3254ad8ed73c | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | aefc85bc-0820-4aee-8d94-313c5f1658f5 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | 6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | ANDA076003 835603 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | ccf465b5-8ef8-4445-a0d4-23b5cf13188c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 66359f41-9999-4cb8-b632-1fe2ec1e60b2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 43fe10b2-17a4-4dc2-9a48-2378547b61fd | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | f2f421ab-35ae-7637-e053-2995a90a40e0 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 674803a0-4cf5-4416-a5e3-c1a1e332cdcd | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | acd5d8e0-a4cc-4654-ae04-faff347a60ca | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 007bf37f-0e46-426a-ac8c-be63d4b7414c | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |