NDC 80425-0274-01 - Tramadol Hydrochloride
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
- 80425-0274
- Requested NDC
- 80425-0274-01
- Package NDCs from labels
- 80425-0274-1, 80425-0274-2, 80425-0274-3, 80425-0274-4, 80425-0274-5, 80425-0274-6, 80425-0274-7, 80425-0274-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-09-09
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Tramadol Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-09-09 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0274-1 | Tramadol Hydrochloride | 15 in 1 BOTTLE | TABLET, COATED | 15 | 3 | |
| 80425-0274-2 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | 3 | |
| 80425-0274-3 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | 3 | |
| 80425-0274-4 | Tramadol Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | 3 | |
| 80425-0274-5 | Tramadol Hydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | 3 | |
| 80425-0274-6 | Tramadol Hydrochloride | 40 in 1 BOTTLE | TABLET, COATED | 40 | 3 | |
| 80425-0274-7 | Tramadol Hydrochloride | 180 in 1 BOTTLE | TABLET, COATED | 180 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0274 | TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, 7 package rows | 20240910_f44c53ec-26ea-d272-e053-2a95a90a5e59.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0274-1 | EA - Each | 80425-0274 | 398555b3-0411-47e6-9afb-1aebc5e48194 | 1 | 2023-04-07 |
| 80425-0274-2 | EA - Each | 80425-0274 | 5a329e9a-dd9d-46d4-9b10-8def9a2acc19 | 1 | 2023-04-07 |
| 80425-0274-3 | EA - Each | 80425-0274 | 7b68ac6b-df12-4650-a322-60af28fd374f | 1 | 2023-04-07 |
| 80425-0274-4 | EA - Each | 80425-0274 | b5316944-76e0-4461-a650-fa097b349673 | 1 | 2023-04-07 |
| 80425-0274-5 | EA - Each | 80425-0274 | 809f47ab-f58f-44b4-bed7-4b231ac0d996 | 1 | 2023-04-07 |
| 80425-0274-6 | EA - Each | 80425-0274 | d94d1f4f-7837-432c-8290-0aa300c428e6 | 1 | 2023-04-07 |
| 80425-0274-7 | EA - Each | 80425-0274 | 0429d619-0f6b-4a38-a6c3-604e9aeb1002 | 1 | 2024-07-12 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 27460cc6-0782-7838-e063-6394a90a19f1 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 6ebc5864-c222-4400-a9b2-f66fd6fb0da6 | 2024-11-04 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| TRAMADOL HCL ER | TRAMADOL HCL | DIRECT RX | 5285f056-c32c-4e7a-bec6-3a726aa23d5a | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 1cd3caee-bf54-7aba-e063-6394a90ad8cb | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f44c53ec-26ea-d272-e053-2a95a90a5e59 | 2024-09-09 | Boxed warning, Warnings, Adverse reactions | ANDA208708 80425-0274-5 80425-0274-3 80425-0274-2 80425-0274-6 80425-0274-4 80425-0274-7 80425-0274-1 80425-0274 80425027401 835603 21b29899-296b-3c78-e063-6294a90a1e5a f44c53ec-26ea-d272-e053-2a95a90a5e59 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 8cc09b31-6067-44ec-8aba-ea7bb1a1f448 | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | b2f3f007-6dda-4532-9f7f-d93f6e65254c | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93c9c960-afbf-6d3d-e053-2995a90a8d15 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 2236031d-8596-4c21-8b16-83aa3e4122c1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93e129c8-64c4-1f6d-e053-2a95a90ac1f8 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | e90d4ef3-8b90-41b7-bf96-340852e89b5f | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Medsource Pharmaceuticals | 12f113b3-d6b1-a7b0-e063-6294a90a999d | 2024-03-05 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Medsource Pharmaceuticals | 1278980b-4068-df57-e063-6394a90a8742 | 2024-02-28 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3e0ccb95-3e8e-477c-b4d2-6060ee05f930 | 2023-12-11 | Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc | 2023-02-15 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | TruPharma, LLC | aea56ff9-94ac-47a8-8f15-8790d538973b | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 0bff5535-0239-409e-8a2a-99d5ba38cca3 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 00b7f61b-5173-43e6-a3f9-d2efbda40c19 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 2022-07-25 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.