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 | 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 |
| Tramadol/APAP | TRAMADOL/APAP | Direct_rx | 4e40f55e-1d8e-ce2f-e063-6294a90a7bec | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | a77b0dba-8ac7-418a-b435-16a0e6c22804 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | b76c1366-f6c0-42ad-bb19-2b72a91490e4 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | c83366d9-db60-45eb-9c2b-a2c58d45c82c | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | a886d551-6b57-4d9d-87f4-e1366385c7fd | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | b5852b90-e415-47ef-8f73-87266b58e033 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 835603 2179635 9N7R477WCK |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 46bb9ae6-3ee8-463c-badb-c7a45a89b84b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | 4a525cf7-2c0c-47c6-aed3-3a395a7120ec | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | f9282800-fde7-477a-8b8f-59617ec26f73 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | 18d9e3e4-5892-43b8-b211-3ef3393ad946 | 2026-02-15 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 24aea499-c6f1-9200-e063-6394a90a9db6 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride Extended-Release | TRAMADOL HYDROCHLORIDE | Trigen Laboratories, LLC | c0bc7218-3fd0-4646-96f4-25355fc84aa9 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | AvPAK | 244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0 | 2026-01-12 | Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advagen Pharma Limited | 93b12089-3a0f-4b57-abb1-2429cf31995d | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | ANDA208708 72888-080 2670390 835603 2692878 2179635 47c74a4e-51f2-e294-e063-6394a90aa70b 93b12089-3a0f-4b57-abb1-2429cf31995d 9N7R477WCK |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Amneal Pharmaceuticals of New York LLC | d51600e2-2f73-483c-9b2e-f142bafff16d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 9N7R477WCK |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 561f00e5-f69c-4369-ae4d-5eff86c4499f | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 835603 9N7R477WCK |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.