Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 71335-0111
- 11-digit product format
- 713350111
- Labeler code
- 71335
- Product ID
- 71335-0111_1c50d830-dc13-481d-b224-0260a6447d12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325; 37.5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090485-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | RS | 2009-12-09 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090485-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2009-12-09 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090485-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090485-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090485-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090485-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090485-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090485-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090485-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090485-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090485-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090485-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090485-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090485-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090485-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090485-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090485-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090485-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090485-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090485-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090485-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090485-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090485-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090485-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090485-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090485-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090485-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090485-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090485-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090485-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090485-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090485-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090485-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090485-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090485-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090485-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090485-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090485-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090485-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090485-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090485-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090485-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 325 mg/1 |
| ACETAMINOPHEN | 37.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9N7R477WCK | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 836395 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 43d017e1-6ae6-7555-71d1-c249236d6f26 | Product name | 4 | 20251117 |
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| c563c906-2606-457c-bb1b-5a623daed55b | Product name | 1 | 20210511 |
| 43a9f8f9-34aa-8ae8-719e-5489454f7720 | Product name | 5 | 20200123 |
| abd2f6f2-3fa7-4571-af8a-d67f89bdcb75 | Product name | 1 | 20190927 |
| 377068df-225f-7318-a910-a1987cdfa361 | Product name | 3 | 20170608 |
| 9457302e-0ca3-d9ff-0863-1b24b6107218 | Product name | 1 | 20140508 |
| d5c49867-1fe9-7a44-3319-814417011d51 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-0111-1 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 71335-0111-2 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | 9 | |
| 71335-0111-3 | Tramadol Hydrochloride and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | 9 | |
| 71335-0111-4 | Tramadol Hydrochloride and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | 9 | |
| 71335-0111-5 | Tramadol Hydrochloride and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | 9 | |
| 71335-0111-6 | Tramadol Hydrochloride and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | 9 | |
| 71335-0111-7 | Tramadol Hydrochloride and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 9 | |
| 71335-0111-8 | Tramadol Hydrochloride and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0111-1 | EA - Each | 71335-0111 | fdb57bd8-0e9a-44e1-90fe-2ea469b740d9 | 1 | 2018-03-08 |
| 71335-0111-2 | EA - Each | 71335-0111 | dcee3500-ead3-42ca-a666-c5b3a9149f36 | 1 | 2018-03-08 |
| 71335-0111-3 | EA - Each | 71335-0111 | 47265065-0b0c-4b97-bc92-d71d3526ac85 | 1 | 2018-03-08 |
| 71335-0111-4 | EA - Each | 71335-0111 | af9b106e-f6ad-4023-b504-86cc9a6fbd84 | 1 | 2018-03-08 |
| 71335-0111-5 | EA - Each | 71335-0111 | bcf7be74-e0a4-434e-93dd-f20b831749ed | 1 | 2018-03-08 |
| 71335-0111-6 | EA - Each | 71335-0111 | 6a7718c4-e277-42d5-bc52-fceeb463a940 | 1 | 2018-03-08 |
| 71335-0111-7 | EA - Each | 71335-0111 | 2bd90204-c16f-4d96-9764-d4d4bd626a38 | 1 | 2018-03-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0111 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK] | 9 | Current NDC, Legacy NDC, 8 package rows | 20240901_f33fcd05-2c95-48dd-884b-5ed9c25c2ccf.zip |
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/APAP | TRAMADOL/APAP | Direct_rx | 4e40f55e-1d8e-ce2f-e063-6294a90a7bec | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 090485 ANDA090485 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | AvPAK | 244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0 | 2026-01-12 | Warnings, Adverse reactions | 090485 ANDA090485 |
| 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 | 090485 ANDA090485 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 96094578-5348-4955-8e91-1c9163315d5a | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 090485 ANDA090485 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 090485 ANDA090485 71335-0111 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Asclemed USA, Inc. | 52693021-f60f-43bc-9b05-43db18621346 | 2022-01-14 | Boxed warning, Warnings, Adverse reactions | 090485 ANDA090485 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Proficient Rx LP | 1ad89537-3e59-438c-b646-b3c93b790853 | 2021-01-01 | Warnings, Adverse reactions | 090485 ANDA090485 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 9 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 9 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | f33fcd05-2c95-48dd-884b-5ed9c25c2ccf | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0111-1 | 71335011101 | 30 TABLET in 1 BOTTLE (71335-0111-1) | 30 tablet | 2021-03-17 | 0000-00-00 | No | No | Current |
| 71335-0111-2 | 71335011102 | 60 TABLET in 1 BOTTLE (71335-0111-2) | 60 tablet | 2021-04-14 | 0000-00-00 | No | No | Current |
| 71335-0111-3 | 71335011103 | 90 TABLET in 1 BOTTLE (71335-0111-3) | 90 tablet | 2021-08-20 | 0000-00-00 | No | No | Current |
| 71335-0111-4 | 71335011104 | 120 TABLET in 1 BOTTLE (71335-0111-4) | 120 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 71335-0111-5 | 71335011105 | 20 TABLET in 1 BOTTLE (71335-0111-5) | 20 tablet | 2021-04-14 | 0000-00-00 | No | No | Current |
| 71335-0111-6 | 71335011106 | 40 TABLET in 1 BOTTLE (71335-0111-6) | 40 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 71335-0111-7 | 71335011107 | 100 TABLET in 1 BOTTLE (71335-0111-7) | 100 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 71335-0111-8 | 71335011108 | 15 TABLET in 1 BOTTLE (71335-0111-8) | 15 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |