TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Product NDC
- 57664-537
- Requested package NDC
- 57664-537-13
- 11-digit product format
- 576640537
- Labeler code
- 57664
- Product ID
- 57664-537_0aec7684-04b3-485d-a030-3ca9843d097f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077184
- Marketing category
- ANDA
- Marketing start
- 2005-12-16
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 57664-537 | 57664-537-13 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | 2005-12-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077184-001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 325MG;37.5MG | TABLET / ORAL | AB | 2005-12-16 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077184-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077184-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077184-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077184-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077184-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077184-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077184-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077184-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077184-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077184-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077184-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077184-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077184-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077184-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077184-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077184-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077184-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077184-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077184-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077184-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077184-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077184-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077184-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077184-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077184-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077184-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077184-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077184-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077184-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077184-001 | AB | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-537-13 | EA - Each | 57664-537 | 011af264-5329-4815-8f45-2df84c784cef | 1 | 2012-07-24 |
| 57664-537-18 | EA - Each | 57664-537 | 54f2dc2c-6fe9-45bf-ac52-0bf4d52e307b | 1 | 2012-07-24 |
| 57664-537-88 | EA - Each | 57664-537 | 1d904019-70d6-42ba-8910-dfe1221b015d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | ea9cc585-c70d-4d82-be02-7b7fe7153cdd | 8 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | ea9cc585-c70d-4d82-be02-7b7fe7153cdd | 8 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | ea9cc585-c70d-4d82-be02-7b7fe7153cdd | 8 |
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce | 4 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | 62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce | 4 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | 62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce | 4 |
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | e5914c36-ff79-4fad-b454-4414443cc230 | 3 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | e5914c36-ff79-4fad-b454-4414443cc230 | 3 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | e5914c36-ff79-4fad-b454-4414443cc230 | 3 |
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | e8a55896-67f8-3d23-e053-2a95a90a654a | 1 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | e8a55896-67f8-3d23-e053-2a95a90a654a | 1 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | e8a55896-67f8-3d23-e053-2a95a90a654a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57664-537-13 | 57664053713 | 500 TABLET, FILM COATED in 1 BOTTLE (57664-537-13) | 2005-12-16 | 0000-00-00 | No | No | Current |