TRAMADOL HYDROCHLORIDE
- Product NDC
- 68788-8367
- 11-digit product format
- 687888367
- Labeler code
- 68788
- Product ID
- 68788-8367_1ba78592-5daf-4d80-ae65-c71d84b7a06e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 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 |
|---|---|---|---|---|---|---|---|
| A200503-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 |
| A200503-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | |
| A200503-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200503-001 | AB1 |
| A200503-002 | AB1 |
| A200503-003 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A200503-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | AB1 | 1 | b8a1b40f171c… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-002 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-003 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200503-001 | AB1 | 1 | 5c6f7cd8ea54… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRAMADOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9N7R477WCK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 833709 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c30f6e9e-8014-40fc-9615-a6b8654137c1 | 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 |
|---|---|---|---|---|---|---|
| 68788-8367-2 | TRAMADOL HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | 3 | |
| 68788-8367-3 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 3 | |
| 68788-8367-6 | TRAMADOL HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 3 | |
| 68788-8367-9 | TRAMADOL HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8367-2 | EA - Each | 68788-8367 | 8318b3a3-4d93-41d2-9371-ad494489b3b0 | 1 | 2023-03-13 |
| 68788-8367-3 | EA - Each | 68788-8367 | 886b3b96-1e36-457b-8514-b09a566905fe | 1 | 2023-03-13 |
| 68788-8367-6 | EA - Each | 68788-8367 | 64fb2a71-b4f3-4e19-99a3-11003e153fb8 | 1 | 2023-03-13 |
| 68788-8367-9 | EA - Each | 68788-8367 | 39407641-8453-4957-824c-15c1731f1ec4 | 1 | 2023-03-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8367 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 2 | Current NDC, 4 package rows | 20240822_c30f6e9e-8014-40fc-9615-a6b8654137c1.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 HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 16053b28-c759-4914-93e6-2de0afe72445 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 6bb5be12-59ff-40f4-9841-9c7ab93be2ea | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | acd5d8e0-a4cc-4654-ae04-faff347a60ca | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | b76c1366-f6c0-42ad-bb19-2b72a91490e4 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 46bb9ae6-3ee8-463c-badb-c7a45a89b84b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 83367367-5654-4078-831a-69ade48bc795 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | c30f6e9e-8014-40fc-9615-a6b8654137c1 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 68788-8367 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | c28c98ac-7e07-46a5-8f34-57c008308fba | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Coupler LLC | 2f23ba6c-89d2-cc42-e063-6394a90aee0a | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL ER | Direct_Rx | 09a7af47-423a-1e8b-e063-6394a90a99ef | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | b3c702f7-0a8c-a52b-e053-2995a90a6df3 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | bf51a3af-cbc6-3021-e053-2a95a90a80b7 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | f8c5328d-7b47-626e-e053-6294a90a04b3 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 68484531-f908-473f-a422-f37234de9691 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 7e421fb6-737c-49b3-b299-50511e281a4d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | b4cd4b64-7db5-da44-e053-2995a90a8953 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HCL ER | TRAMADOL HCL | DIRECT RX | 5285f056-c32c-4e7a-bec6-3a726aa23d5a | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 8cc09b31-6067-44ec-8aba-ea7bb1a1f448 | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | b2f3f007-6dda-4532-9f7f-d93f6e65254c | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93c9c960-afbf-6d3d-e053-2995a90a8d15 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833709 | traMADol HCl 100 MG 24HR Extended Release Oral Tablet | PSN | c30f6e9e-8014-40fc-9615-a6b8654137c1 | 3 |
| 833709 | 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet | SCD | c30f6e9e-8014-40fc-9615-a6b8654137c1 | 3 |
| 833709 | tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet | SY | c30f6e9e-8014-40fc-9615-a6b8654137c1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68788-8367-2 | 68788836702 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-2) | 2023-02-01 | No | No | Current |
| 68788-8367-3 | 68788836703 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-3) | 2023-02-01 | No | No | Current |
| 68788-8367-6 | 68788836706 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-6) | 2023-02-01 | No | No | Current |
| 68788-8367-9 | 68788836709 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-9) | 2023-02-01 | No | No | Current |