Application 021692
- Type
- NDA
- Sponsor
- VALEANT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 002 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Yes | No |
| 003 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021692-001 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |
| N021692-002 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |
| N021692-003 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 |
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| 2026-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 301d65b070ca… |
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 | a77b0dba-8ac7-418a-b435-16a0e6c22804 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | b76c1366-f6c0-42ad-bb19-2b72a91490e4 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | a886d551-6b57-4d9d-87f4-e1366385c7fd | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | b5852b90-e415-47ef-8f73-87266b58e033 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 46bb9ae6-3ee8-463c-badb-c7a45a89b84b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | 4a525cf7-2c0c-47c6-aed3-3a395a7120ec | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | f9282800-fde7-477a-8b8f-59617ec26f73 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | 18d9e3e4-5892-43b8-b211-3ef3393ad946 | 2026-02-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 24aea499-c6f1-9200-e063-6394a90a9db6 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride Extended-Release | TRAMADOL HYDROCHLORIDE | Trigen Laboratories, LLC | c0bc7218-3fd0-4646-96f4-25355fc84aa9 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advagen Pharma Limited | 93b12089-3a0f-4b57-abb1-2429cf31995d | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 561f00e5-f69c-4369-ae4d-5eff86c4499f | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| ConZip | TRAMADOL HYDROCHLORIDE | Vertical Pharmaceuticals, LLC | a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Northwind Health Company, LLC | 1b5360f8-3e95-a047-e063-6294a90a7315 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 3d719560-7449-f970-e063-6294a90a9bd8 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | a07ed444-54e4-4d45-b6a1-6ea2f6dedc61 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | dc420d50-6192-482d-b3da-3be55870a79a | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 004de5a4-80f8-4040-a6ea-be5e99352a36 | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10147-0901 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 10147-0902 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 10147-0903 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 21695-292 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-563 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-913 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 50458-653 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
| 50458-655 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
| 50458-657 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49628 | SUPPL | 2017-08-30 |
| 49600 | SUPPL | 2017-08-30 |
| 49599 | SUPPL | 2017-08-30 |
| 46351 | SUPPL | 2016-12-21 |
| 46350 | SUPPL | 2016-12-21 |
| 46292 | SUPPL | 2016-12-20 |
| 46291 | SUPPL | 2016-12-20 |
| 5999 | SUPPL | 2009-03-19 |
| 37471 | SUPPL | 2008-02-25 |
| 15999 | SUPPL | 2008-02-25 |
| 28391 | SUPPL | 2008-02-22 |
| 28390 | SUPPL | 2008-02-22 |
| 5998 | SUPPL | 2006-08-07 |
| 15998 | SUPPL | 2006-08-04 |
| 42273 | ORIG | 2006-07-25 |
| 5997 | SUPPL | 2006-06-06 |
| 15997 | ORIG | 2005-09-09 |
| 5996 | ORIG | 2005-09-09 |