Trazodone Hydrochloride
- Product NDC
- 63629-8139
- 11-digit product format
- 636298139
- Labeler code
- 63629
- Product ID
- 63629-8139_6524f8e0-4561-4c5e-a56f-a561399af176
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205253
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 63629-8139 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63629-8139 | 63629-8139-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-8139 | 63629-8139-2 | D | Discontinued by firm | 2026-08-17 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-8139-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-8139-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-8139-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-8139-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-8139-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-8139-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-8139-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-8139-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-8139-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-8139-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-8139-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-8139-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-8139-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-8139-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-8139-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-8139-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-8139-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-8139-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-8139-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-8139-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-8139-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-8139-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-8139-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-8139-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205253-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205253-001 | AB |
| A205253-002 | AB |
| A205253-003 | AB |
| A205253-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205253-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205253-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205253-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205253-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205253-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205253-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205253-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205253-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205253-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205253-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205253-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205253-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205253-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | f715085a-be56-497e-ad92-9fec3aba70b5 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmceuticals,Inc. | 81a5b557-06f6-2470-e053-2991aa0a64fd | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | a31d59ed-5949-4f85-8b73-3bfd7f72d5b8 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 2863317d-657b-4dc6-81fb-b7158ea03498 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 007f38e0-653b-43e4-a1c1-b59997b2762a | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 68bcae4b-f4c3-4d28-af76-d182b707fc73 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 614f2c6e-0bb7-43e0-85d8-5eef8eeae208 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 04c287ca-5efa-469d-ab39-ff16d9b1e0b3 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 6aaf08aa-9aa3-aabd-e053-2a91aa0a86d1 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 0545507a-5c11-4451-872a-d2f7f0aaecd4 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 51e1ef06-d2c8-46db-a2b4-f20d4cc1abf3 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 297cdf27-5b6e-4665-93f9-8fc6aef483a0 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Zydus Lifesciences Limited | 43d4be17-5fae-4326-a5c4-9e25e2db6a43 | 2026-01-23 | 205253 ANDA205253 | |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 4fcd25d5-e34f-4eea-aeff-aa442651e681 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvPAK | 9f1c2bf1-5204-7306-e053-2a95a90a9903 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 353e66cc-98ca-4500-97e7-00f23f122349 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b716575a-5b96-49c5-bcb2-56b05fbb7920 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | 094ca37b-3ae2-4889-9536-e7e5f20e3105 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | bb3ecde6-72ca-450c-ba88-9cf45c808d90 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-8139-1 | 63629813901 | 30 TABLET in 1 BOTTLE (63629-8139-1) | 30 tablet | 2019-07-15 | 0000-00-00 | No | No | Current |
| 63629-8139-2 | 63629813902 | 90 TABLET in 1 BOTTLE (63629-8139-2) | 90 tablet | 2019-08-28 | 0000-00-00 | No | No | Current |