Trazodone Hydrochloride
- Product NDC
- 64725-0434
- 11-digit product format
- 647250434
- Labeler code
- 64725
- Product ID
- 64725-0434_476c6f63-97d9-4142-b778-58d72af4ab38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA071524
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 64725-0434 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 64725-0434 | 64725-0434-1 | I | Inactivated by FDA | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 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 | 64725-0434-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 64725-0434-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 64725-0434-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 64725-0434-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 64725-0434-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 64725-0434-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 64725-0434-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 64725-0434-1 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 64725-0434-1 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 64725-0434-1 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 64725-0434-1 | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071524-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071524-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A071524-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071524-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071524-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071524-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071524-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071524-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071524-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071524-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071524-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071524-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071524-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071524-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071524-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071524-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071524-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071524-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071524-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071524-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A071524-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A071524-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071524-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071524-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071524-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071524-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071524-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071524-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071524-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071524-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071524-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071524-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071524-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071524-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071524-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071524-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071524-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071524-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071524-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071524-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A071524-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A071524-001 | AB | 1 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac7a3d9b-58c0-4ffc-a3eb-ed863453525e | Product name | 1 | 20250730 |
| b2f15d64-48ea-ba98-af5c-91f410667b31 | Product name | 5 | 20250314 |
| d8e7f61b-4ab5-0dbe-2706-4e11b6079b87 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0434-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3738-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use TRAZODONE hydrochloride tablets USP safely and effectively. See full prescribing information for TRAZODONE hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0434-1 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | ACTIVE INGREDIENT | 6E8ZO8LRNM | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| TRAZODONE | ACTIVE MOIETY | YBK48BXK30 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0434 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140828_2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec.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 |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 7bba99e5-4096-4fcb-8591-dc4a9bfe975e | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | df17cec9-ad5e-4e57-8572-c927c9b955e2 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvKARE | b3723265-7455-c25c-e053-2a95a90a379b | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b617348c-cb19-45df-b313-4ea6af6f1dda | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Northwind Health Company, LLC | e07d7ee3-776d-1fa3-e053-2a95a90a7019 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d42fd0c8-3673-4f18-a6c0-cd276bbf9fef | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5ab590d8-225f-43f4-bb68-1f2c86f9a886 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 4006d439-e2de-4590-82e9-fc9d56e3ec1b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 203881a3-37d0-41dd-86c5-1e53fb784326 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | 071524 ANDA071524 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0434-1 | 64725043401 | 100 in 1 BOTTLE | Historical |