Trazodone Hydrochloride
- Product NDC
- 87441-080
- 11-digit product format
- 874410080
- Labeler code
- 87441
- Product ID
- 87441-080_562fa89f-5b79-8bdb-e063-6294a90a3014
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Solutions, Inc.
- Application
- ANDA218988
- Marketing category
- ANDA
- Marketing start
- 2026-07-09
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218988-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | |
| A218988-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | |
| A218988-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | |
| A218988-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218988-001 | AB |
| A218988-002 | AB |
| A218988-003 | AB |
| A218988-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-08 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218988-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218988-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218988-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218988-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218988-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218988-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218988-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218988-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218988-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218988-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218988-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218988-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218988-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218988-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218988-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218988-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trazodone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRAZODONE HYDROCHLORIDE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6E8ZO8LRNM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 856373 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 562fa890-0a39-9361-e063-6294a90a1bb5 | Available on FDA.report |
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. | 3b2e61b0-414c-48ae-9e13-06470c302c67 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 51012256-b249-ccbb-e063-6394a90af4fa | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 5bc5f266-6c0e-4b9a-b6e0-ea694928b948 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 562fa890-0a39-9361-e063-6294a90a1bb5 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 87441-080 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Coupler LLC | 31356804-951b-68c7-e063-6294a90a6410 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Coupler LLC | 2c7dca0c-8313-7d85-e063-6294a90aca61 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | 218988 ANDA218988 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87441-080-01 | 87441008001 | 30 TABLET in 1 BLISTER PACK (87441-080-01) | 30 tablet | 2026-07-09 | No | No | Current |