Trazodone Hydrochloride
- Product NDC
- 71335-0343
- Requested package NDC
- 71335-0343-6
- 11-digit product format
- 713350343
- Labeler code
- 71335
- Product ID
- 71335-0343_ebafe312-212f-45bb-842c-c9712fe06e0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA071196
- Marketing category
- ANDA
- Marketing start
- 2008-11-17
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71335-0343 | 71335-0343-6 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071196-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 |
| A071196-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | |
| A071196-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071196-001 | AB |
| A071196-002 | AB |
| A071196-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A071196-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071196-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071196-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071196-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071196-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071196-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071196-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071196-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071196-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071196-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071196-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071196-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071196-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071196-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071196-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071196-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | dc1f347e-1acb-4c06-b36e-f15fecb7ac93 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 071196 ANDA071196 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Apotex Corp | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 071196 ANDA071196 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | 071196 ANDA071196 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 9c4da6ad-d4d1-4e8c-918d-8ac48512a93f | 2020-06-30 | Boxed warning, Warnings, Adverse reactions | 071196 ANDA071196 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0343-6 | 71335034306 | 10 TABLET in 1 BOTTLE (71335-0343-6) | 10 tablet | 2016-01-22 | 0000-00-00 | No | No | Current |