Trazodone Hydrochloride
- Product NDC
- 50111-434
- 11-digit product format
- 501110434
- Labeler code
- 50111
- Product ID
- 50111-434_b39d3ec4-9b53-48a1-84c8-2b418c2d09f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA071524
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 2022-07-31
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 product | product | 50111-434 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 50111-434 | 50111-434-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50111-434 | 50111-434-02 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50111-434 | 50111-434-03 | D | Discontinued by firm | 2026-07-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A071524-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1987-12-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A071524-001 | AB | 1 | a50c72e98297… |
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 | 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 | REMEDYREPACK INC. | 7bba99e5-4096-4fcb-8591-dc4a9bfe975e | 2026-04-22 | 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 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50111-434-01 | EA - Each | 50111-434 | 464771f4-4072-4191-889f-0ffcc2b1444e | 1 | 2012-07-24 |
| 50111-434-02 | EA - Each | 50111-434 | 4d5c2ffc-489e-4840-af93-05e7c1467c1d | 1 | 2012-07-24 |
| 50111-434-03 | EA - Each | 50111-434 | dbd3de61-27a6-4e94-90f8-c9f20a132a71 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | d8096ecd-7c99-4db6-915d-2c5dd371a8a4 | 21 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | d8096ecd-7c99-4db6-915d-2c5dd371a8a4 | 21 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | d8096ecd-7c99-4db6-915d-2c5dd371a8a4 | 21 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | d8096ecd-7c99-4db6-915d-2c5dd371a8a4 | 21 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 8c859876-6b45-45b3-9eb2-5c7a5ea7a26f | 7 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 8c859876-6b45-45b3-9eb2-5c7a5ea7a26f | 7 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 8c859876-6b45-45b3-9eb2-5c7a5ea7a26f | 7 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 8c859876-6b45-45b3-9eb2-5c7a5ea7a26f | 7 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 1e3fdd78-63e8-44da-92d1-bf1c95cd12c2 | 6 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 1e3fdd78-63e8-44da-92d1-bf1c95cd12c2 | 6 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | eceb9837-9cf1-4b48-aad7-ed3c905d3a08 | 1 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 28080f0c-0b6c-4d95-8a53-6474bb876b0e | 1 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 29e4012e-05bb-4aff-9f20-f0c17a06a29e | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 28080f0c-0b6c-4d95-8a53-6474bb876b0e | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 29e4012e-05bb-4aff-9f20-f0c17a06a29e | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 28080f0c-0b6c-4d95-8a53-6474bb876b0e | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | eceb9837-9cf1-4b48-aad7-ed3c905d3a08 | 1 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 28080f0c-0b6c-4d95-8a53-6474bb876b0e | 1 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50111-434-01 | 50111043401 | 100 TABLET in 1 BOTTLE (50111-434-01) | 100 tablet | 1990-09-30 | 2022-07-31 | No | No | Current |
| 50111-434-02 | 50111043402 | 500 TABLET in 1 BOTTLE (50111-434-02) | 500 tablet | 1990-09-30 | 2022-07-31 | No | No | Current |
| 50111-434-03 | 50111043403 | 1000 TABLET in 1 BOTTLE (50111-434-03) | 1000 tablet | 1990-09-30 | 2022-06-30 | No | No | Current |