Trazodone Hydrochloride
- Product NDC
- 50111-441
- Requested package NDC
- 50111-441-01
- 11-digit product format
- 501110441
- Labeler code
- 50111
- Product ID
- 50111-441_2f6356fb-56c5-4b3a-92ec-c881765bfc01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA071525
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 2021-10-31
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 150 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 package | package | 50111-441 | 50111-441-01 | 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 |
|---|---|---|---|---|---|---|---|
| A071525-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1988-03-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071525-001 | 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 | A071525-001 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1988-03-09 | 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 | A071525-001 | 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 | 310c4b81-d2cf-4014-873d-e71d036105de | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 071525 ANDA071525 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvKARE | a382ac4d-9ab9-796a-e053-2a95a90a2c26 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 071525 ANDA071525 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9b022ae9-dd52-43ae-804b-ddf8e7cfd530 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 071525 ANDA071525 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 4006d439-e2de-4590-82e9-fc9d56e3ec1b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 071525 ANDA071525 |
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 |
|---|---|---|---|---|---|
| 50111-441-01 | EA - Each | 50111-441 | 40fe84ed-e2e6-48e1-9039-fc77ad1fa22d | 1 | 2012-07-24 |
| 50111-441-02 | EA - Each | 50111-441 | 03d7641f-25c2-44a3-a439-458471d6e8e8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 6963a2cc-1c0b-4795-acb4-024488d517ce | 9 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 6963a2cc-1c0b-4795-acb4-024488d517ce | 9 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 6963a2cc-1c0b-4795-acb4-024488d517ce | 9 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 6963a2cc-1c0b-4795-acb4-024488d517ce | 9 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 29c443fc-8ef6-4778-8d6a-ad14181ef8de | 7 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 29c443fc-8ef6-4778-8d6a-ad14181ef8de | 7 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | e1ae415e-daf6-4b23-a545-e71a8acba1f6 | 3 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | e1ae415e-daf6-4b23-a545-e71a8acba1f6 | 3 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 2 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 6f43cdc2-4f8e-4a5f-976a-d3aaac65593d | 2 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | df555ed8-2d8c-45fd-8bf1-aa72c49090c0 | 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 |
| 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 | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | af82c9b0-1c3a-407a-aa5d-f15b9217b5c6 | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 10124262-e443-49a5-a1cc-8cc34c74d953 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | af82c9b0-1c3a-407a-aa5d-f15b9217b5c6 | 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 | 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 |
|---|---|---|---|---|---|---|---|---|
| 50111-441-01 | 50111044101 | 100 TABLET in 1 BOTTLE (50111-441-01) | 100 tablet | 1990-09-30 | 2021-09-30 | No | No | Current |