Trazodone Hydrochloride
- Product NDC
- 60429-188
- 11-digit product format
- 604290188
- Labeler code
- 60429
- Product ID
- 60429-188_ac13ccbd-7741-9bf5-e053-2995a90a1384
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA071196
- Marketing category
- ANDA
- Marketing start
- 1987-03-25
- 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
- 2021-12-31
- 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 product | product | 60429-188 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 60429-188 | 60429-188-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 60429-188 | 60429-188-05 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 60429-188 | 60429-188-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 60429-188 | 60429-188-60 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 60429-188 | 60429-188-90 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A071196-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | RS | 1987-03-25 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A071196-002 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1999-04-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A071196-003 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-04-26 | 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 | A071196-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A071196-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A071196-003 | 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 | 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60429-188-01 | EA - Each | 60429-188 | 986ced46-3a85-49e9-86d7-72c706d540ef | 1 | 2012-07-24 |
| 60429-188-05 | EA - Each | 60429-188 | 8a56aeb0-312b-4443-a9d3-c0a69ae02228 | 1 | 2012-07-24 |
| 60429-188-30 | EA - Each | 60429-188 | 6d31940b-c0c0-4961-bed5-4ffcecb4a176 | 1 | 2012-07-24 |
| 60429-188-60 | EA - Each | 60429-188 | 3613349d-24fc-42ce-b88b-a9b23b02a818 | 1 | 2012-07-24 |
| 60429-188-90 | EA - Each | 60429-188 | c2d18039-32d8-48d4-ad21-60e9030db6db | 1 | 2012-07-24 |