Trazodone Hydrochloride
- Product NDC
- 70518-1287
- 11-digit product format
- 705181287
- Labeler code
- 70518
- Product ID
- 70518-1287_7f9aee8d-37fa-2e61-e053-2991aa0a9e8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA073137
- Marketing category
- ANDA
- Marketing start
- 2018-07-09
- 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 product | product | 70518-1287 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70518-1287 | 70518-1287-0 | 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 |
|---|---|---|---|---|---|---|---|
| A073137-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1993-03-24 | |
| A073137-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1993-03-24 | |
| A073137-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1995-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073137-001 | AB |
| A073137-002 | AB |
| A073137-003 | 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 | A073137-001 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1993-03-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A073137-002 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1993-03-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A073137-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 1995-12-22 | 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 | A073137-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A073137-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A073137-003 | 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 | Coupler LLC | 55f18806-6c23-783b-e063-6294a90acc46 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 073137 ANDA073137 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Coupler LLC | 4c4ca53e-9201-298c-e063-6294a90a72c6 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 073137 ANDA073137 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | fa7afa93-b98c-4dc7-bbb8-ab6a058427b9 | 2025-07-11 | Boxed warning, Warnings, Adverse reactions | 073137 ANDA073137 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | f291b905-a739-5e43-e053-2995a90ac40c | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | 073137 ANDA073137 |