Nefazodone Hydrochloride
- Product NDC
- 68788-7217
- 11-digit product format
- 687887217
- Labeler code
- 68788
- Product ID
- 68788-7217_ae44bbbf-7b55-4a4d-a3a7-c7f88b68f690
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nefazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA076037
- Marketing category
- ANDA
- Marketing start
- 2018-07-26
- Marketing end
- 0000-00-00
- Substance
- NEFAZODONE HYDROCHLORIDE
- Active strength
- 200 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 | 68788-7217 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-7217 | 68788-7217-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-7217 | 68788-7217-6 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-7217 | 68788-7217-9 | 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 |
|---|---|---|---|---|---|---|---|
| A076037-001 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-002 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-003 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-004 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-005 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Nefazodone Hydrochloride | NEFAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 0bd4c34a-4f43-4c84-8b98-1d074cba97d5 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 076037 ANDA076037 |
| Nefazodone Hydrochloride | NEFAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 076037 ANDA076037 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7217-3 | 68788721703 | 30 TABLET in 1 BOTTLE (68788-7217-3) | 30 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |
| 68788-7217-6 | 68788721706 | 60 TABLET in 1 BOTTLE (68788-7217-6) | 60 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |
| 68788-7217-9 | 68788721709 | 90 TABLET in 1 BOTTLE (68788-7217-9) | 90 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |