Nefazodone Hydrochloride
- Product NDC
- 63629-7310
- Requested package NDC
- 63629-7310-2
- 11-digit product format
- 636297310
- Labeler code
- 63629
- Product ID
- 63629-7310_498ea1ce-c77a-4a4d-9d1f-ea7bd58a92a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nefazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076037
- Marketing category
- ANDA
- Marketing start
- 2003-09-16
- 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#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-7310 | 63629-7310-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | b8a1b40f171c… | |
| 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… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-7310-2 | 63629731002 | 28 TABLET in 1 BOTTLE (63629-7310-2) | 28 tablet | 2017-06-13 | 0000-00-00 | No | No | Current |