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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-731063629-7310-2DDiscontinued by firm2026-08-03

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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-731063629-7310-2DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076037-001NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16
A076037-002NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16
A076037-003NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16
A076037-004NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16
A076037-005NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16

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.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-165bbf6a4d5a75…

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nefazodone HydrochlorideNEFAZODONE HYDROCHLORIDEBryant Ranch Prepack0bd4c34a-4f43-4c84-8b98-1d074cba97d52025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076037
application number: ANDA076037
Nefazodone HydrochlorideNEFAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.51ff7db5-aaf9-4c3c-86e6-958ebf16b60f2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076037
application number: ANDA076037

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7310-26362973100228 TABLET in 1 BOTTLE (63629-7310-2) 28 tablet2017-06-130000-00-00NoNoCurrent