Nefazodone Hydrochloride

Product NDC
63629-7214
Requested package NDC
63629-7214-2
11-digit product format
636297214
Labeler code
63629
Product ID
63629-7214_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
250 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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-721463629-7214-2DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-721463629-7214-2DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-721463629-7214-2DDiscontinued 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#

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.

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
63629-7214-26362972140230 TABLET in 1 BOTTLE (63629-7214-2) 30 tablet2017-03-160000-00-00NoNoCurrent