Nefazodone Hydrochloride

Product NDC
63629-7046
11-digit product format
636297046
Labeler code
63629
Product ID
63629-7046_8962e4a7-1e27-4a03-ab51-34fc4f9c6847
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
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 2 · 70 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7046-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7046-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7046-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7046-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7046-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7046-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7046-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7046-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7046-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7046-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7046-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7046-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7046-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7046-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7046-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7046-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7046-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7046-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7046-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7046-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7046-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7046-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7046-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7046-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7046-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7046-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7046-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7046-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7046-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7046-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7046-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7046-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7046-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7046-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7046-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7046-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7046-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7046-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7046-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7046-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7046-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7046-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7046-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7046-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7046-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7046-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7046-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7046-28af77b9d5b6f…d9bbb34c5368…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Nefazodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEFAZODONE HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27X63J94GRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bd4c34a-4f43-4c84-8b98-1d074cba97d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
88e577a5-ea68-76d2-a3c4-7157b94bcfa5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7046-12025-09-04Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22025-09-04Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32025-09-04Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42025-09-04Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12024-01-30Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22024-01-30Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32024-01-30Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42024-01-30Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-02-25Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-02-25Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-02-25Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-02-25Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-01-31Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-01-31Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-01-31Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-01-31Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7046-1Nefazodone Hydrochloride30 in 1 BOTTLETABLET3019
63629-7046-2Nefazodone Hydrochloride120 in 1 BOTTLETABLET12019
63629-7046-3Nefazodone Hydrochloride28 in 1 BOTTLETABLET2819
63629-7046-4Nefazodone Hydrochloride60 in 1 BOTTLETABLET6019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7046NEFAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 4 package rows20220217_0bd4c34a-4f43-4c84-8b98-1d074cba97d5.zip

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
ndc (product): 63629-7046
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098666nefazodone HCl 150 MG Oral TabletPSN0bd4c34a-4f43-4c84-8b98-1d074cba97d519
1098666nefazodone hydrochloride 150 MG Oral TabletSCD0bd4c34a-4f43-4c84-8b98-1d074cba97d519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7046-16362970460130 TABLET in 1 BOTTLE (63629-7046-1) 30 tablet2022-02-080000-00-00NoNoCurrent
63629-7046-263629704602120 TABLET in 1 BOTTLE (63629-7046-2) 120 tablet2016-10-180000-00-00NoNoCurrent
63629-7046-36362970460328 TABLET in 1 BOTTLE (63629-7046-3) 28 tablet2022-02-080000-00-00NoNoCurrent
63629-7046-46362970460460 TABLET in 1 BOTTLE (63629-7046-4) 60 tablet2022-02-080000-00-00NoNoCurrent