Nefazodone Hydrochloride

Product NDC
0093-7178
11-digit product format
000937178
Labeler code
0093
Product ID
0093-7178_11cdc932-271c-4988-aad9-076340888bce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nefazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076037
Marketing category
ANDA
Marketing start
2003-09-16
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 HYDROCHLORIDE50 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098649Internal RxNorm lookup
1098666Internal RxNorm lookup
1098670Internal RxNorm lookup
1098674Internal RxNorm lookup
1098678Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51ff7db5-aaf9-4c3c-86e6-958ebf16b60fAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7178-01Nefazodone Hydrochloride100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7178-01EA - Each0093-7178c1f82566-fc06-47ae-85b4-ca6e0849332112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7178NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20220716_51ff7db5-aaf9-4c3c-86e6-958ebf16b60f.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
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
ndc (product): 0093-7178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098649nefazodone HCl 100 MG Oral TabletPSN51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098666nefazodone HCl 150 MG Oral TabletPSN51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098670nefazodone HCl 200 MG Oral TabletPSN51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098674nefazodone HCl 250 MG Oral TabletPSN51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098678nefazodone HCl 50 MG Oral TabletPSN51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098649nefazodone hydrochloride 100 MG Oral TabletSCD51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098666nefazodone hydrochloride 150 MG Oral TabletSCD51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098670nefazodone hydrochloride 200 MG Oral TabletSCD51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098674nefazodone hydrochloride 250 MG Oral TabletSCD51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12
1098678nefazodone hydrochloride 50 MG Oral TabletSCD51ff7db5-aaf9-4c3c-86e6-958ebf16b60f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7178-0100093717801100 TABLET in 1 BOTTLE (0093-7178-01) 100 tablet2003-09-160000-00-00NoNoCurrent