FDA.reportPublic FDA data

Nefazodone Hydrochloride

Product NDC
0093-7113
11-digit product format
000937113
Labeler code
0093
Product ID
0093-7113_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
150 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 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16a50c72e98297…

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
ndc (product): 0093-7113

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 · 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
0093-7113-06Nefazodone Hydrochloride60 in 1 BOTTLETABLET6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7113-06EA - Each0093-711334604145-aa16-43de-b6e6-84e2241ae31312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEFAZODONE HYDROCHLORIDEACTIVE INGREDIENT27X63J94GRNEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
NEFAZODONEACTIVE MOIETY59H4FCV1TFNEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]4
nefazodone hydrochlorideACTIVE INGREDIENT27X63J94GRNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
nefazodoneACTIVE MOIETY59H4FCV1TFNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7113NEFAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20220716_51ff7db5-aaf9-4c3c-86e6-958ebf16b60f.zip

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
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
1098649nefazodone HCl 100 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098666nefazodone HCl 150 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098670nefazodone HCl 200 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098674nefazodone HCl 250 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098649nefazodone hydrochloride 100 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098666nefazodone hydrochloride 150 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098670nefazodone hydrochloride 200 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098674nefazodone hydrochloride 250 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7113-060009371130660 TABLET in 1 BOTTLE (0093-7113-06) 60 tablet2003-09-160000-00-00NoNoCurrent