FDA.reportPublic FDA data

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

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
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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7046-12025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone 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

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