FDA.reportPublic FDA data

NDC 63304-545 - Nefazodone hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63304-545
Package NDCs from labels
63304-545-30, 63304-545-05
Manufacturer
Ranbaxy Pharmaceuticals Inc.
Effective date
2008-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nefazodone hydrochloride - Ranbaxy Pharmaceuticals Inc.Ranbaxy Pharmaceuticals Inc.2008-12-24HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-545-05Nefazodone hydrochloride500 in 1 BOTTLETABLET5001
63304-545-30Nefazodone hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-545NEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]12 package rows20090313_b1d149db-ad43-4f3f-aef1-fb0395ba4191.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nefazodone hydrochlorideACTIVE INGREDIENT27X63J94GRNEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
nefazodoneACTIVE MOIETY59H4FCV1TFNEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
ferric oxide (red and/or yellow)INACTIVE INGREDIENTNEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UNEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94ENEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1
sodium starch glycolateINACTIVE INGREDIENTNEFAZODONE HYDROCHLORIDE TABLET [RANBAXY PHARMACEUTICALS INC.]1

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 ยท 3 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
rxcui: 1098666
Nefazodone HydrochlorideNEFAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.51ff7db5-aaf9-4c3c-86e6-958ebf16b60f2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1098649
rxcui: 1098666
rxcui: 1098670
rxcui: 1098674
rxcui: 1098678
5108CA5E-2AFE-5561-02A5-AF90B911698Ab1d149db-ad43-4f3f-aef1-fb0395ba41912008-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 5108CA5E-2AFE-5561-02A5-AF90B911698A
spl set id: b1d149db-ad43-4f3f-aef1-fb0395ba4191

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.