FDA.reportPublic FDA data

Nefazodone Hydrochloride

Product NDC
21695-177
11-digit product format
216950177
Labeler code
21695
Product ID
21695-177_4afee435-ae60-4260-a1df-e52abf7a043d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nefazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076037
Marketing category
ANDA
Marketing start
2003-09-16
Marketing end
0000-00-00
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-177IInactivated by FDA2026-08-03
excluded packagepackage21695-17721695-177-30IInactivated by FDA2026-08-03
excluded packagepackage21695-17721695-177-60IInactivated by FDA2026-08-03

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

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
21695-177-302019-09-24C16284748780-1934fe258-4ab2-48b1-e053-8cdaa90a720aNEFAZODONE HYDROCHLORIDE TABLETS 7178 1024 7113 1025 1026 (Patient Information Included)
21695-177-602019-09-24C16284748780-1934fe258-4ab2-48b1-e053-8cdaa90a720aNEFAZODONE HYDROCHLORIDE TABLETS 7178 1024 7113 1025 1026 (Patient Information Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-177-30Nefazodone Hydrochloride30 in 1 BOTTLETABLET301
21695-177-60Nefazodone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-177-30EA - Each21695-177799a3c50-db62-4ba0-a705-9beafd30c89612012-07-24
21695-177-60EA - Each21695-177607e63e9-8f25-4c6f-9511-93d9e79ab39d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-177NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110622_4afee435-ae60-4260-a1df-e52abf7a043d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-177-302169501773030 in 1 BOTTLEHistorical
21695-177-602169501776060 in 1 BOTTLEHistorical