FDA.reportPublic FDA data

Nefazodone Hydrochloride

Product NDC
68788-7242
Requested package NDC
68788-7242-3
11-digit product format
687887242
Labeler code
68788
Product ID
68788-7242_f2cdc01b-3042-48b6-9eea-b9fe30cfcbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nefazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076037
Marketing category
ANDA
Marketing start
2018-08-14
Marketing end
0000-00-00
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-724268788-7242-3DDiscontinued by firm2026-08-03

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7242-36878872420330 TABLET in 1 BOTTLE (68788-7242-3) 30 tablet2018-08-140000-00-00NoNoCurrent