Nefazodone Hydrochloride

Product NDC: 68788-7246
Requested package NDC: 68788-7246-6
11-digit product format: 687887246
Labeler code: 68788
Product ID: 68788-7246_5db7a326-323c-4519-b040-a8fdbe106685
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nefazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA076037
Marketing category: ANDA
Marketing start: 2018-08-20
Marketing end: 0000-00-00
Substance: NEFAZODONE HYDROCHLORIDE
Active strength: 150 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7246	68788-7246-6	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A076037-001	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16
A076037-002	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16
A076037-003	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16
A076037-004	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16
A076037-005	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16

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.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL		2003-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076037-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	RS	2003-09-16	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7246-1	EA - Each	68788-7246	5b0928d6-f5ed-4530-a10d-f84005c4e61e	1	2018-11-06
68788-7246-3	EA - Each	68788-7246	f7297fff-f598-4867-84c2-14199b2d6ce5	1	2018-11-06
68788-7246-6	EA - Each	68788-7246	cb5e8680-c611-4eac-9fa8-b8ebc3405f62	1	2018-11-06
68788-7246-8	EA - Each	68788-7246	a3cb12b9-25ce-4468-a9cf-47c7a01b5447	1	2018-11-06
68788-7246-9	EA - Each	68788-7246	89ef5789-908f-402f-959b-96c25cd71a3b	1	2018-11-06

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	0bd4c34a-4f43-4c84-8b98-1d074cba97d5	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076037 application number: ANDA076037
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	51ff7db5-aaf9-4c3c-86e6-958ebf16b60f	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076037 application number: ANDA076037

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27X63J94GR	NEFAZODONE HYDROCHLORIDE	82752-99-6	NEFAZODONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7246-6	68788724606	60 TABLET in 1 BOTTLE (68788-7246-6)	60 tablet	2018-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nefazodone Hydrochloride	Preferred Pharmaceuticals Inc.	2020-07-30	HUMAN PRESCRIPTION DRUG LABEL	3