Trazodone Hydrochloride

Product NDC: 68071-5187
11-digit product format: 680715187
Labeler code: 68071
Product ID: 68071-5187_d775143a-5ca1-9d10-e053-2995a90a7eb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA206923
Marketing category: ANDA
Marketing start: 2018-10-05
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-5187		D	Discontinued by firm		2026-08-17
excluded package	package	68071-5187	68071-5187-9	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-5187-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-5187-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-5187-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-5187-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-5187-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-5187-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-5187-9	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-5187-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-5187-9	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-5187-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-5187-9	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-5187-9	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206923-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08
A206923-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08
A206923-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08
A206923-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206923-001	AB
A206923-002	AB
A206923-003	AB
A206923-004	AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206923-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206923-004	AB	1	`d8e5a09893c0…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5187-9	2022-02-07	C162847	48780-1	d6a99b39-6d82-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
68071-5187-9	2022-01-28	C162847	48780-1	d6a99b39-6d82-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	5605e909-dc75-4578-94c6-41bb96ba3e2a	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	78c3188c-d42f-4d3d-aa42-3c146dfe08ee	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Accord Healthcare, Inc.	ed3039d8-3d27-4b71-a4b0-812943c9457f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	a90caa68-b28e-425f-b77c-7b566ac17dc2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE	25332-39-2	TRAZODONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5187-9	68071518709	90 TABLET in 1 BOTTLE (68071-5187-9)	90 tablet	2020-02-27	0000-00-00	No	No	Current