Trazodone Hydrochloride

Product NDC: 50111-450
11-digit product format: 501110450
Labeler code: 50111
Product ID: 50111-450_3313a8d0-eb39-47a4-b476-0973aad30e02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071525
Marketing category: ANDA
Marketing start: 2020-03-11
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	50111-450		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	50111-450	50111-450-88	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
excluded product	product	50111-450		D	Discontinued by firm	2026-08-17
excluded package	package	50111-450	50111-450-01	D	Discontinued by firm	2026-08-17
excluded package	package	50111-450	50111-450-02	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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	50111-450-88	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	50111-450-88	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50111-450-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50111-450-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071525-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1988-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071525-001	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 2 · 42 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	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A071525-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071525-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071525-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071525-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071525-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071525-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071525-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071525-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071525-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071525-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071525-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071525-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071525-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071525-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071525-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071525-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071525-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071525-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071525-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071525-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071525-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071525-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071525-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071525-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071525-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071525-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071525-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071525-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071525-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071525-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071525-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071525-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071525-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071525-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071525-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071525-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071525-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071525-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071525-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071525-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trazodone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6E8ZO8LRNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856364	Internal RxNorm lookup
856373	Internal RxNorm lookup
856377	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4006d439-e2de-4590-82e9-fc9d56e3ec1b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525e	Product name	1	20250730
b2f15d64-48ea-ba98-af5c-91f410667b31	Product name	5	20250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50111-450-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100		30
50111-450-02	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-450-01	EA - Each	50111-450	887cd145-c278-4b6e-958c-44345f23e190	1	2020-04-20
50111-450-02	EA - Each	50111-450	32959d4c-cb4b-4532-b0c2-a67db5085a75	1	2020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50111-450	TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]	28	Current NDC, Legacy NDC, 2 package rows	20230210_4006d439-e2de-4590-82e9-fc9d56e3ec1b.zip

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	NCS HealthCare of KY, LLC dba Vangard Labs	310c4b81-d2cf-4014-873d-e71d036105de	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	a382ac4d-9ab9-796a-e053-2a95a90a2c26	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9b022ae9-dd52-43ae-804b-ddf8e7cfd530	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4006d439-e2de-4590-82e9-fc9d56e3ec1b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525 ndc (product): 50111-450

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856373	traZODone HCl 100 MG Oral Tablet	PSN	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856364	traZODone HCl 150 MG Oral Tablet	PSN	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856377	traZODone HCl 50 MG Oral Tablet	PSN	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	4006d439-e2de-4590-82e9-fc9d56e3ec1b	30
856364	traZODone HCl 150 MG Oral Tablet	PSN	9b022ae9-dd52-43ae-804b-ddf8e7cfd530	24
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	9b022ae9-dd52-43ae-804b-ddf8e7cfd530	24
856364	traZODone HCl 150 MG Oral Tablet	PSN	310c4b81-d2cf-4014-873d-e71d036105de	12
856377	traZODone HCl 50 MG Oral Tablet	PSN	310c4b81-d2cf-4014-873d-e71d036105de	12
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	310c4b81-d2cf-4014-873d-e71d036105de	12
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	310c4b81-d2cf-4014-873d-e71d036105de	12
856364	traZODone HCl 150 MG Oral Tablet	PSN	a382ac4d-9ab9-796a-e053-2a95a90a2c26	4
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	a382ac4d-9ab9-796a-e053-2a95a90a2c26	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50111-450-01	50111045001	100 TABLET in 1 BOTTLE (50111-450-01)	100 tablet	2020-03-11	0000-00-00	No	No	Current
50111-450-02	50111045002	500 TABLET in 1 BOTTLE (50111-450-02)	500 tablet	2020-03-11	0000-00-00	No	No	Current
50111-450-88	50111045088	23500 TABLET in 1 CONTAINER (50111-450-88)	23500 tablet	20-JUN-25				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	12
Trazodone Hydrochloride	AvKARE	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	4
Trazodone Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	24
Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	30
Trazodone Hydrochloride	REMEDYREPACK INC.	2024-03-06	HUMAN PRESCRIPTION DRUG LABEL	6