Trazodone Hydrochloride

Product NDC: 51655-366
11-digit product format: 516550366
Labeler code: 51655
Product ID: 51655-366_49daf198-ebf2-ddd1-e063-6394a90a54d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA071523
Marketing category: ANDA
Marketing start: 2022-11-30
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A071523-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071523-001	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	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`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	A071523-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071523-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071523-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071523-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071523-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071523-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071523-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071523-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071523-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071523-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071523-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071523-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071523-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071523-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071523-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071523-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071523-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071523-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071523-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071523-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071523-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071523-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071523-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071523-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071523-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071523-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071523-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071523-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071523-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071523-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071523-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071523-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071523-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071523-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071523-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071523-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071523-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071523-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071523-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071523-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trazodone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f2f2290f-b53c-3b38-e053-2995a90a157d	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-366-26	2026-01-29	C162847	48780-1	49896155-a023-586f-e063-e6dba90add90	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
51655-366-52	2026-01-29	C162847	48780-1	49896155-a023-586f-e063-e6dba90add90	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-366-26	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90		3
51655-366-52	Trazodone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-366	TRAZODONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 2 package rows	20230306_f2f2290f-b53c-3b38-e053-2995a90a157d.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fdfb9-c060-63bc-e063-6294a90ad840	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	38e9820a-6edc-4bf5-b5e4-034b9e48b583	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523
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): 071523 application number: ANDA071523
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	b3723265-7455-c25c-e053-2a95a90a379b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Northwind Health Company, LLC	f2f2290f-b53c-3b38-e053-2995a90a157d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523 ndc (product): 51655-366
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5ab590d8-225f-43f4-bb68-1f2c86f9a886	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523
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): 071523 application number: ANDA071523
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	f6c3fb84-5b68-4675-a853-fe49bfbf3f9f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071523 application number: ANDA071523

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
856377	traZODone HCl 50 MG Oral Tablet	PSN	f2f2290f-b53c-3b38-e053-2995a90a157d	3
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	f2f2290f-b53c-3b38-e053-2995a90a157d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-366-26	51655036626	90 TABLET in 1 BOTTLE, PLASTIC (51655-366-26)	90 tablet	2023-01-05	No	No	Current
51655-366-52	51655036652	30 TABLET in 1 BOTTLE, PLASTIC (51655-366-52)	30 tablet	2022-11-30	No	No	Current