Trazodone Hydrochloride

Product NDC: 71610-537
Requested package NDC: 71610-537-30
11-digit product format: 716100537
Labeler code: 71610
Product ID: 71610-537_3eee48e1-08c4-2e12-e063-6394a90a2b13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA071524
Marketing category: ANDA
Marketing start: 2020-10-08
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071524-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	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
A071524-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071524-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	100 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	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	SPL version
71610-537-30	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	4
71610-537-45	Trazodone Hydrochloride	45 in 1 BOTTLE	TABLET	45	4
71610-537-53	Trazodone Hydrochloride	60 in 1 BOTTLE	TABLET	60	4
71610-537-60	Trazodone Hydrochloride	90 in 1 BOTTLE	TABLET	90	4
71610-537-80	Trazodone Hydrochloride	180 in 1 BOTTLE	TABLET	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-537-30	EA - Each	71610-537	02b09201-6a7f-419c-b4d9-38132e19d963	1	2021-05-05
71610-537-45	EA - Each	71610-537	c9638617-9edf-467e-bc99-fc505ca5b95a	1	2025-11-13
71610-537-53	EA - Each	71610-537	c8fa7f7b-1dd3-4bcf-b2ae-cf207ee14f77	1	2021-05-05
71610-537-60	EA - Each	71610-537	422aefc4-2e94-4d4e-9e79-fbcdb29f650f	1	2021-05-05
71610-537-80	EA - Each	71610-537	f842178f-f108-4d85-86e2-9cfec88f0f97	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-537	TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 5 package rows	20240725_d42fd0c8-3673-4f18-a6c0-cd276bbf9fef.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	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	df17cec9-ad5e-4e57-8572-c927c9b955e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	b3723265-7455-c25c-e053-2a95a90a379b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b617348c-cb19-45df-b313-4ea6af6f1dda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Northwind Health Company, LLC	e07d7ee3-776d-1fa3-e053-2a95a90a7019	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
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): 071524 application number: ANDA071524 ndc (package): 71610-537-30 ndc (product): 71610-537 ndc11 (package): 71610053730
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): 071524 application number: ANDA071524
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): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	203881a3-37d0-41dd-86c5-1e53fb784326	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524

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	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	4
856377	traZODone HCl 50 MG Oral Tablet	PSN	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	4
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	4
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-537-30	71610053730	30 TABLET in 1 BOTTLE (71610-537-30)	30 tablet	2021-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	4