Application 071523

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

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
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 · 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	A071523-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-12-11	`84e616aacf4f…`
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…`

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	A071523-001	AB	1	`84e616aacf4f…`
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…`

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 ndc (product): 70518-2929
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
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 ndc (product): 71610-529
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 ndc (product): 71610-525
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 ndc (product): 71205-568

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67046-740	Trazodone Hydrochloride	Trazodone Hydrochoride	Contract Pharmacy Services-PA	ANDA	Current
67296-1693	Trazodone Hydrochloride	Trazodone Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1693	Trazodone Hydrochloride	Trazodone Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-2822	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4312	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4312	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4312	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-2825	Trazodone Hydrochloride	Trazodone Hydrochloride	Carilion Materials Management	ANDA	Current
68788-9861	Trazodone Hydrochloride	Trazodone Hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9861	Trazodone Hydrochloride	Trazodone Hydrochloride	Preferred Pharmaceuticals	ANDA	Current
70518-0571	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0571	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0571	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0571	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1499	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1499	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1499	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1499	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1499	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2336	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2929	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-119	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-119	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-119	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-119	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-568	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71205-568	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0287	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-295	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-295	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-525	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-525	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-529	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-529	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current