Application 206923

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

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…`

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 ndc (product): 71335-1483
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 ndc (product): 71335-1575
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 ndc (product): 16729-301 ndc (product): 16729-299 ndc (product): 16729-302 ndc (product): 16729-300
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 ndc (product): 71205-630

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-299	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-299	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-300	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-300	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-301	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-301	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-302	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
16729-302	Trazodone Hydrochloride	Trazodone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
50090-6121	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
55700-739	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-739	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-739	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-782	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-782	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-844	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-844	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-844	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
67296-1411	Trazodone Hydrochloride	Trazodone Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-5187	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5187	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3082	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-370	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-370	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-370	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-620	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-630	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71205-630	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1483	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1483	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1575	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1575	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current