Trazodone Hydrochloride

Product NDC: 50090-8077
11-digit product format: 500908077
Labeler code: 50090
Product ID: 50090-8077_acec06a6-2763-476f-b753-32bddf4c8e26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA205253
Marketing category: ANDA
Marketing start: 2026-01-22
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 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 43.

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
A205253-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10
A205253-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10
A205253-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10
A205253-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205253-001	AB
A205253-002	AB
A205253-003	AB
A205253-004	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 · 172 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	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A205253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205253-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-004	AB	1	`5bbf6a4d5a75…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	100 mg/1

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9962589c-ee1f-4d5e-bd49-b7807bb60ace	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Major Pharmaceuticals	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Cardinal Health 107, LLC	9265f4f6-df24-4495-9dbf-e3fcfa4c864d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	42ecd35c-4300-4cd3-942a-f3efb872fa99	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	65ef34fb-8fe4-4e9d-9068-98702515ffeb	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2d3f1d0b-3686-f4d7-e063-6394a90a1a76	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
TRAZODONE HCL	TRAZODONE HCL	Advanced Rx Pharmacy of Tennessee, LLC	d27e4473-6f62-ddfe-e053-2a95a90a9a2c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	9df17765-5d41-4e26-98de-850658114534	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	85bb3f78-5cf2-1319-e053-2991aa0ade75	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6adb446d-cd2f-3d6b-e053-2991aa0a2114	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	88ac1a9d-8483-4b29-9fe6-2e60e51f3005	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Medsource Pharmaceuticals	12f1737b-c021-d0f2-e063-6294a90a6f29	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Asclemed USA, Inc.	04a676ee-358e-484d-9de4-a9a88d908ba8	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	3df90104-ef2c-4a82-b007-9843c43969ae	2023-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	ac678c51-b1d3-4d6b-9599-7ef565b469d2	2023-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8077-0	50090807700	1000 TABLET in 1 BOTTLE (50090-8077-0)	1000 tablet	2026-09-16	No	No	Current