Trazodone Hydrochloride

Product NDC: 0555-0711
Requested package NDC: 0555-0711-02
11-digit product format: 005550711
Labeler code: 0555
Product ID: 0555-0711_3902eb87-aa22-4775-b56a-7cb86c5f920e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071196
Marketing category: ANDA
Marketing start: 2021-12-09
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 300 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071196-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25
A071196-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26
A071196-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A071196-001	AB
A071196-002	AB
A071196-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A071196-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071196-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071196-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071196-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071196-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071196-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071196-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071196-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071196-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071196-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071196-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071196-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071196-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071196-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071196-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071196-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071196-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071196-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071196-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071196-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071196-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071196-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071196-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-001	AB	1	`301d65b070ca…`

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	300 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
856369	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
9c4da6ad-d4d1-4e8c-918d-8ac48512a93f	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	Strength	SPL version
0555-0711-02	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0711-02	EA - Each	0555-0711	607f2df7-5661-4439-810b-734635a29611	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0711	TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20221029_9c4da6ad-d4d1-4e8c-918d-8ac48512a93f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	dc1f347e-1acb-4c06-b36e-f15fecb7ac93	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Apotex Corp	71961ab1-951d-1493-f76c-2ff25cca2a85	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5d22a06c-9cb8-4b49-8d67-769d181ad70c	2021-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	9c4da6ad-d4d1-4e8c-918d-8ac48512a93f	2020-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196 ndc (package): 0555-0711-02 ndc (product): 0555-0711 ndc11 (package): 00555071102

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
856369	traZODone HCl 300 MG Oral Tablet	PSN	9c4da6ad-d4d1-4e8c-918d-8ac48512a93f	3
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	9c4da6ad-d4d1-4e8c-918d-8ac48512a93f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0711-02	00555071102	100 TABLET in 1 BOTTLE (0555-0711-02)	100 tablet	2021-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	2020-06-30	HUMAN PRESCRIPTION DRUG LABEL	3