Trazodone Hydrochloride

Product NDC: 71335-0035
Requested package NDC: 71335-0035-4
11-digit product format: 713350035
Labeler code: 71335
Product ID: 71335-0035_b3160ac4-5942-4f03-ab86-7eae70581b71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071258
Marketing category: ANDA
Marketing start: 2008-11-17
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0035	71335-0035-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A071258-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1987-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071258-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071258-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071258-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071258-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071258-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071258-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071258-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071258-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071258-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071258-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071258-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071258-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071258-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071258-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071258-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071258-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071258-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071258-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071258-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071258-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071258-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071258-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071258-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071258-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071258-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071258-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071258-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071258-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071258-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071258-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071258-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071258-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071258-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071258-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071258-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071258-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071258-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071258-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071258-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071258-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071258-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0035-1	EA - Each	71335-0035	def53e01-3863-4247-b890-a94ac3186e97	1	2018-03-08
71335-0035-2	EA - Each	71335-0035	9f8acde5-79ba-4372-a9d2-01900c3a0894	1	2018-03-08
71335-0035-3	EA - Each	71335-0035	7b41832d-636f-4c1a-a700-9ab448fe7842	1	2018-03-08
71335-0035-4	EA - Each	71335-0035	b6f562b5-1b64-477d-8e5b-dabadcd037da	1	2018-03-08
71335-0035-5	EA - Each	71335-0035	359acac2-9000-43a2-ba68-e96556051e23	1	2018-03-08
71335-0035-6	EA - Each	71335-0035	4442768c-08e2-4d51-a7c7-c56c195c3847	1	2018-03-08
71335-0035-7	EA - Each	71335-0035	c1e1bbd9-c5d1-4253-a5ca-d6be9a75203c	1	2018-03-08
71335-0035-8	EA - Each	71335-0035	e5f8ea25-9b55-4e46-8962-4f9c898cda72	1	2018-03-08
71335-0035-9	EA - Each	71335-0035	8c85d420-efb6-45f4-b787-f577d4181e42	1	2018-03-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Apotex Corp	71961ab1-951d-1493-f76c-2ff25cca2a85	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071258 application number: ANDA071258
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): 071258 application number: ANDA071258

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	Marketing end	Sample	Exclude flag	Status
71335-0035-4	71335003504	90 TABLET in 1 BOTTLE (71335-0035-4)	90 tablet	2021-12-27	0000-00-00	No	No	Current