Trazodone Hydrochloride

Product NDC: 71335-0164
Requested package NDC: 71335-0164-2
11-digit product format: 713350164
Labeler code: 71335
Product ID: 71335-0164_ebafe312-212f-45bb-842c-c9712fe06e0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071196
Marketing category: ANDA
Marketing start: 2008-11-17
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71335-0164	71335-0164-2	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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071196-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071196-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071196-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0164-1	EA - Each	71335-0164	51ac0742-4e64-4aae-82b7-5c772beec0bf	1	2018-03-08
71335-0164-2	EA - Each	71335-0164	8430f2fd-1471-4d57-9cda-5e63479ed40b	1	2018-03-08
71335-0164-3	EA - Each	71335-0164	8006e808-2c19-4e33-8264-13ddeb34a7f3	1	2018-03-08
71335-0164-4	EA - Each	71335-0164	8209e5c3-ec83-4b75-8609-89b5d444f0bb	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 · 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	2026-04-08	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

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
71335-0164-2	71335016402	60 TABLET in 1 BOTTLE (71335-0164-2)	60 tablet	2017-03-24	0000-00-00	No	No	Current