Trazodone Hydrochloride

Product NDC: 70518-2973
11-digit product format: 705182973
Labeler code: 70518
Product ID: 70518-2973_57e9b9cb-9978-b908-e063-6394a90ad848
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA071524
Marketing category: ANDA
Marketing start: 2021-01-12
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2973	70518-2973-1	D	Discontinued by firm		2026-10-05
excluded package	package	70518-2973	70518-2973-3	D	Discontinued by firm		2026-10-05

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 · 11 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071524-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071524-001	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 · 43 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	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A071524-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	AB	1	`f41ea6bd6efb…`

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

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
856373	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
7bba99e5-4096-4fcb-8591-dc4a9bfe975e	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	SPL version
70518-2973-0	Trazodone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	13
70518-2973-1	Trazodone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	13
70518-2973-2	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	13
70518-2973-3	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2973	TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 4 package rows	20250429_7bba99e5-4096-4fcb-8591-dc4a9bfe975e.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524 ndc (product): 70518-2973
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	df17cec9-ad5e-4e57-8572-c927c9b955e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	b3723265-7455-c25c-e053-2a95a90a379b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b617348c-cb19-45df-b313-4ea6af6f1dda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Northwind Health Company, LLC	e07d7ee3-776d-1fa3-e053-2a95a90a7019	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5ab590d8-225f-43f4-bb68-1f2c86f9a886	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4006d439-e2de-4590-82e9-fc9d56e3ec1b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	203881a3-37d0-41dd-86c5-1e53fb784326	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524

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
856373	traZODone HCl 100 MG Oral Tablet	PSN	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	13
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2973-0	70518297300	30 TABLET in 1 BLISTER PACK (70518-2973-0)	30 tablet	2021-01-12	0000-00-00	No	No	Current
70518-2973-1	70518297301	30 TABLET in 1 BLISTER PACK (70518-2973-1)	30 tablet	2021-01-29	0000-00-00	No	No	Current
70518-2973-2	70518297302	90 TABLET in 1 BOTTLE, PLASTIC (70518-2973-2)	90 tablet	2021-06-09	0000-00-00	No	No	Current
70518-2973-3	70518297303	90 in 1 BOTTLE, PLASTIC						Historical