Trazodone Hydrochloride

Product NDC: 50090-0463
Requested package NDC: 50090-0463-2
11-digit product format: 500900463
Labeler code: 50090
Product ID: 50090-0463_ef76c5ec-1385-4a2a-bea2-811998f57ced
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA071525
Marketing category: ANDA
Marketing start: 1990-09-30
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: 2022-12-31
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	50090-0463	50090-0463-2	I	Inactivated by FDA		2026-09-14

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A071525-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1988-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071525-001	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	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071525-001	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-03-09	`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	A071525-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071525-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071525-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071525-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071525-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071525-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071525-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071525-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071525-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071525-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071525-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071525-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071525-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071525-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071525-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071525-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071525-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071525-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071525-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071525-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071525-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071525-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071525-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071525-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071525-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071525-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071525-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071525-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071525-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071525-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071525-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071525-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071525-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071525-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071525-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071525-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071525-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071525-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071525-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071525-001	AB	1	`f41ea6bd6efb…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0463-2	2023-01-30	C162847	48780-1	f386c64a-25c1-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-0463-4	2023-01-30	C162847	48780-1	f386c64a-25c1-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0463-2	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30		7
50090-0463-4	Trazodone Hydrochloride	90 in 1 BOTTLE	TABLET	90		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0463	TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 2 package rows	20210219_29c443fc-8ef6-4778-8d6a-ad14181ef8de.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	NCS HealthCare of KY, LLC dba Vangard Labs	310c4b81-d2cf-4014-873d-e71d036105de	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	a382ac4d-9ab9-796a-e053-2a95a90a2c26	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9b022ae9-dd52-43ae-804b-ddf8e7cfd530	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071525 application number: ANDA071525
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): 071525 application number: ANDA071525

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
856364	traZODone HCl 150 MG Oral Tablet	PSN	29c443fc-8ef6-4778-8d6a-ad14181ef8de	7
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	29c443fc-8ef6-4778-8d6a-ad14181ef8de	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0463-2	50090046302	30 TABLET in 1 BOTTLE (50090-0463-2)	30 tablet	2016-06-29	0000-00-00	No	No	Current