Trazodone Hydrochloride

Product NDC: 45865-431
Requested package NDC: 45865-431-90
11-digit product format: 458650431
Labeler code: 45865
Product ID: 45865-431_9ab233e3-aa99-452a-e053-2995a90abc2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA072192
Marketing category: ANDA
Marketing start: 2010-05-30
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	45865-431	45865-431-90	I	Inactivated by FDA		2026-08-03

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
A072192-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1989-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072192-001	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	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`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	A072192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072192-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072192-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072192 application number: ANDA072192

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
45865-431-30	2025-01-30	C162847	48780-1	2cef2736-9be8-d83d-e063-dadaa90ab31f	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
45865-431-60	2025-01-30	C162847	48780-1	2cef2736-9be8-d83d-e063-dadaa90ab31f	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
45865-431-90	2025-01-30	C162847	48780-1	2cef2736-9be8-d83d-e063-dadaa90ab31f	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	SPL version
45865-431-30	Trazodone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
45865-431-60	Trazodone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2
45865-431-90	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-431	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 3 package rows	20191228_7202fa6e-86ed-813b-e053-2a95a90a7055.zip

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
856377	traZODone HCl 50 MG Oral Tablet	PSN	7202fa6e-86ed-813b-e053-2a95a90a7055	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	7202fa6e-86ed-813b-e053-2a95a90a7055	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-431-90	45865043190	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-431-90)	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Medsource Pharmaceuticals \| Medsource Pharamceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2