TRAZODONE HYDROCHLORIDE

Product NDC: 61919-386
11-digit product format: 619190386
Labeler code: 61919
Product ID: 61919-386_875b4218-beb7-c7c2-e053-2995a90a897b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAZODONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA072192
Marketing category: ANDA
Marketing start: 2019-04-25
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#

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 product	product	61919-386		I	Inactivated by FDA		2026-08-17
excluded package	package	61919-386	61919-386-90	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-386-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-386-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-386-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-386-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-386-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-386-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-386-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-386-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-386-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-386-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-386-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-386-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-386-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-386-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-386-90	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1989-02-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072192-001	AB	1	`caaa826d4ba7…`
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…`

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
61919-386-90	2025-01-31	C162847	48780-1	1030e365-3aa2-111a-e063-dadaa90a10e2	TRAZODONE HYDROCHLORIDE
61919-386-90	2024-01-30	C162847	48780-1	1030e365-3aa2-111a-e063-dadaa90a10e2	TRAZODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-386-90	TRAZODONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-386	TRAZODONE HYDROCHLORIDE TABLET TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	3	Legacy NDC, 1 package rows	20190425_66da652a-72b4-c17f-e053-2a91aa0a8d69.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 · 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

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	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	traZODone HCl 50 MG Oral Tablet	PSN	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-386-90	61919038690	90 TABLET, FILM COATED in 1 BOTTLE (61919-386-90)	2019-04-25	0000-00-00	No	No	Current