Trazodone Hydrochloride

Product NDC: 50090-2373
Requested package NDC: 50090-2373-3
11-digit product format: 500902373
Labeler code: 50090
Product ID: 50090-2373_c038b3e0-7864-4a56-896f-a5b2d7e6c0ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA071196
Marketing category: ANDA
Marketing start: 2008-11-17
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50090-2373	50090-2373-3	D	Discontinued by firm		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 · 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 3 · 87 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
2024-06-18 03:08 UTC · 2 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 · 2 captures of this ZIP	2024-06	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 2 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…`
2024-05-31 18:47 UTC	2024-05	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A071196-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A071196-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 2 captures of this ZIP	2024-06	A071196-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071196-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071196-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071196-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071196-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071196-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071196-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071196-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071196-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071196-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071196-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071196-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071196-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071196-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071196-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071196-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071196-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071196-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071196-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071196-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071196-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071196-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071196-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071196-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071196-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071196-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071196-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071196-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071196-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071196-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071196-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071196-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071196-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071196-001	AB	1	`b00525d2431f…`

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 · 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2373-0	2020-02-17	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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
50090-2373-2	2020-02-17	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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
50090-2373-3	2020-02-17	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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
50090-2373-0	2020-01-31	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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
50090-2373-2	2020-01-31	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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
50090-2373-3	2020-01-31	C162847	48780-1	9d75b9d0-e608-f424-e053-dadaa90a57ce	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2373-0	EA - Each	50090-2373	33ed1b03-c05a-4a74-92d7-2aa16aa56c99	1	2019-02-13
50090-2373-2	EA - Each	50090-2373	6674a8a0-d16a-4d24-8b39-f30ba292ac97	1	2018-11-06
50090-2373-3	EA - Each	50090-2373	97173bf0-3a69-4037-bb8e-d32c8f2741b6	1	2018-11-06

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
50090-2373-3	50090237303	90 TABLET in 1 BOTTLE (50090-2373-3)	90 tablet	2016-04-26	0000-00-00	No	No	Current