Trazodone Hydrochloride

Product NDC: 63187-133
11-digit product format: 631870133
Labeler code: 63187
Product ID: 63187-133_739358e1-cc8b-4b5c-be06-4eeb8183cf8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA071524
Marketing category: ANDA
Marketing start: 1990-09-30
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-133		D	Discontinued by firm	2026-08-17
excluded package	package	63187-133	63187-133-30	D	Discontinued by firm	2026-08-17
excluded package	package	63187-133	63187-133-60	D	Discontinued by firm	2026-08-17
excluded package	package	63187-133	63187-133-90	D	Discontinued by firm	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 · 8 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	63187-133-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-133-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-133-30	`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	63187-133-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-133-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-133-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`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	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…`
2022-09-29 23:25 UTC	2022-09	A071524-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-133-30	EA - Each	63187-133	8e7a2ea1-f6a4-4163-9d1c-43127fff32b4	1	2015-06-09
63187-133-90	EA - Each	63187-133	dbb4dac1-3aa0-4a56-b163-5d2f5a81ef24	1	2023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-133	TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	8	Legacy NDC	20200128_8ab02532-35f7-4f99-941b-bc49eff1e8ae.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-133-30	63187013330	30 TABLET in 1 BOTTLE (63187-133-30)	30 tablet	2014-06-02	0000-00-00	No	No	Current
63187-133-60	63187013360	60 TABLET in 1 BOTTLE (63187-133-60)	60 tablet	2014-06-02	0000-00-00	No	No	Current
63187-133-90	63187013390	90 TABLET in 1 BOTTLE (63187-133-90)	90 tablet	2017-06-01	0000-00-00	No	No	Current