Trazodone Hydrochloride

Product NDC: 43353-653
11-digit product format: 433530653
Labeler code: 43353
Product ID: 43353-653_79266f41-f728-4daa-9c57-b2a5f3881e17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA072193
Marketing category: ANDA
Marketing start: 2010-05-30
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: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-653		I	Inactivated by FDA	2026-10-05
excluded package	package	43353-653	43353-653-30	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-653	43353-653-53	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-653	43353-653-60	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-653	43353-653-80	I	Inactivated by FDA	2026-10-05

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 2 of 2 · 105 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
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	43353-653-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-653-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-653-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-653-53	`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	43353-653-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-653-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-653-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-653-53	`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	43353-653-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-653-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-653-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-653-53	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-653-80	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-653-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-653-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-653-53	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-653-80	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-653-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-653-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-653-53	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-653-80	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-653-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-653-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-653-53	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-653-80	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-653-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-653-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-653-53	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-653-80	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-653-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-653-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-653-53	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-653-80	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-653-60	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-653-30	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-653-53	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A072193-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02
A072193-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	25MG	TABLET / ORAL		RS	2026-09-01
A072193-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	75MG	TABLET / ORAL		RS	2026-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072193-001	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 · 45 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
2026-09-14 22:38:34	2026-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072193-002	TRAZODONE HYDROCHLORIDE	25MG	TABLET / ORAL		RS	2026-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072193-003	TRAZODONE HYDROCHLORIDE	75MG	TABLET / ORAL		RS	2026-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02	`3bdfa0b2c4d7…`

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	A072193-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
43353-653-30	These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP . Trazodone Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1981
43353-653-53	These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP . Trazodone Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1981
43353-653-60	These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP . Trazodone Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1981
43353-653-80	These highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP . Trazodone Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-653-30	Trazodone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	1
43353-653-53	Trazodone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	1
43353-653-60	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	1
43353-653-80	Trazodone Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-653-30	EA - Each	43353-653	8ec5050f-21b4-4b16-811b-b7fea6cb8178	1	2014-06-03
43353-653-53	EA - Each	43353-653	5baaa236-e4f0-4f38-aa55-f522dabddc88	1	2014-06-03
43353-653-60	EA - Each	43353-653	836abc32-50e1-4a50-8f20-8478b702765b	1	2014-06-03
43353-653-80	EA - Each	43353-653	66d47db9-3ac9-4f7f-99c6-efe9670808ec	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-653	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 4 package rows	20140513_26d30297-fda9-45a4-b94a-a9f401705818.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	TRUPHARMA LLC	a57da4f8-151d-4a74-8710-6158d1da3852	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072193 application number: ANDA072193
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): 072193 application number: ANDA072193

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
856373	traZODone HCl 100 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-653-30	43353065330	30 in 1 BOTTLE, PLASTIC	Historical
43353-653-53	43353065353	60 in 1 BOTTLE, PLASTIC	Historical
43353-653-60	43353065360	90 in 1 BOTTLE, PLASTIC	Historical
43353-653-80	43353065380	180 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2014-05-13	HUMAN PRESCRIPTION DRUG LABEL	1