Trazodone Hydrochloride

Product NDC: 12634-193
11-digit product format: 126340193
Labeler code: 12634
Product ID: 12634-193_467cacc2-6470-342c-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotheca Inc.
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: 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 · 39 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-193		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-09	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-12	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-18	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-40	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-42	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-45	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-50	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-52	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-63	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-67	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-69	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-74	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-82	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-90	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-92	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-93	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-94	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-95	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-96	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-97	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-98	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-193	12634-193-99	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 14 · 819 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	12634-193-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-193-99	`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	12634-193-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-193-40	`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
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, Related label table
NDC	Related label
12634-193-00	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
12634-193-01	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
12634-193-09	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
12634-193-12	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
12634-193-18	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
12634-193-40	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
12634-193-42	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
12634-193-45	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
12634-193-50	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
12634-193-52	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
12634-193-54	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
12634-193-57	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
12634-193-59	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
12634-193-60	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
12634-193-61	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
12634-193-63	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
12634-193-66	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
12634-193-67	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
12634-193-69	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
12634-193-71	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
12634-193-74	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
12634-193-78	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
12634-193-79	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
12634-193-80	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
12634-193-81	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
12634-193-82	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
12634-193-84	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
12634-193-85	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
12634-193-90	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
12634-193-91	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
12634-193-92	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
12634-193-93	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
12634-193-94	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
12634-193-95	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
12634-193-96	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
12634-193-97	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
12634-193-98	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
12634-193-99	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
12634-193-00	Trazodone Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
12634-193-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
12634-193-09	Trazodone Hydrochloride	35 in 1 BOTTLE	TABLET, FILM COATED	35	1
12634-193-12	Trazodone Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120	1
12634-193-18	Trazodone Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	1
12634-193-40	Trazodone Hydrochloride	40 in 1 BOTTLE	TABLET, FILM COATED	40	1
12634-193-42	Trazodone Hydrochloride	42 in 1 BOTTLE	TABLET, FILM COATED	42	1
12634-193-45	Trazodone Hydrochloride	45 in 1 BOTTLE	TABLET, FILM COATED	45	1
12634-193-50	Trazodone Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	1
12634-193-52	Trazodone Hydrochloride	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	1
12634-193-54	Trazodone Hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
12634-193-57	Trazodone Hydrochloride	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	1
12634-193-59	Trazodone Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	1
12634-193-60	Trazodone Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
12634-193-61	Trazodone Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1
12634-193-63	Trazodone Hydrochloride	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	1
12634-193-66	Trazodone Hydrochloride	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	1
12634-193-67	Trazodone Hydrochloride	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	1
12634-193-69	Trazodone Hydrochloride	9 in 1 BLISTER PACK	TABLET, FILM COATED	9	1
12634-193-71	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
12634-193-74	Trazodone Hydrochloride	24 in 1 BOTTLE	TABLET, FILM COATED	24	1
12634-193-78	Trazodone Hydrochloride	28 in 1 BOTTLE	TABLET, FILM COATED	28	1
12634-193-79	Trazodone Hydrochloride	25 in 1 BOTTLE	TABLET, FILM COATED	25	1
12634-193-80	Trazodone Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
12634-193-81	Trazodone Hydrochloride	21 in 1 BOTTLE	TABLET, FILM COATED	21	1
12634-193-82	Trazodone Hydrochloride	12 in 1 BOTTLE	TABLET, FILM COATED	12	1
12634-193-84	Trazodone Hydrochloride	14 in 1 BOTTLE	TABLET, FILM COATED	14	1
12634-193-85	Trazodone Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
12634-193-90	Trazodone Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
12634-193-91	Trazodone Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	1
12634-193-92	Trazodone Hydrochloride	2 in 1 BOTTLE	TABLET, FILM COATED	2	1
12634-193-93	Trazodone Hydrochloride	3 in 1 BOTTLE	TABLET, FILM COATED	3	1
12634-193-94	Trazodone Hydrochloride	4 in 1 BOTTLE	TABLET, FILM COATED	4	1
12634-193-95	Trazodone Hydrochloride	5 in 1 BOTTLE	TABLET, FILM COATED	5	1
12634-193-96	Trazodone Hydrochloride	6 in 1 BOTTLE	TABLET, FILM COATED	6	1
12634-193-97	Trazodone Hydrochloride	7 in 1 BOTTLE	TABLET, FILM COATED	7	1
12634-193-98	Trazodone Hydrochloride	8 in 1 BOTTLE	TABLET, FILM COATED	8	1
12634-193-99	Trazodone Hydrochloride	9 in 1 BOTTLE	TABLET, FILM COATED	9	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12634-193-71	EA - Each	12634-193	f13757be-1d07-47e4-8bc6-4ea85ab2dd51	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-193	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]	1	Legacy NDC, 38 package rows	20170123_467cacc2-646f-342c-e054-00144ff8d46c.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
856377	traZODone HCl 50 MG Oral Tablet	PSN	467cacc2-646f-342c-e054-00144ff8d46c	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	467cacc2-646f-342c-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-193-00	12634019300	10 in 1 BOTTLE	Historical
12634-193-01	12634019301	100 in 1 BOTTLE	Historical
12634-193-09	12634019309	35 in 1 BOTTLE	Historical
12634-193-12	12634019312	120 in 1 BOTTLE	Historical
12634-193-18	12634019318	180 in 1 BOTTLE	Historical
12634-193-40	12634019340	40 in 1 BOTTLE	Historical
12634-193-42	12634019342	42 in 1 BOTTLE	Historical
12634-193-45	12634019345	45 in 1 BOTTLE	Historical
12634-193-50	12634019350	50 in 1 BOTTLE	Historical
12634-193-52	12634019352	12 in 1 BLISTER PACK	Historical
12634-193-54	12634019354	14 in 1 BLISTER PACK	Historical
12634-193-57	12634019357	20 in 1 BLISTER PACK	Historical
12634-193-59	12634019359	30 in 1 BLISTER PACK	Historical
12634-193-60	12634019360	60 in 1 BOTTLE	Historical
12634-193-61	12634019361	10 in 1 BLISTER PACK	Historical
12634-193-63	12634019363	3 in 1 BLISTER PACK	Historical
12634-193-66	12634019366	6 in 1 BLISTER PACK	Historical
12634-193-67	12634019367	7 in 1 BLISTER PACK	Historical
12634-193-69	12634019369	9 in 1 BLISTER PACK	Historical
12634-193-71	12634019371	30 in 1 BOTTLE	Historical
12634-193-74	12634019374	24 in 1 BOTTLE	Historical
12634-193-78	12634019378	28 in 1 BOTTLE	Historical
12634-193-79	12634019379	25 in 1 BOTTLE	Historical
12634-193-80	12634019380	20 in 1 BOTTLE	Historical
12634-193-81	12634019381	21 in 1 BOTTLE	Historical
12634-193-82	12634019382	12 in 1 BOTTLE	Historical
12634-193-84	12634019384	14 in 1 BOTTLE	Historical
12634-193-85	12634019385	15 in 1 BOTTLE	Historical
12634-193-90	12634019390	90 in 1 BOTTLE	Historical
12634-193-91	12634019391	1 in 1 BLISTER PACK	Historical
12634-193-92	12634019392	2 in 1 BOTTLE	Historical
12634-193-93	12634019393	3 in 1 BOTTLE	Historical
12634-193-94	12634019394	4 in 1 BOTTLE	Historical
12634-193-95	12634019395	5 in 1 BOTTLE	Historical
12634-193-96	12634019396	6 in 1 BOTTLE	Historical
12634-193-97	12634019397	7 in 1 BOTTLE	Historical
12634-193-98	12634019398	8 in 1 BOTTLE	Historical
12634-193-99	12634019399	9 in 1 BOTTLE	Historical