Trazodone Hydrochloride

Product NDC: 70518-1410
11-digit product format: 705181410
Labeler code: 70518
Product ID: 70518-1410_7f9fcbe8-8a8a-5224-e053-2a91aa0a86fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA071258
Marketing category: ANDA
Marketing start: 2018-09-11
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1410		D	Discontinued by firm		2026-08-17
excluded package	package	70518-1410	70518-1410-0	D	Discontinued by firm		2026-08-17

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
A071258-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1987-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071258-001	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	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071258-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-03-25	`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	A071258-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071258-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071258-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071258-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071258-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071258-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071258-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071258-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071258-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071258-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071258-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071258-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071258-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071258-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071258-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071258-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071258-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071258-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071258-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071258-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071258-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071258-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071258-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071258-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071258-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071258-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071258-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071258-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071258-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071258-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071258-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071258-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071258-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071258-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071258-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071258-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071258-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071258-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071258-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071258-001	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1410	TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	7	Legacy NDC	20250223_1560b731-2379-4055-a63f-a7b92e6b7abc.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	Apotex Corp	71961ab1-951d-1493-f76c-2ff25cca2a85	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071258 application number: ANDA071258
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): 071258 application number: ANDA071258