Trazodone Hydrochloride

Product NDC: 53002-1105
Requested package NDC: 53002-1105-3
11-digit product format: 530021105
Labeler code: 53002
Product ID: 53002-1105_994e9daa-4a90-4963-badc-c9d7c8de7b68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
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#

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	53002-1105	53002-1105-3	I	Inactivated by FDA		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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071524-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A071524-001	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-04-22	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

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1105-0	2025-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-3	2025-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-6	2025-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-0	2023-06-07	C162847	48780-1	9d75b9d0-f997-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
53002-1105-3	2023-06-07	C162847	48780-1	9d75b9d0-f997-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
53002-1105-6	2023-06-07	C162847	48780-1	9d75b9d0-f997-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
53002-1105-0	2023-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-3	2023-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-6	2023-01-30	C162847	48780-1	9d75b9d0-f997-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
53002-1105-0	2020-12-15	C162847	48780-1	9d75b9d0-f997-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
53002-1105-3	2020-12-15	C162847	48780-1	9d75b9d0-f997-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
53002-1105-6	2020-12-15	C162847	48780-1	9d75b9d0-f997-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
53002-1105-0	2020-01-31	C162847	48780-1	9d75b9d0-f997-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
53002-1105-3	2020-01-31	C162847	48780-1	9d75b9d0-f997-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
53002-1105-6	2020-01-31	C162847	48780-1	9d75b9d0-f997-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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1105-0	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	7
53002-1105-3	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	7
53002-1105-6	Trazodone Hydrochloride	60 in 1 BOTTLE	TABLET	60	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1105	TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]	7	Legacy NDC, 3 package rows	20230609_8c859876-6b45-45b3-9eb2-5c7a5ea7a26f.zip

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	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856377	traZODone HCl 50 MG Oral Tablet	PSN	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1105-3	53002110503	30 TABLET in 1 BOTTLE (53002-1105-3)	30 tablet	2018-10-01	0000-00-00	No	No	Current