Trazodone Hydrochloride

Product NDC: 67296-1411
Requested package NDC: 67296-1411-3
11-digit product format: 672961411
Labeler code: 67296
Product ID: 67296-1411_b948b59c-6f26-cb9d-e053-2995a90af495
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA206923
Marketing category: ANDA
Marketing start: 2021-01-01
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1411	67296-1411-3	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 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206923-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08
A206923-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08
A206923-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08
A206923-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206923-001	AB
A206923-002	AB
A206923-003	AB
A206923-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A206923-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206923-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206923-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206923-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206923-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206923-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206923-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206923-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206923-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206923-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206923-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206923-004	AB	1	`5bbf6a4d5a75…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1411-3	2024-08-07	C162847	48780-1	f386c649-9ec2-0266-e053-dadaa90a7c1a	Trazodone 50mg tabs TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
67296-1411-3	2023-01-30	C162847	48780-1	f386c649-9ec2-0266-e053-dadaa90a7c1a	Trazodone 50mg tabs 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	Strength	SPL version
67296-1411-3	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1411	TRAZODONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20240808_b9489fca-1b10-8814-e053-2a95a90acbeb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	5605e909-dc75-4578-94c6-41bb96ba3e2a	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	78c3188c-d42f-4d3d-aa42-3c146dfe08ee	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Accord Healthcare, Inc.	ed3039d8-3d27-4b71-a4b0-812943c9457f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	a90caa68-b28e-425f-b77c-7b566ac17dc2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206923 application number: ANDA206923

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	b9489fca-1b10-8814-e053-2a95a90acbeb	5
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	b9489fca-1b10-8814-e053-2a95a90acbeb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1411-3	67296141103	30 TABLET in 1 BOTTLE (67296-1411-3)	30 tablet	2021-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	5