Trazodone Hydrochloride

Product NDC: 53489-511
Requested package NDC: 53489-511-07
11-digit product format: 534890511
Labeler code: 53489
Product ID: 53489-511_a4387b4a-d4d2-48b6-bd6d-e22b69547263
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA073137
Marketing category: ANDA
Marketing start: 1993-03-24
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53489-511	53489-511-07	D	Discontinued by firm		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 1 · 12 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A073137-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24
A073137-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24
A073137-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A073137-001	AB
A073137-002	AB
A073137-003	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 4 · 126 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	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A073137-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073137-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073137-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073137-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-511-01	EA - Each	53489-511	49931279-0321-41ec-84ac-da3644edaee5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Trazodone Hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
Trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
crospovidone	INACTIVE INGREDIENT	68401960MK	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	14

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	Coupler LLC	55f18806-6c23-783b-e063-6294a90acc46	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	4c4ca53e-9201-298c-e063-6294a90a72c6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fa7afa93-b98c-4dc7-bbb8-ab6a058427b9	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	f291b905-a739-5e43-e053-2995a90ac40c	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE	25332-39-2	TRAZODONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-511-07	53489051107	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-511-07)	1993-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	REMEDYREPACK INC.	2019-01-16	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm Inc.	2018-12-05	HUMAN PRESCRIPTION DRUG LABEL	17
Trazodone Hydrochloride	A-S Medication Solutions	2018-01-09	HUMAN PRESCRIPTION DRUG LABEL	12