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#

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	53489-511	53489-511-07	D	Discontinued by firm		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 · 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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073137-001	AB	1	`8072bd15b7f6…`

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 · 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

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

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