Trazodone Hydrochloride

Product NDC: 53489-510
Requested package NDC: 53489-510-01
11-digit product format: 534890510
Labeler code: 53489
Product ID: 53489-510_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: 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#

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	53489-510	53489-510-01	D	Discontinued by firm		2026-07-31

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A073137-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073137-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073137-003	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 · 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 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-510-01	EA - Each	53489-510	8c2e55f9-09e2-4be9-8310-174f0dea54c3	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
Trazodone Hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
Trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1

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	9426f88d-2f3f-4dc9-ba17-f4bc0be91963	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	9426f88d-2f3f-4dc9-ba17-f4bc0be91963	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-510-01	53489051001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-510-01)	1993-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm Inc.	2018-12-05	HUMAN PRESCRIPTION DRUG LABEL	17
Trazodone Hydrochloride	MedVantx, Inc. \| Mutual Pharmaceutical Company, Inc. \| Blenheim Pharmacal, Inc.	2012-07-01	HUMAN PRESCRIPTION DRUG LABEL	1