Trazodone Hydrochloride

Product NDC: 55700-782
11-digit product format: 557000782
Labeler code: 55700
Product ID: 55700-782_bcb01671-2655-4540-9c86-c97821111877
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA206923
Marketing category: ANDA
Marketing start: 2019-08-09
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-782		D	Discontinued by firm		2026-08-03
excluded package	package	55700-782	55700-782-30	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 · 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.

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	A206923-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-09-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-09-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-09-08	`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	A206923-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206923-004	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	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-782-30	EA - Each	55700-782	bf03991f-a441-402d-bf27-25d2b2368aaf	1	2019-09-05

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-782-30	55700078230	30 TABLET in 1 BOTTLE (55700-782-30)	30 tablet	2019-08-09	0000-00-00	No	No	Current