Trazodone Hydrochloride

Product NDC: 55700-855
11-digit product format: 557000855
Labeler code: 55700
Product ID: 55700-855_f392f8d4-600d-4c98-b60b-47362fd0721f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA205253
Marketing category: ANDA
Marketing start: 2020-04-03
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: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-855		D	Discontinued by firm	2026-07-31
excluded package	package	55700-855	55700-855-30	D	Discontinued by firm	2026-07-31
excluded package	package	55700-855	55700-855-60	D	Discontinued by firm	2026-07-31
excluded package	package	55700-855	55700-855-90	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205253-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10
A205253-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10
A205253-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10
A205253-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205253-001	AB
A205253-002	AB
A205253-003	AB
A205253-004	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	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`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	A205253-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205253-004	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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	2863317d-657b-4dc6-81fb-b7158ea03498	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	007f38e0-653b-43e4-a1c1-b59997b2762a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	68bcae4b-f4c3-4d28-af76-d182b707fc73	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	American Health Packaging	f715085a-be56-497e-ad92-9fec3aba70b5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	614f2c6e-0bb7-43e0-85d8-5eef8eeae208	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	04c287ca-5efa-469d-ab39-ff16d9b1e0b3	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	6aaf08aa-9aa3-aabd-e053-2a91aa0a86d1	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	0545507a-5c11-4451-872a-d2f7f0aaecd4	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	a31d59ed-5949-4f85-8b73-3bfd7f72d5b8	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	51e1ef06-d2c8-46db-a2b4-f20d4cc1abf3	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	297cdf27-5b6e-4665-93f9-8fc6aef483a0	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Zydus Lifesciences Limited	43d4be17-5fae-4326-a5c4-9e25e2db6a43	2026-01-23		Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	4fcd25d5-e34f-4eea-aeff-aa442651e681	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvPAK	9f1c2bf1-5204-7306-e053-2a95a90a9903	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	353e66cc-98ca-4500-97e7-00f23f122349	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b716575a-5b96-49c5-bcb2-56b05fbb7920	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	American Health Packaging	094ca37b-3ae2-4889-9536-e7e5f20e3105	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	bb3ecde6-72ca-450c-ba88-9cf45c808d90	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	67d2a90a-3036-409c-aa32-937c55076547	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-855-30	EA - Each	55700-855	8ba92257-ecf3-44a9-a80c-b18a669c0ca9	1	2020-05-08
55700-855-60	EA - Each	55700-855	7684c304-1109-45ab-b95f-3fb217254a2b	1	2020-05-08
55700-855-90	EA - Each	55700-855	aba86714-1f33-4733-9c24-0626a5f5ae62	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-855	TRAZODONE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS, LLC]	7	Legacy NDC	20241220_22f6618e-82ae-4474-a472-d966222d8ffb.zip

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
55700-855-30	55700085530	30 TABLET in 1 BOTTLE (55700-855-30)	30 tablet	2020-04-03	0000-00-00	No	No	Current
55700-855-60	55700085560	60 TABLET in 1 BOTTLE (55700-855-60)	60 tablet	2020-04-03	0000-00-00	No	No	Current
55700-855-90	55700085590	90 TABLET in 1 BOTTLE (55700-855-90)	90 tablet	2021-09-10	0000-00-00	No	No	Current