Trazodone Hydrochloride

Product NDC: 60505-2655
Requested package NDC: 60505-2655-5
11-digit product format: 605052655
Labeler code: 60505
Product ID: 60505-2655_6761bdb4-2041-118d-35a8-4c39a8b20539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp
Application: ANDA071196
Marketing category: ANDA
Marketing start: 2008-11-17
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	60505-2655	60505-2655-5	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	RLD / RS	Approval date
A071196-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25
A071196-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26
A071196-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071196-001	AB
A071196-002	AB
A071196-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A071196-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	1987-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A071196-002	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		1999-04-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A071196-003	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1999-04-26	`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	A071196-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A071196-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A071196-003	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	REMEDYREPACK INC.	dc1f347e-1acb-4c06-b36e-f15fecb7ac93	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Apotex Corp	71961ab1-951d-1493-f76c-2ff25cca2a85	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196 ndc (package): 60505-2655-5 ndc (product): 60505-2655 ndc11 (package): 60505265505
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5d22a06c-9cb8-4b49-8d67-769d181ad70c	2021-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	9c4da6ad-d4d1-4e8c-918d-8ac48512a93f	2020-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071196 application number: ANDA071196

Additional Listing Data#

Finished product: Yes
Brand name base: Trazodone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6E8ZO8LRNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856364	Internal RxNorm lookup
856369	Internal RxNorm lookup
856373	Internal RxNorm lookup
856377	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71961ab1-951d-1493-f76c-2ff25cca2a85	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-2655-1	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	22
60505-2655-5	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500	22
60505-2655-7	Trazodone Hydrochloride	5500 in 1 BOTTLE	TABLET	5500	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-2655-1	EA - Each	60505-2655	0b24da77-ae5c-42f9-aa30-9ed8775ecc71	1	2012-07-24
60505-2655-5	EA - Each	60505-2655	606c6440-0eca-439a-abbc-2d2176a9b736	1	2012-07-24
60505-2655-7	EA - Each	60505-2655	9ba4253b-6ac8-47c8-af5d-2868bc08db61	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 [APOTEX CORP]	8
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	8
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
trazodone hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
trazodone hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-2655	TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]	20	Current NDC, Legacy NDC, 3 package rows	20250322_71961ab1-951d-1493-f76c-2ff25cca2a85.zip

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
856373	traZODone HCl 100 MG Oral Tablet	PSN	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856364	traZODone HCl 150 MG Oral Tablet	PSN	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856369	traZODone HCl 300 MG Oral Tablet	PSN	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856377	traZODone HCl 50 MG Oral Tablet	PSN	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	71961ab1-951d-1493-f76c-2ff25cca2a85	22
856364	traZODone HCl 150 MG Oral Tablet	PSN	0f7d09d5-3e31-07a7-e054-00144ff8d46c	1
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	0f7d09d5-3e31-07a7-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-2655-5	60505265505	500 TABLET in 1 BOTTLE (60505-2655-5)	500 tablet	2008-11-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Apotex Corp	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	22
Trazodone Hydrochloride	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	22
Trazodone Hydrochloride	Golden State Medical Supply, Inc. \| Apotex Inc.	2020-10-14	HUMAN PRESCRIPTION DRUG LABEL	7
Trazodone Hydrochloride	REMEDYREPACK INC.	2019-08-21	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	American Health Packaging	2019-05-06	HUMAN PRESCRIPTION DRUG LABEL	4
Trazodone Hydrochloride	Blenheim Pharmacal, Inc.	2015-02-19	HUMAN PRESCRIPTION DRUG LABEL	1