Trazodone Hydrochloride

Product NDC: 13668-331
11-digit product format: 136680331
Labeler code: 13668
Product ID: 13668-331_bc2a4de4-8b05-4bb8-bf92-b7f5daa0a6f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA202180
Marketing category: ANDA
Marketing start: 2013-11-27
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A202180-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27
A202180-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27
A202180-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27
A202180-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202180-001	AB
A202180-002	AB
A202180-003	AB
A202180-004	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	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`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	A202180-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-004	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1f74b23d-f2eb-4c18-a583-d608b7713694	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	acd077db-e2b8-4d29-94c0-128439050c66	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180 ndc (product): 13668-331
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f98b1e8f-9c66-3e9c-e053-6294a90ab057	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f7e6a78e-7ac3-35b9-e053-6294a90aabd0	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	adc7427e-3553-4805-b063-eeda84049029	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fc9b90d1-7da5-efc1-e053-6294a90a0223	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29ac7183-e574-506e-e063-6394a90a77c9	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	be0dc037-d30a-4f07-ab7c-1695637b3740	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a71063f9-cdc6-46bc-9eb4-626f288e46d9	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone HCL	TRAZODONE HCL	Direct_Rx	1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c	2024-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Medsource Pharmaceuticals	138fef7b-db83-88c4-e063-6394a90ab0ac	2024-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	3c8c3d2b-9108-40fa-90d9-6ed545cf6549	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	2a1d0989-6ed5-4a2f-bd03-73d61eb40232	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180

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	100 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
1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	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
13668-331-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	13
13668-331-05	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500	13
13668-331-10	Trazodone Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	13
13668-331-30	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-331-01	EA - Each	13668-331	913c2382-e335-4f7f-913f-91b3d65e87f8	1	2014-02-04
13668-331-05	EA - Each	13668-331	18fbd6d1-f83b-40a7-a849-8f79662f46ea	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-331	TRAZODONE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10	Current NDC, Legacy NDC, 4 package rows	20250322_1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7.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	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856364	traZODone HCl 150 MG Oral Tablet	PSN	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856369	traZODone HCl 300 MG Oral Tablet	PSN	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856377	traZODone HCl 50 MG Oral Tablet	PSN	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	13
856373	traZODone HCl 100 MG Oral Tablet	PSN	acd077db-e2b8-4d29-94c0-128439050c66	7
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	acd077db-e2b8-4d29-94c0-128439050c66	7
856373	traZODone HCl 100 MG Oral Tablet	PSN	f7e6a78e-7ac3-35b9-e053-6294a90aabd0	2
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	f7e6a78e-7ac3-35b9-e053-6294a90aabd0	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	138fef7b-db83-88c4-e063-6394a90ab0ac	1
856373	traZODone HCl 100 MG Oral Tablet	PSN	c2a5ef88-143a-4426-ae04-af540c3a75fb	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	138fef7b-db83-88c4-e063-6394a90ab0ac	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	c2a5ef88-143a-4426-ae04-af540c3a75fb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-331-01	13668033101	100 TABLET in 1 BOTTLE (13668-331-01)	100 tablet	2013-11-27	0000-00-00	No	No	Current
13668-331-05	13668033105	500 TABLET in 1 BOTTLE (13668-331-05)	500 tablet	2013-11-27	0000-00-00	No	No	Current
13668-331-10	13668033110	1000 TABLET in 1 BOTTLE (13668-331-10)	1000 tablet	2013-11-27	0000-00-00	No	No	Current
13668-331-30	13668033130	30 TABLET in 1 BOTTLE (13668-331-30)	30 tablet	2013-11-27	0000-00-00	No	No	Current
13668-331-74	13668033174	100 TABLET in 1 CARTON (13668-331-74)	100 tablet	2013-11-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	REMEDYREPACK INC.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	7
Trazodone Hydrochloride	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	13
Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	2025-08-20	HUMAN PRESCRIPTION DRUG LABEL	2
Trazodone Hydrochloride	Medsource Pharmaceuticals \| Torrent Pharma, Inc. \| Torrent Pharmaceuticals Limited	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Trazodone Hydrochloride	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1