Trazodone HCL

Product NDC: 72189-569
11-digit product format: 721890569
Labeler code: 72189
Product ID: 72189-569_1fd0fc6d-5b1d-9f6a-e063-6394a90a3b7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone HCL
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA202180
Marketing category: ANDA
Marketing start: 2024-08-16
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 5 · 172 observed 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
2026-09-14 22:38:34	2026-08	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202180-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202180-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202180-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202180-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202180-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202180-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Trazodone HCL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	300 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856369	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
1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c	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	Strength	SPL version
72189-569-30	Trazodone HCL	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-569-30	EA - Each	72189-569	7459e71d-5953-4d75-9c87-628bb11d01e8	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-569	TRAZODONE HCL TABLET [DIRECT_RX]	1	Current NDC, 1 package rows	20240817_1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	596c3f00-1504-eaed-e063-6294a90a08bb	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1f74b23d-f2eb-4c18-a583-d608b7713694	2026-08-10	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	2026-08-07	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
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 ndc (product): 72189-569
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

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
856369	traZODone HCl 300 MG Oral Tablet	PSN	1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c	1
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-569-30	72189056930	30 TABLET in 1 BOTTLE (72189-569-30)	30 tablet	2024-08-16	No	No	Current