TRAZODONE HYDROCHLORIDE

Product NDC: 13107-079
11-digit product format: 131070079
Labeler code: 13107
Product ID: 13107-079_db4e6aff-149f-4f16-9512-e81e0c3e6900
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAZODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA204852
Marketing category: ANDA
Marketing start: 2015-09-15
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 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 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
A204852-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05
A204852-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05
A204852-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05
A204852-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204852-001	AB
A204852-002	AB
A204852-003	AB
A204852-004	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	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`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	A204852-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-004	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fec78f5d-2567-44d3-9f04-1a6913357019	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	34986e81-da05-46c1-8dd6-1dd7a8d1a44f	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f89ad429-0056-e4d6-e053-6294a90a7ab1	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	470a98a2-4e68-4c98-b3c8-e5eba4e55cdc	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	fdd35113-5f51-49c5-a29c-ffdddd28ef38	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	b57daea8-5a39-41c1-842e-b1d15115e36f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	24b5eee4-4210-4b90-a695-11e6a5868988	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	7baa8eef-3a5c-43b3-a5fe-0c449aacda2e	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	4370fe5c-1c40-499b-abb5-bca0a39834c6	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a343910a-bf4c-4a41-b0ee-0e90e8355815	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	1514b3b0-7742-4247-b9fd-ea14849d3fdd	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	b0a79ee7-3140-48cb-b734-244a4420e32c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC	295e92a9-bcb0-4d53-ba62-e30020e9834b	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852 ndc (product): 13107-079
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca6faa-316d-5754-e063-6394a90a7eff	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8fc1f03-cd9d-9fa9-e053-6294a90a8665	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852

Additional Listing Data#

Finished product: Yes
Brand name base: TRAZODONE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	50 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
295e92a9-bcb0-4d53-ba62-e30020e9834b	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
13107-079-01	TRAZODONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	9
13107-079-05	TRAZODONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	9
13107-079-30	TRAZODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	9
13107-079-99	TRAZODONE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-079-01	EA - Each	13107-079	c280dcde-a124-47b5-9200-4d22953bd1c3	1	2021-12-08
13107-079-05	EA - Each	13107-079	0031e3ac-a777-4cc3-8c5d-d553492a1c3c	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-079	TRAZODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]	9	Current NDC, Legacy NDC, 4 package rows	20250412_295e92a9-bcb0-4d53-ba62-e30020e9834b.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	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856369	traZODone HCl 300 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	30ca6faa-316d-5754-e063-6394a90a7eff	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	b0a79ee7-3140-48cb-b734-244a4420e32c	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	30ca6faa-316d-5754-e063-6394a90a7eff	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	b0a79ee7-3140-48cb-b734-244a4420e32c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-079-01	13107007901	100 TABLET in 1 BOTTLE (13107-079-01)	100 tablet	2015-09-15	0000-00-00	No	No	Current
13107-079-05	13107007905	500 TABLET in 1 BOTTLE (13107-079-05)	500 tablet	2015-09-15	0000-00-00	No	No	Current
13107-079-30	13107007930	30 TABLET in 1 BOTTLE (13107-079-30)	30 tablet	2015-09-15	0000-00-00	No	No	Current
13107-079-99	13107007999	1000 TABLET in 1 BOTTLE (13107-079-99)	1000 tablet	2015-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	2025-08-14	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-04-02	Human Prescription Drug Label	9
TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1