Trazodone Hydrochloride

Product NDC: 68382-807
11-digit product format: 683820807
Labeler code: 68382
Product ID: 68382-807_24cb2e4c-a9ba-4283-8396-343f6aa03121
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA205253
Marketing category: ANDA
Marketing start: 2017-12-11
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

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 ndc (product): 68382-807
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

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
704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	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
68382-807-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	9
68382-807-05	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500	9
68382-807-06	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	9
68382-807-10	Trazodone Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	9
68382-807-16	Trazodone Hydrochloride	90 in 1 BOTTLE	TABLET	90	9
68382-807-30	Trazodone Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	9
68382-807-77	Trazodone Hydrochloride	10 in 1 CARTON	TABLET	10	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-807-01	EA - Each	68382-807	f541d095-2cdf-48d4-b22a-dc59e1e51260	1	2018-03-08
68382-807-05	EA - Each	68382-807	9335d8d7-844f-4650-a734-cf89a9faf691	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-807	TRAZODONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 7 package rows	20250503_704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9.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
856364	traZODone HCl 150 MG Oral Tablet	PSN	65ef34fb-8fe4-4e9d-9068-98702515ffeb	103
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	65ef34fb-8fe4-4e9d-9068-98702515ffeb	103
856364	traZODone HCl 150 MG Oral Tablet	PSN	4fcd25d5-e34f-4eea-aeff-aa442651e681	11
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	4fcd25d5-e34f-4eea-aeff-aa442651e681	11
856373	traZODone HCl 100 MG Oral Tablet	PSN	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856373	traZODone HCl 100 MG Oral Tablet	PSN	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856369	traZODone HCl 300 MG Oral Tablet	PSN	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	9
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	2863317d-657b-4dc6-81fb-b7158ea03498	8
856364	traZODone HCl 150 MG Oral Tablet	PSN	bb3ecde6-72ca-450c-ba88-9cf45c808d90	8
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	2863317d-657b-4dc6-81fb-b7158ea03498	8
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	bb3ecde6-72ca-450c-ba88-9cf45c808d90	8
856373	traZODone HCl 100 MG Oral Tablet	PSN	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856364	traZODone HCl 150 MG Oral Tablet	PSN	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856377	traZODone HCl 50 MG Oral Tablet	PSN	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	094ca37b-3ae2-4889-9536-e7e5f20e3105	6
856364	traZODone HCl 150 MG Oral Tablet	PSN	9f1c2bf1-5204-7306-e053-2a95a90a9903	5
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	9f1c2bf1-5204-7306-e053-2a95a90a9903	5
856364	traZODone HCl 150 MG Oral Tablet	PSN	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	traZODone HCl 50 MG Oral Tablet	PSN	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856373	traZODone HCl 100 MG Oral Tablet	PSN	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	8fed1f86-49ab-4747-e053-2a95a90a42b8	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	907d088e-b469-3c34-e053-2a95a90a257a	2
856369	traZODone HCl 300 MG Oral Tablet	PSN	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	8fed1f86-49ab-4747-e053-2a95a90a42b8	2
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	907d088e-b469-3c34-e053-2a95a90a257a	2
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	04a676ee-358e-484d-9de4-a9a88d908ba8	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	04a676ee-358e-484d-9de4-a9a88d908ba8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-807-01	68382080701	100 TABLET in 1 BOTTLE (68382-807-01)	100 tablet	2017-12-11	0000-00-00	No	No	Current
68382-807-05	68382080705	500 TABLET in 1 BOTTLE (68382-807-05)	500 tablet	2017-12-11	0000-00-00	No	No	Current
68382-807-06	68382080706	30 TABLET in 1 BOTTLE (68382-807-06)	30 tablet	2017-12-11	0000-00-00	No	No	Current
68382-807-10	68382080710	1000 TABLET in 1 BOTTLE (68382-807-10)	1000 tablet	2017-12-11	0000-00-00	No	No	Current
68382-807-16	68382080716	90 TABLET in 1 BOTTLE (68382-807-16)	90 tablet	2017-12-11	0000-00-00	No	No	Current
68382-807-30	68382080730	10 in 1 BLISTER PACK						Historical
68382-807-77	68382080777	10 BLISTER PACK in 1 CARTON (68382-807-77) / 10 TABLET in 1 BLISTER PACK (68382-807-30)	10 blister pack	2017-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	REMEDYREPACK INC.	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	9
Trazodone Hydrochloride	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited \| Zydus Pharmaceuticals Limited	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	9
Trazodone Hydrochloride	A-S Medication Solutions	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	11
Trazodone Hydrochloride	AvPAK	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	5
Trazodone Hydrochloride	American Health Packaging	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	6
Trazodone Hydrochloride	Preferred Pharmaceuticals Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	8
Trazodone Hydrochloride	Major Pharmaceuticals	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	9
Trazodone Hydrochloride	Bryant Ranch Prepack	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	103
Trazodone Hydrochloride	Quality Care Products, LLC	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	2
TRAZODONE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
TRAZODONE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
TRAZODONE HYDROCHLORIDE	DIRECT RX	2019-04-25	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy \| Cadila Healthcare Limited	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	2