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 42.

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.

Product history page 1 of 5 · 168 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
2026-08-18 06:07:40	2026-07	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2017-10-10	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205253-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205253-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205253-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205253-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205253-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205253-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205253-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205253-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205253-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205253-004	AB	1	`d8e5a09893c0…`

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

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	American Health Packaging	f715085a-be56-497e-ad92-9fec3aba70b5	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	81a5b557-06f6-2470-e053-2991aa0a64fd	2026-08-06	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	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205253 application number: ANDA205253
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	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	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

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