Application 205253

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

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 ndc (product): 60760-806
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
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 ndc (product): 50090-4825
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 ndc (product): 50268-776
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 ndc (product): 50090-4283
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 ndc (product): 60687-443 ndc (product): 60687-454 ndc (product): 60687-432
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

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 166 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6868	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6868	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6868	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6868	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6869	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6869	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6869	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7212	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
50090-4281	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4283	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4283	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4283	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4402	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4819	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4820	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4825	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4825	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4825	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5218	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5218	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5218	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5218	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5218	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-776	Trazodone Hydrochloride	Trazodone Hydrochloride	AvPAK	ANDA	Current
50268-776	Trazodone Hydrochloride	Trazodone Hydrochloride	AvPAK	ANDA	Current
50268-776	Trazodone Hydrochloride	Trazodone Hydrochloride	AvPAK	ANDA	Current
55154-8085	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health	ANDA	Current
55154-8085	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-8085	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health	ANDA	Current
55154-8087	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-8087	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-810	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-855	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-855	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-855	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-921	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-921	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
60687-432	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-432	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-432	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-443	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-443	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-443	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-454	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-454	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60687-454	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
60760-806	Trazodone Hydrochloride	Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-806	Trazodone Hydrochloride	Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-806	Trazodone Hydrochloride	Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-807	Trazodone Hydrochloride	Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-473	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-613	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-613	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-613	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-613	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-631	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-631	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-631	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
63629-8139	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8139	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8139	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8140	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-4410	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4410	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4410	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4761	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4761	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4761	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4761	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4833	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current