Application 202180

Type: ANDA
Sponsor: TORRENT

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
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.

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	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`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	A202180-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202180-004	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1f74b23d-f2eb-4c18-a583-d608b7713694	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180 ndc (product): 70518-3479
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	acd077db-e2b8-4d29-94c0-128439050c66	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202180 application number: ANDA202180 ndc (product): 70518-3426
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 ndc (product): 13668-330 ndc (product): 13668-332 ndc (product): 13668-333 ndc (product): 13668-331
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 ndc (product): 71335-2084
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
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 ndc (product): 71205-505

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-330	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-330	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-330	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-330	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-330	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-331	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-331	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-331	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-331	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-331	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-332	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-332	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-332	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-332	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-332	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-333	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-333	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-333	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-333	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-333	Trazodone Hydrochloride	Trazodone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
53002-2132	Trazodone Hydrochloride	Trazodone Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4105	Trazodone Hydrochloride	Trazodone Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-957	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-957	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-957	Trazodone Hydrochloride	Trazodone Hydrochloride	Quality Care Products, LLC	ANDA	Current
70518-3426	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3479	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-817	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-505	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71205-505	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71335-2084	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current