Trazodone Hydrochloride

Product NDC: 70518-3426
Requested package NDC: 70518-3426-0
11-digit product format: 705183426
Labeler code: 70518
Product ID: 70518-3426_4f081573-6cdc-8261-e063-6294a90a56bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202180
Marketing category: ANDA
Marketing start: 2022-05-25
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 12 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3426	70518-3426-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Product history page 1 of 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202180-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2013-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2013-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2013-11-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202180-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202180-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202180-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202180-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202180-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202180-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202180-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202180-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202180-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202180-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202180-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202180-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202180-004	AB	1	`d06236e962d9…`

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
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 (package): 70518-3426-0 ndc (product): 70518-3426 ndc11 (package): 70518342600
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
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
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

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	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856373	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
acd077db-e2b8-4d29-94c0-128439050c66	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	Strength	SPL version
70518-3426-0	Trazodone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		7
70518-3426-1	Trazodone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3426	TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241116_acd077db-e2b8-4d29-94c0-128439050c66.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	acd077db-e2b8-4d29-94c0-128439050c66	7
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	acd077db-e2b8-4d29-94c0-128439050c66	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3426-0	70518342600	30 TABLET in 1 BLISTER PACK (70518-3426-0)	30 tablet	2022-05-25	0000-00-00	No	No	Current