Trazodone Hydrochloride

Product NDC: 68387-166
11-digit product format: 683870166
Labeler code: 68387
Product ID: 68387-166_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA072193
Marketing category: ANDA
Marketing start: 2010-11-17
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68387-166		I	Inactivated by FDA		2026-08-03
excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA		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 · 38 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
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	68387-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68387-166	68387-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072193-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A072193-001	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 2 · 41 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	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A072193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072193-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072193 application number: ANDA072193

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68387-166-30	2019-10-29	C162847	48780-1	960f7f55-d286-8e05-e053-dbdaa90a074a	TRAZODONE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68387-166-30	Trazodone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68387-166-30	EA - Each	68387-166	30973ce5-8b09-4b0f-9226-e3ab054feab9	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-166	TRAZODONE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2	Legacy NDC, 1 package rows	20101223_911802e4-2aeb-4447-99ae-6029cdd2d7dd.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	911802e4-2aeb-4447-99ae-6029cdd2d7dd	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	911802e4-2aeb-4447-99ae-6029cdd2d7dd	2
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	911802e4-2aeb-4447-99ae-6029cdd2d7dd	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	911802e4-2aeb-4447-99ae-6029cdd2d7dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-166-30	68387016630	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAZODONE HYDROCHLORIDE TABLETS, USP	Keltman Pharmaceuticals Inc.	2010-11-17	HUMAN PRESCRIPTION DRUG LABEL	2