Trazodone Hydrochloride

Product NDC
66267-205
11-digit product format
662670205
Labeler code
66267
Product ID
66267-205_9cbdca10-e4ae-e586-e053-2a95a90a8ecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA071523
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-205DDiscontinued by firm2026-08-03
excluded packagepackage66267-20566267-205-30DDiscontinued by firm2026-08-03
excluded packagepackage66267-20566267-205-60DDiscontinued by firm2026-08-03
excluded packagepackage66267-20566267-205-90DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-205-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-205-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-205-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-205-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-205-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-205-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-205-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-205-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-205-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-205-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-205-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-205-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-205-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-205-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-205-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-205-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-205-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-205-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-205-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-205-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-205-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-205-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-205-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-205-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-205-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-205-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-205-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-205-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-205-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-205-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-205-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-205-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-205-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-205-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-205-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-205-60557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071523-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071523-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071523-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071523-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071523-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071523-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071523-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071523-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071523-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071523-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071523-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071523-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071523-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071523-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071523-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071523-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071523-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071523-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071523-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071523-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071523-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071523-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071523-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071523-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071523-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071523-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071523-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071523-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071523-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071523-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071523-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071523-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071523-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071523-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071523-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071523-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071523-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071523-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071523-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071523-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071523-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071523-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-205-30EA - Each66267-205e4ea4996-a3c7-48f0-9f49-ff959c1987c212016-11-08
66267-205-60EA - Each66267-20536cc12c8-211d-40b8-8136-ed0703b6c4b712016-11-08
66267-205-90EA - Each66267-205f2d1db28-6a53-4aae-a6dc-1b8d63e6e91712016-11-08

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEUnit Dose Solutions, Inc.562fdfb9-c060-63bc-e063-6294a90ad8402026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.38e9820a-6edc-4bf5-b5e4-034b9e48b5832026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCf2f2290f-b53c-3b38-e053-2995a90a157d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523