Trazodone Hydrochloride

Product NDC
50090-2462
Requested package NDC
50090-2462-1
11-digit product format
500902462
Labeler code
50090
Product ID
50090-2462_7761471d-0057-4dd6-b9b7-5e988085f853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071524
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-246250090-2462-1IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A071524-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / 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
A071524-001AB

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 UTC2026-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / 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 UTC2026-02A071524-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071524-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071524-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071524-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071524-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071524-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071524-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071524-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071524-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071524-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071524-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071524-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071524-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071524-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071524-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071524-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071524-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071524-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071524-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071524-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071524-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071524-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071524-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071524-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071524-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071524-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071524-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071524-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071524-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071524-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071524-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071524-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071524-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071524-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071524-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071524-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071524-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071524-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071524-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071524-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2462-0Trazodone Hydrochloride30 in 1 BOTTLETABLET3021
50090-2462-1Trazodone Hydrochloride100 in 1 BOTTLETABLET10021
50090-2462-2Trazodone Hydrochloride60 in 1 BOTTLETABLET6021
50090-2462-3Trazodone Hydrochloride90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2462-0EA - Each50090-246238793fe1-1408-453a-a88b-d866150cc21d12021-09-07
50090-2462-2EA - Each50090-24627bdd8ec0-70d9-4042-8d6f-9a3ba4ae024d12019-03-12
50090-2462-3EA - Each50090-24626f845c8f-e016-4b2b-8ea9-d1bd1d458d0312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2462TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]21Legacy NDC, 4 package rows20210619_d8096ecd-7c99-4db6-915d-2c5dd371a8a4.zip

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 HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsdf17cec9-ad5e-4e57-8572-c927c9b955e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.7bba99e5-4096-4fcb-8591-dc4a9bfe975e2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b617348c-cb19-45df-b313-4ea6af6f1dda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856377traZODone HCl 50 MG Oral TabletPSNd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856373trazodone hydrochloride 100 MG Oral TabletSCDd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856377trazodone hydrochloride 50 MG Oral TabletSCDd8096ecd-7c99-4db6-915d-2c5dd371a8a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2462-150090246201100 TABLET in 1 BOTTLE (50090-2462-1) 100 tablet2018-11-290000-00-00NoNoCurrent