Trazodone Hydrochloride

Product NDC
49999-343
Requested package NDC
49999-343-60
11-digit product format
499990343
Labeler code
49999
Product ID
49999-343_b8112bb0-f6d6-477c-bfef-238408d9e6e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA071523
Marketing category
ANDA
Marketing start
2011-12-14
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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49999-34349999-343-60DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49999-34349999-343-60DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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…

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 · 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-343-00EA - Each49999-34393d4fb51-ebfe-485d-ae5d-37428943073712012-07-24
49999-343-15EA - Each49999-343cbe40cf8-1376-4692-948f-bb3cbc92051c12012-07-24
49999-343-30EA - Each49999-343b6a51002-6da5-43af-b6d6-977835ab876e12012-07-24
49999-343-60EA - Each49999-34364fd10b0-7f44-464f-8c9b-9297061c2b1812012-07-24
49999-343-90EA - Each49999-343591e0203-5f17-4b1e-969d-f57c2446264812017-04-05

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-343-604999903436060 TABLET in 1 BOTTLE (49999-343-60) 60 tablet2014-01-240000-00-00NoNoCurrent