FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-6121
11-digit product format
500906121
Labeler code
50090
Product ID
50090-6121_cbb77265-5531-4278-b5df-a424c78e427c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206923
Marketing category
ANDA
Marketing start
2018-10-17
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-6121IInactivated by FDA2026-08-03
excluded packagepackage50090-612150090-6121-2IInactivated by FDA2026-08-03
excluded packagepackage50090-612150090-6121-4IInactivated by FDA2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206923-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08
A206923-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08
A206923-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08
A206923-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206923-001AB
A206923-002AB
A206923-003AB
A206923-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206923-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-004AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack5605e909-dc75-4578-94c6-41bb96ba3e2a2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack78c3188c-d42f-4d3d-aa42-3c146dfe08ee2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAccord Healthcare, Inc.ed3039d8-3d27-4b71-a4b0-812943c9457f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPa90caa68-b28e-425f-b77c-7b566ac17dc22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-6121-22024-01-30C16284748780-11030e365-28a1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-6121-42024-01-30C16284748780-11030e365-28a1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6121-2Trazodone Hydrochloride30 in 1 BOTTLETABLET301
50090-6121-4Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6121-2EA - Each50090-61211ae0ac28-05cd-4a3c-ba56-a01b9a2f7a8912022-11-07
50090-6121-4EA - Each50090-6121b20a7363-afa4-44c7-bedc-44b0c79299e712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6121TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20221005_86b4e9c0-d784-448b-8a52-9dd3ca92e2b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN86b4e9c0-d784-448b-8a52-9dd3ca92e2b31
856364trazodone hydrochloride 150 MG Oral TabletSCD86b4e9c0-d784-448b-8a52-9dd3ca92e2b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6121-25009061210230 TABLET in 1 BOTTLE (50090-6121-2) 30 tablet2022-09-300000-00-00NoNoCurrent
50090-6121-45009061210490 TABLET in 1 BOTTLE (50090-6121-4) 90 tablet2022-09-300000-00-00NoNoCurrent