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

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