FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-2852
11-digit product format
500902852
Labeler code
50090
Product ID
50090-2852_78807a99-df94-4ca2-8cbd-6897f2fbd66a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071258
Marketing category
ANDA
Marketing start
2008-11-17
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
2019-12-31
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
50090-2852-02020-01-31C16284748780-19d75b9d0-7ea9-f424-e053-dadaa90a57ceThese 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, USP for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2852-0Trazodone Hydrochloride1 in 1 BLISTER PACKTABLET19
50090-2852-0Trazodone Hydrochloride33 in 1 BOX, UNIT-DOSETABLET339

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2852-0EA - Each50090-285203a9576e-be02-4dc6-8545-f9156f0a398812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2852TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Legacy NDC, 2 package rows20190225_2941ca60-43f7-418d-9ea3-4bc2d62dea02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN2941ca60-43f7-418d-9ea3-4bc2d62dea029
856377trazodone hydrochloride 50 MG Oral TabletSCD2941ca60-43f7-418d-9ea3-4bc2d62dea029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2852-0500902852001 in 1 BLISTER PACKHistorical