Trazodone Hydrochloride

Product NDC
53002-4105
11-digit product format
530024105
Labeler code
53002
Product ID
53002-4105_0a824675-ed1f-4af2-a1fc-7a31003ded4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4105-0Trazodone Hydrochloride100 in 1 BOTTLETABLET1001
53002-4105-3Trazodone Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4105TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_c2a5ef88-143a-4426-ae04-af540c3a75fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNc2a5ef88-143a-4426-ae04-af540c3a75fb1
856373trazodone hydrochloride 100 MG Oral TabletSCDc2a5ef88-143a-4426-ae04-af540c3a75fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4105-053002410500100 TABLET in 1 BOTTLE (53002-4105-0) 100 tablet2021-01-010000-00-00NoNoCurrent
53002-4105-35300241050330 TABLET in 1 BOTTLE (53002-4105-3) 30 tablet2021-01-010000-00-00NoNoCurrent