FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
12634-193
11-digit product format
126340193
Labeler code
12634
Product ID
12634-193_467cacc2-6470-342c-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA072192
Marketing category
ANDA
Marketing start
2010-05-30
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
12634-193-002020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-012020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-092020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-122020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-182020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-402020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-422020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-452020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-502020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-522020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-542020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-572020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-592020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-602020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-612020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-632020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-662020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-672020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-692020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-712020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-742020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-782020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-792020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-802020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-812020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-822020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-842020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-852020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-902020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-912020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-922020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-932020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-942020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-952020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-962020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-972020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-982020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981
12634-193-992020-01-31C16284748780-19d75b9d0-c811-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Trazodone hydrochloride tablets USP safely and effectively. See full prescribing information for Trazodone hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-193-00Trazodone Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
12634-193-01Trazodone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
12634-193-09Trazodone Hydrochloride35 in 1 BOTTLETABLET, FILM COATED351
12634-193-12Trazodone Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
12634-193-18Trazodone Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
12634-193-40Trazodone Hydrochloride40 in 1 BOTTLETABLET, FILM COATED401
12634-193-42Trazodone Hydrochloride42 in 1 BOTTLETABLET, FILM COATED421
12634-193-45Trazodone Hydrochloride45 in 1 BOTTLETABLET, FILM COATED451
12634-193-50Trazodone Hydrochloride50 in 1 BOTTLETABLET, FILM COATED501
12634-193-52Trazodone Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED121
12634-193-54Trazodone Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED141
12634-193-57Trazodone Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED201
12634-193-59Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301
12634-193-60Trazodone Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
12634-193-61Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED101
12634-193-63Trazodone Hydrochloride3 in 1 BLISTER PACKTABLET, FILM COATED31
12634-193-66Trazodone Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED61
12634-193-67Trazodone Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED71
12634-193-69Trazodone Hydrochloride9 in 1 BLISTER PACKTABLET, FILM COATED91
12634-193-71Trazodone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
12634-193-74Trazodone Hydrochloride24 in 1 BOTTLETABLET, FILM COATED241
12634-193-78Trazodone Hydrochloride28 in 1 BOTTLETABLET, FILM COATED281
12634-193-79Trazodone Hydrochloride25 in 1 BOTTLETABLET, FILM COATED251
12634-193-80Trazodone Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
12634-193-81Trazodone Hydrochloride21 in 1 BOTTLETABLET, FILM COATED211
12634-193-82Trazodone Hydrochloride12 in 1 BOTTLETABLET, FILM COATED121
12634-193-84Trazodone Hydrochloride14 in 1 BOTTLETABLET, FILM COATED141
12634-193-85Trazodone Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
12634-193-90Trazodone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
12634-193-91Trazodone Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11
12634-193-92Trazodone Hydrochloride2 in 1 BOTTLETABLET, FILM COATED21
12634-193-93Trazodone Hydrochloride3 in 1 BOTTLETABLET, FILM COATED31
12634-193-94Trazodone Hydrochloride4 in 1 BOTTLETABLET, FILM COATED41
12634-193-95Trazodone Hydrochloride5 in 1 BOTTLETABLET, FILM COATED51
12634-193-96Trazodone Hydrochloride6 in 1 BOTTLETABLET, FILM COATED61
12634-193-97Trazodone Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
12634-193-98Trazodone Hydrochloride8 in 1 BOTTLETABLET, FILM COATED81
12634-193-99Trazodone Hydrochloride9 in 1 BOTTLETABLET, FILM COATED91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-193-71EA - Each12634-193f13757be-1d07-47e4-8bc6-4ea85ab2dd5112017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-193TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]1Legacy NDC, 38 package rows20170123_467cacc2-646f-342c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN467cacc2-646f-342c-e054-00144ff8d46c1
856377trazodone hydrochloride 50 MG Oral TabletSCD467cacc2-646f-342c-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-193-001263401930010 in 1 BOTTLEHistorical
12634-193-0112634019301100 in 1 BOTTLEHistorical
12634-193-091263401930935 in 1 BOTTLEHistorical
12634-193-1212634019312120 in 1 BOTTLEHistorical
12634-193-1812634019318180 in 1 BOTTLEHistorical
12634-193-401263401934040 in 1 BOTTLEHistorical
12634-193-421263401934242 in 1 BOTTLEHistorical
12634-193-451263401934545 in 1 BOTTLEHistorical
12634-193-501263401935050 in 1 BOTTLEHistorical
12634-193-521263401935212 in 1 BLISTER PACKHistorical
12634-193-541263401935414 in 1 BLISTER PACKHistorical
12634-193-571263401935720 in 1 BLISTER PACKHistorical
12634-193-591263401935930 in 1 BLISTER PACKHistorical
12634-193-601263401936060 in 1 BOTTLEHistorical
12634-193-611263401936110 in 1 BLISTER PACKHistorical
12634-193-63126340193633 in 1 BLISTER PACKHistorical
12634-193-66126340193666 in 1 BLISTER PACKHistorical
12634-193-67126340193677 in 1 BLISTER PACKHistorical
12634-193-69126340193699 in 1 BLISTER PACKHistorical
12634-193-711263401937130 in 1 BOTTLEHistorical
12634-193-741263401937424 in 1 BOTTLEHistorical
12634-193-781263401937828 in 1 BOTTLEHistorical
12634-193-791263401937925 in 1 BOTTLEHistorical
12634-193-801263401938020 in 1 BOTTLEHistorical
12634-193-811263401938121 in 1 BOTTLEHistorical
12634-193-821263401938212 in 1 BOTTLEHistorical
12634-193-841263401938414 in 1 BOTTLEHistorical
12634-193-851263401938515 in 1 BOTTLEHistorical
12634-193-901263401939090 in 1 BOTTLEHistorical
12634-193-91126340193911 in 1 BLISTER PACKHistorical
12634-193-92126340193922 in 1 BOTTLEHistorical
12634-193-93126340193933 in 1 BOTTLEHistorical
12634-193-94126340193944 in 1 BOTTLEHistorical
12634-193-95126340193955 in 1 BOTTLEHistorical
12634-193-96126340193966 in 1 BOTTLEHistorical
12634-193-97126340193977 in 1 BOTTLEHistorical
12634-193-98126340193988 in 1 BOTTLEHistorical
12634-193-99126340193999 in 1 BOTTLEHistorical