FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
53217-239
11-digit product format
532170239
Labeler code
53217
Product ID
53217-239_cf46ce00-c9e1-4dc6-bc2b-03e21126b849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071524
Marketing category
ANDA
Marketing start
1990-09-30
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
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
53217-239-282020-01-31C16284748780-19d75b9d0-4489-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, for oral use Initial U.S. Approval: 1981
53217-239-302020-01-31C16284748780-19d75b9d0-4489-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, for oral use Initial U.S. Approval: 1981
53217-239-602020-01-31C16284748780-19d75b9d0-4489-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, for oral use Initial U.S. Approval: 1981
53217-239-902020-01-31C16284748780-19d75b9d0-4489-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, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-239-28Trazodone Hydrochloride28 in 1 BOTTLETABLET281
53217-239-30Trazodone Hydrochloride30 in 1 BOTTLETABLET301
53217-239-60Trazodone Hydrochloride60 in 1 BOTTLETABLET601
53217-239-90Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-239-28EA - Each53217-239ed52dc12-bc03-4a7c-89d6-822ad4e28d1012016-12-07
53217-239-30EA - Each53217-239875d5473-e710-44f9-849a-33dd6972b9b112016-12-07
53217-239-60EA - Each53217-239132c1423-0393-41ea-b336-8bedb3ca418f12016-12-07
53217-239-90EA - Each53217-2392f6318fd-ba43-4f65-99b4-bf0d67ca85d812016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-239TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161207_29e4012e-05bb-4aff-9f20-f0c17a06a29e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN29e4012e-05bb-4aff-9f20-f0c17a06a29e1
856373trazodone hydrochloride 100 MG Oral TabletSCD29e4012e-05bb-4aff-9f20-f0c17a06a29e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-239-285321702392828 in 1 BOTTLEHistorical
53217-239-305321702393030 in 1 BOTTLEHistorical
53217-239-605321702396060 in 1 BOTTLEHistorical
53217-239-905321702399090 in 1 BOTTLEHistorical