FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
61919-473
11-digit product format
619190473
Labeler code
61919
Product ID
61919-473_ea4e7175-9459-6be8-e053-2a95a90a507c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA205253
Marketing category
ANDA
Marketing start
2019-08-19
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
61919-473-302025-01-31C16284748780-11030e365-3aa2-111a-e063-dadaa90a10e2TRAZODONE HYDROCHLORIDE
61919-473-602025-01-30C16284748780-12cef2736-945f-d83d-e063-dadaa90ab31fTRAZODONE HYDROCHLORIDE
61919-473-902025-01-30C16284748780-12cef2736-9153-d83d-e063-dadaa90ab31fTRAZODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-473-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET303
61919-473-60TRAZODONE HYDROCHLORIDE60 in 1 BOTTLETABLET602
61919-473-90TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-473-30EA - Each61919-473340e5a6a-a973-4aaa-b650-fdd23d26c83812018-04-19
61919-473-60EA - Each61919-4730ef9cb64-1052-49a0-b17b-5d76ffccaabf12019-09-05
61919-473-90EA - Each61919-473d62ad966-fc61-4aa2-972a-9f0b6d7e526112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-473TRAZODONE HYDROCHLORIDE TABLET TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20190425_66da652a-72b4-c17f-e053-2a91aa0a8d69.zip
61919-473TRAZODONE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8fed1f86-49ab-4747-e053-2a95a90a42b8.zip
61919-473TRAZODONE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_907d088e-b469-3c34-e053-2a95a90a257a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856377traZODone HCl 50 MG Oral TabletPSN66da652a-72b4-c17f-e053-2a91aa0a8d693
856364trazodone hydrochloride 150 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856377trazodone hydrochloride 50 MG Oral TabletSCD66da652a-72b4-c17f-e053-2a91aa0a8d693
856364traZODone HCl 150 MG Oral TabletPSN8fed1f86-49ab-4747-e053-2a95a90a42b82
856364traZODone HCl 150 MG Oral TabletPSN907d088e-b469-3c34-e053-2a95a90a257a2
856364trazodone hydrochloride 150 MG Oral TabletSCD8fed1f86-49ab-4747-e053-2a95a90a42b82
856364trazodone hydrochloride 150 MG Oral TabletSCD907d088e-b469-3c34-e053-2a95a90a257a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-473-306191904733030 TABLET in 1 BOTTLE (61919-473-30) 30 tablet2018-03-070000-00-00NoNoCurrent
61919-473-606191904736060 TABLET in 1 BOTTLE (61919-473-60) 60 tablet2019-08-120000-00-00NoNoCurrent
61919-473-906191904739090 TABLET in 1 BOTTLE (61919-473-90) 90 tablet2019-08-190000-00-00NoNoCurrent