FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-1561
11-digit product format
500901561
Labeler code
50090
Product ID
50090-1561_7761471d-0057-4dd6-b9b7-5e988085f853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071523
Marketing category
ANDA
Marketing start
1990-09-30
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
2022-12-31
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
50090-1561-02023-01-30C16284748780-1f386c64a-2712-0266-e053-dadaa90a7c1aThese 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
50090-1561-12023-01-30C16284748780-1f386c64a-2712-0266-e053-dadaa90a7c1aThese 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
50090-1561-62023-01-30C16284748780-1f386c64a-2712-0266-e053-dadaa90a7c1aThese 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
50090-1561-82023-01-30C16284748780-1f386c64a-2712-0266-e053-dadaa90a7c1aThese 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
50090-1561-92023-01-30C16284748780-1f386c64a-2712-0266-e053-dadaa90a7c1aThese 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
50090-1561-0Trazodone Hydrochloride30 in 1 BOTTLETABLET3021
50090-1561-1Trazodone Hydrochloride100 in 1 BOTTLETABLET10021
50090-1561-6Trazodone Hydrochloride60 in 1 BOTTLETABLET6021
50090-1561-8Trazodone Hydrochloride45 in 1 BOTTLETABLET4521
50090-1561-9Trazodone Hydrochloride90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1561-0EA - Each50090-156122832c5e-6557-48ce-8d7d-678cdae7231512021-09-07
50090-1561-1EA - Each50090-15612b54a598-d4e0-497e-a5bd-2a22233ddd9112021-09-07
50090-1561-6EA - Each50090-156155a45862-f1d5-4467-a0fb-e5eb286d1a3412021-09-07
50090-1561-8EA - Each50090-1561a3ffb621-2a00-49d2-95eb-13674c6a6e7612021-09-07
50090-1561-9EA - Each50090-1561567f950d-2c12-4de0-bee0-84c8696aafba12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1561TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]21Legacy NDC, 5 package rows20210619_d8096ecd-7c99-4db6-915d-2c5dd371a8a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856377traZODone HCl 50 MG Oral TabletPSNd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856373trazodone hydrochloride 100 MG Oral TabletSCDd8096ecd-7c99-4db6-915d-2c5dd371a8a421
856377trazodone hydrochloride 50 MG Oral TabletSCDd8096ecd-7c99-4db6-915d-2c5dd371a8a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1561-05009015610030 TABLET in 1 BOTTLE (50090-1561-0) 30 tablet2014-12-190000-00-00NoNoCurrent
50090-1561-150090156101100 TABLET in 1 BOTTLE (50090-1561-1) 100 tablet2014-12-190000-00-00NoNoCurrent
50090-1561-65009015610660 TABLET in 1 BOTTLE (50090-1561-6) 60 tablet2014-12-190000-00-00NoNoCurrent
50090-1561-85009015610845 TABLET in 1 BOTTLE (50090-1561-8) 45 tablet2014-12-190000-00-00NoNoCurrent
50090-1561-95009015610990 TABLET in 1 BOTTLE (50090-1561-9) 90 tablet2014-12-190000-00-00NoNoCurrent