FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
51655-366
11-digit product format
516550366
Labeler code
51655
Product ID
51655-366_49daf198-ebf2-ddd1-e063-6394a90a54d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071523
Marketing category
ANDA
Marketing start
2022-11-30
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856377

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
51655-366-262026-01-29C16284748780-149896155-a023-586f-e063-e6dba90add90These 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
51655-366-522026-01-29C16284748780-149896155-a023-586f-e063-e6dba90add90These 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
51655-366-26Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-366-52Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-366TRAZODONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230306_f2f2290f-b53c-3b38-e053-2995a90a157d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNf2f2290f-b53c-3b38-e053-2995a90a157d3
856377trazodone hydrochloride 50 MG Oral TabletSCDf2f2290f-b53c-3b38-e053-2995a90a157d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-366-265165503662690 TABLET in 1 BOTTLE, PLASTIC (51655-366-26) 90 tablet2023-01-05NoNoCurrent
51655-366-525165503665230 TABLET in 1 BOTTLE, PLASTIC (51655-366-52) 30 tablet2022-11-30NoNoCurrent