FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
60505-2659
11-digit product format
605052659
Labeler code
60505
Product ID
60505-2659_6761bdb4-2041-118d-35a8-4c39a8b20539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA071196
Marketing category
ANDA
Marketing start
2009-01-05
Substance
TRAZODONE HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856364, 856369, 856373, 856377

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2659-1Trazodone Hydrochloride100 in 1 BOTTLETABLET10022
60505-2659-5Trazodone Hydrochloride500 in 1 BOTTLETABLET50022
60505-2659-7Trazodone Hydrochloride1400 in 1 BOTTLETABLET140022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2659-1EA - Each60505-265947d2b163-d9b6-4a77-ba91-d9ec7a53a79912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2659TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP]20Current NDC, Legacy NDC, 3 package rows20250322_71961ab1-951d-1493-f76c-2ff25cca2a85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN71961ab1-951d-1493-f76c-2ff25cca2a8522
856364traZODone HCl 150 MG Oral TabletPSN71961ab1-951d-1493-f76c-2ff25cca2a8522
856369traZODone HCl 300 MG Oral TabletPSN71961ab1-951d-1493-f76c-2ff25cca2a8522
856377traZODone HCl 50 MG Oral TabletPSN71961ab1-951d-1493-f76c-2ff25cca2a8522
856373trazodone hydrochloride 100 MG Oral TabletSCD71961ab1-951d-1493-f76c-2ff25cca2a8522
856364trazodone hydrochloride 150 MG Oral TabletSCD71961ab1-951d-1493-f76c-2ff25cca2a8522
856369trazodone hydrochloride 300 MG Oral TabletSCD71961ab1-951d-1493-f76c-2ff25cca2a8522
856377trazodone hydrochloride 50 MG Oral TabletSCD71961ab1-951d-1493-f76c-2ff25cca2a8522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2659-160505265901100 TABLET in 1 BOTTLE (60505-2659-1) 100 tablet2009-01-050000-00-00NoNoCurrent
60505-2659-560505265905500 TABLET in 1 BOTTLE (60505-2659-5) 500 tablet2009-01-050000-00-00NoNoCurrent
60505-2659-7605052659071400 TABLET in 1 BOTTLE (60505-2659-7) 1400 tablet2009-01-050000-00-00NoNoCurrent