Trazodone Hydrochloride

Product NDC
0615-8339
11-digit product format
006158339
Labeler code
0615
Product ID
0615-8339_1299ffe9-22b8-40af-8cf3-eca9cfcda21c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA071525
Marketing category
ANDA
Marketing start
2020-03-11
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856364, 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
0615-8339-05Trazodone Hydrochloride15 in 1 BLISTER PACKTABLET1512
0615-8339-39Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8339TRAZODONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]9Current NDC, Legacy NDC, 2 package rows20240828_310c4b81-d2cf-4014-873d-e71d036105de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN310c4b81-d2cf-4014-873d-e71d036105de12
856377traZODone HCl 50 MG Oral TabletPSN310c4b81-d2cf-4014-873d-e71d036105de12
856364trazodone hydrochloride 150 MG Oral TabletSCD310c4b81-d2cf-4014-873d-e71d036105de12
856377trazodone hydrochloride 50 MG Oral TabletSCD310c4b81-d2cf-4014-873d-e71d036105de12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8339-050061583390515 TABLET in 1 BLISTER PACK (0615-8339-05) 15 tablet2023-08-23NoNoHistorical
0615-8339-390061583393930 TABLET in 1 BLISTER PACK (0615-8339-39) 30 tablet2022-01-270000-00-00NoNoCurrent