Trazodone Hydrochloride

Product NDC
45865-167
11-digit product format
458650167
Labeler code
45865
Product ID
45865-167_12f16727-8822-5b6c-e063-6394a90a02a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-167-30Trazodone Hydrochloride30 in 1 BOTTLETABLET301
45865-167-60Trazodone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-167TRAZODONE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1Current NDC, 2 package rows20240308_12f1737b-c021-d0f2-e063-6294a90a6f29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN12f1737b-c021-d0f2-e063-6294a90a6f291
856377trazodone hydrochloride 50 MG Oral TabletSCD12f1737b-c021-d0f2-e063-6294a90a6f291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45865-167-304586501673030 TABLET in 1 BOTTLE (45865-167-30) 30 tablet2021-09-08NoNoCurrent
45865-167-604586501676060 TABLET in 1 BOTTLE (45865-167-60) 60 tablet2021-04-08NoNoCurrent