Trazodone Hydrochloride

Product NDC
76420-672
11-digit product format
764200672
Labeler code
76420
Product ID
76420-672_1244caf6-4ab7-dd22-e063-6294a90a81bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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
76420-672-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1002
76420-672-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
76420-672-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
76420-672-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-672TRAZODONE HYDROCHLORIDE TABLET [ASCLEMED USA, INC.]2Current NDC, 4 package rows20240228_04a676ee-358e-484d-9de4-a9a88d908ba8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856364traZODone HCl 150 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856369traZODone HCl 300 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856377traZODone HCl 50 MG Oral TabletPSN04a676ee-358e-484d-9de4-a9a88d908ba82
856373trazodone hydrochloride 100 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856364trazodone hydrochloride 150 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856369trazodone hydrochloride 300 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82
856377trazodone hydrochloride 50 MG Oral TabletSCD04a676ee-358e-484d-9de4-a9a88d908ba82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-672-0176420067201100 TABLET in 1 BOTTLE (76420-672-01) 100 tablet2024-02-26NoNoHistorical
76420-672-307642006723030 TABLET in 1 BOTTLE (76420-672-30) 30 tablet2024-02-26NoNoHistorical
76420-672-607642006726060 TABLET in 1 BOTTLE (76420-672-60) 60 tablet2024-02-26NoNoHistorical
76420-672-907642006729090 TABLET in 1 BOTTLE (76420-672-90) 90 tablet2024-02-26NoNoHistorical