FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
51407-947
11-digit product format
514070947
Labeler code
51407
Product ID
51407-947_51011392-daab-f55e-e063-6394a90ada3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA218988
Marketing category
ANDA
Marketing start
2024-08-08
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856373, 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
51407-947-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1001
51407-947-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5001
51407-947-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10001
51407-947-90Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856377traZODone HCl 50 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856373trazodone hydrochloride 100 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1
856377trazodone hydrochloride 50 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-947-0151407094701100 TABLET in 1 BOTTLE (51407-947-01) 100 tablet2026-04-28NoNoHistorical
51407-947-0551407094705500 TABLET in 1 BOTTLE (51407-947-05) 500 tablet2026-04-28NoNoHistorical
51407-947-10514070947101000 TABLET in 1 BOTTLE (51407-947-10) 1000 tablet2026-04-28NoNoHistorical
51407-947-905140709479090 TABLET in 1 BOTTLE (51407-947-90) 90 tablet2026-04-28NoNoHistorical