FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71335-2651
11-digit product format
713352651
Labeler code
71335
Product ID
71335-2651_aa842ba3-79c6-4dbc-888e-31b36c5dabe5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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
71335-2651-0Trazodone Hydrochloride14 in 1 BOTTLETABLET141
71335-2651-1Trazodone Hydrochloride20 in 1 BOTTLETABLET201
71335-2651-2Trazodone Hydrochloride30 in 1 BOTTLETABLET301
71335-2651-3Trazodone Hydrochloride60 in 1 BOTTLETABLET601
71335-2651-4Trazodone Hydrochloride90 in 1 BOTTLETABLET901
71335-2651-5Trazodone Hydrochloride45 in 1 BOTTLETABLET451
71335-2651-6Trazodone Hydrochloride100 in 1 BOTTLETABLET1001
71335-2651-7Trazodone Hydrochloride25 in 1 BOTTLETABLET251
71335-2651-8Trazodone Hydrochloride120 in 1 BOTTLETABLET1201
71335-2651-9Trazodone Hydrochloride28 in 1 BOTTLETABLET281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNadc7427e-3553-4805-b063-eeda840490291
856377trazodone hydrochloride 50 MG Oral TabletSCDadc7427e-3553-4805-b063-eeda840490291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2651-07133526510014 TABLET in 1 BOTTLE (71335-2651-0) 14 tablet2025-06-03NoNoCurrent
71335-2651-17133526510120 TABLET in 1 BOTTLE (71335-2651-1) 20 tablet2025-06-03NoNoCurrent
71335-2651-27133526510230 TABLET in 1 BOTTLE (71335-2651-2) 30 tablet2025-06-03NoNoCurrent
71335-2651-37133526510360 TABLET in 1 BOTTLE (71335-2651-3) 60 tablet2025-06-03NoNoCurrent
71335-2651-47133526510490 TABLET in 1 BOTTLE (71335-2651-4) 90 tablet2025-06-03NoNoCurrent
71335-2651-57133526510545 TABLET in 1 BOTTLE (71335-2651-5) 45 tablet2025-06-03NoNoCurrent
71335-2651-671335265106100 TABLET in 1 BOTTLE (71335-2651-6) 100 tablet2025-06-03NoNoCurrent
71335-2651-77133526510725 TABLET in 1 BOTTLE (71335-2651-7) 25 tablet2025-06-03NoNoCurrent
71335-2651-871335265108120 TABLET in 1 BOTTLE (71335-2651-8) 120 tablet2025-06-03NoNoCurrent
71335-2651-97133526510928 TABLET in 1 BOTTLE (71335-2651-9) 28 tablet2025-06-03NoNoCurrent