FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
80425-0326
11-digit product format
804250326
Labeler code
80425
Product ID
80425-0326_46417fb5-59f0-15d4-e063-6394a90a10b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA202180
Marketing category
ANDA
Marketing start
2023-04-17
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
80425-0326-1Trazodone Hydrochloride30 in 1 BOTTLETABLET303
80425-0326-2Trazodone Hydrochloride60 in 1 BOTTLETABLET603
80425-0326-3Trazodone Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0326-1EA - Each80425-03269a841112-ce15-4e0c-a7a9-1c8f805749ab12023-06-06
80425-0326-2EA - Each80425-032655dbfb75-b9bf-4aec-bc8e-5fc5cbafcd3812023-06-06
80425-0326-3EA - Each80425-03267f184007-4b0d-4d99-8dd2-ded93bebf4c712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0326TRAZODONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f98b1e8f-9c66-3e9c-e053-6294a90ab057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNf98b1e8f-9c66-3e9c-e053-6294a90ab0573
856377trazodone hydrochloride 50 MG Oral TabletSCDf98b1e8f-9c66-3e9c-e053-6294a90ab0573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0326-18042503260130 TABLET in 1 BOTTLE (80425-0326-1) 30 tablet2023-04-17NoNoHistorical
80425-0326-28042503260260 TABLET in 1 BOTTLE (80425-0326-2) 60 tablet2023-04-17NoNoHistorical
80425-0326-38042503260390 TABLET in 1 BOTTLE (80425-0326-3) 90 tablet2023-04-17NoNoHistorical