FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
80425-0298
11-digit product format
804250298
Labeler code
80425
Product ID
80425-0298_47a7b983-c60b-a994-e063-6394a90a4cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA204852
Marketing category
ANDA
Marketing start
2023-04-05
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

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
80425-0298-1Trazodone Hydrochloride30 in 1 BOTTLETABLET303
80425-0298-2Trazodone Hydrochloride60 in 1 BOTTLETABLET603
80425-0298-3Trazodone Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0298-1EA - Each80425-029838b10f69-a39d-4967-9975-f1d50b913d9412023-06-06
80425-0298-2EA - Each80425-0298f46c9a3e-d6ec-4f67-9529-44d590d7324c12023-06-06
80425-0298-3EA - Each80425-02983d3e9e0a-deb0-4aaf-8f6e-72009dfdfcdb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0298TRAZODONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f89ad429-0056-e4d6-e053-6294a90a7ab1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNf89ad429-0056-e4d6-e053-6294a90a7ab13
856373trazodone hydrochloride 100 MG Oral TabletSCDf89ad429-0056-e4d6-e053-6294a90a7ab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0298-18042502980130 TABLET in 1 BOTTLE (80425-0298-1) 30 tablet2023-04-05NoNoHistorical
80425-0298-28042502980260 TABLET in 1 BOTTLE (80425-0298-2) 60 tablet2023-04-05NoNoHistorical
80425-0298-38042502980390 TABLET in 1 BOTTLE (80425-0298-3) 90 tablet2023-04-05NoNoHistorical