FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71610-537
11-digit product format
716100537
Labeler code
71610
Product ID
71610-537_3eee48e1-08c4-2e12-e063-6394a90a2b13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071524
Marketing category
ANDA
Marketing start
2020-10-08
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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 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
71610-537-30Trazodone Hydrochloride30 in 1 BOTTLETABLET304
71610-537-45Trazodone Hydrochloride45 in 1 BOTTLETABLET454
71610-537-53Trazodone Hydrochloride60 in 1 BOTTLETABLET604
71610-537-60Trazodone Hydrochloride90 in 1 BOTTLETABLET904
71610-537-80Trazodone Hydrochloride180 in 1 BOTTLETABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-537-30EA - Each71610-53702b09201-6a7f-419c-b4d9-38132e19d96312021-05-05
71610-537-45EA - Each71610-537c9638617-9edf-467e-bc99-fc505ca5b95a12025-11-13
71610-537-53EA - Each71610-537c8fa7f7b-1dd3-4bcf-b2ae-cf207ee14f7712021-05-05
71610-537-60EA - Each71610-537422aefc4-2e94-4d4e-9e79-fbcdb29f650f12021-05-05
71610-537-80EA - Each71610-537f842178f-f108-4d85-86e2-9cfec88f0f9712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-537TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20240725_d42fd0c8-3673-4f18-a6c0-cd276bbf9fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377traZODone HCl 50 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856373trazodone hydrochloride 100 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377trazodone hydrochloride 50 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-537-307161005373030 TABLET in 1 BOTTLE (71610-537-30) 30 tablet2021-03-220000-00-00NoNoCurrent
71610-537-457161005374545 TABLET in 1 BOTTLE (71610-537-45) 45 tablet2025-09-15NoNoHistorical
71610-537-537161005375360 TABLET in 1 BOTTLE (71610-537-53) 60 tablet2021-03-220000-00-00NoNoCurrent
71610-537-607161005376090 TABLET in 1 BOTTLE (71610-537-60) 90 tablet2021-03-220000-00-00NoNoCurrent
71610-537-8071610053780180 TABLET in 1 BOTTLE (71610-537-80) 180 tablet2021-03-220000-00-00NoNoCurrent