FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71610-529
11-digit product format
716100529
Labeler code
71610
Product ID
71610-529_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
ANDA071523
Marketing category
ANDA
Marketing start
2020-10-01
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
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
71610-529-15Trazodone Hydrochloride15 in 1 BOTTLETABLET154
71610-529-30Trazodone Hydrochloride30 in 1 BOTTLETABLET304
71610-529-45Trazodone Hydrochloride45 in 1 BOTTLETABLET454
71610-529-53Trazodone Hydrochloride60 in 1 BOTTLETABLET604
71610-529-60Trazodone Hydrochloride90 in 1 BOTTLETABLET904
71610-529-70Trazodone Hydrochloride120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-529-15EA - Each71610-5292e5cd802-e360-4de9-98b5-ef750149ec8712024-09-09
71610-529-30EA - Each71610-52930a35d24-72f8-442c-b840-5f2becb20a8e12021-05-05
71610-529-45EA - Each71610-529e53a1c64-5ad0-4379-8cee-c7fee02448b112021-09-07
71610-529-53EA - Each71610-529a54bccbc-e6bc-476e-b507-0592befb6ff612021-05-05
71610-529-60EA - Each71610-529f86c0a92-c456-448e-ac31-53c06dc7a25d12021-05-05
71610-529-70EA - Each71610-52978ec4999-97dc-4ea5-a8c6-7eed8ca79d4912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-529TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 6 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
71610-529-157161005291515 TABLET in 1 BOTTLE (71610-529-15) 15 tablet2024-07-16NoNoHistorical
71610-529-307161005293030 TABLET in 1 BOTTLE (71610-529-30) 30 tablet2021-03-040000-00-00NoNoCurrent
71610-529-457161005294545 TABLET in 1 BOTTLE (71610-529-45) 45 tablet2021-08-110000-00-00NoNoCurrent
71610-529-537161005295360 TABLET in 1 BOTTLE (71610-529-53) 60 tablet2021-03-040000-00-00NoNoCurrent
71610-529-607161005296090 TABLET in 1 BOTTLE (71610-529-60) 90 tablet2021-03-040000-00-00NoNoCurrent
71610-529-7071610052970120 TABLET in 1 BOTTLE (71610-529-70) 120 tablet2024-07-16NoNoHistorical