Trazodone Hydrochloride

Product NDC
71610-530
11-digit product format
716100530
Labeler code
71610
Product ID
71610-530_3ab5bd42-a909-30d0-e063-6394a90aee04
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
2020-11-06
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
71610-530-30Trazodone Hydrochloride30 in 1 BOTTLETABLET303
71610-530-45Trazodone Hydrochloride45 in 1 BOTTLETABLET453
71610-530-53Trazodone Hydrochloride60 in 1 BOTTLETABLET603
71610-530-60Trazodone Hydrochloride90 in 1 BOTTLETABLET903
71610-530-80Trazodone Hydrochloride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-530-30EA - Each71610-5309d0c1e3e-3d86-4828-97ab-70c8d75eaad912021-05-05
71610-530-53EA - Each71610-530b4d01f5b-4ded-49f7-8710-809ec20b142c12021-05-05
71610-530-60EA - Each71610-530a92a5dba-67d7-4a90-acf4-40b5dbbe0b1c12021-07-15
71610-530-80EA - Each71610-53011da7734-a66d-4995-a81b-f5a59da177ed12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-530TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20210602_5ab590d8-225f-43f4-bb68-1f2c86f9a886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856377traZODone HCl 50 MG Oral TabletPSN5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856373trazodone hydrochloride 100 MG Oral TabletSCD5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856377trazodone hydrochloride 50 MG Oral TabletSCD5ab590d8-225f-43f4-bb68-1f2c86f9a8863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-530-307161005303030 TABLET in 1 BOTTLE (71610-530-30) 30 tablet2021-03-090000-00-00NoNoCurrent
71610-530-457161005304545 TABLET in 1 BOTTLE (71610-530-45) 45 tablet2025-07-24NoNoHistorical
71610-530-537161005305360 TABLET in 1 BOTTLE (71610-530-53) 60 tablet2021-03-090000-00-00NoNoCurrent
71610-530-607161005306090 TABLET in 1 BOTTLE (71610-530-60) 90 tablet2021-04-130000-00-00NoNoCurrent
71610-530-8071610053080180 TABLET in 1 BOTTLE (71610-530-80) 180 tablet2021-03-090000-00-00NoNoCurrent