FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71610-525
11-digit product format
716100525
Labeler code
71610
Product ID
71610-525_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
ANDA071523
Marketing category
ANDA
Marketing start
2020-11-06
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
71610-525-15Trazodone Hydrochloride15 in 1 BOTTLETABLET153
71610-525-30Trazodone Hydrochloride30 in 1 BOTTLETABLET303
71610-525-45Trazodone Hydrochloride45 in 1 BOTTLETABLET453
71610-525-53Trazodone Hydrochloride60 in 1 BOTTLETABLET603
71610-525-60Trazodone Hydrochloride90 in 1 BOTTLETABLET903
71610-525-70Trazodone Hydrochloride120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-525-15EA - Each71610-525e1ec88be-dada-4455-a73c-8846019abae912021-04-08
71610-525-30EA - Each71610-5252e316c6d-560b-4b05-9e55-1456eb54624512021-04-08
71610-525-45EA - Each71610-525186695e9-0b08-478a-ba1c-1980bb176a5812021-04-08
71610-525-53EA - Each71610-525e9b5b5d8-17dd-4195-a17b-1f99962d98a612021-04-08
71610-525-60EA - Each71610-52544048e1f-a5b3-43f4-bc35-f2c5f716d5fb12021-09-07
71610-525-70EA - Each71610-525b2f7da16-471b-47bd-8043-346eb8cc506612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-525TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 6 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
71610-525-157161005251515 TABLET in 1 BOTTLE (71610-525-15) 15 tablet2021-02-080000-00-00NoNoCurrent
71610-525-307161005253030 TABLET in 1 BOTTLE (71610-525-30) 30 tablet2021-02-080000-00-00NoNoCurrent
71610-525-457161005254545 TABLET in 1 BOTTLE (71610-525-45) 45 tablet2021-02-080000-00-00NoNoCurrent
71610-525-537161005255360 TABLET in 1 BOTTLE (71610-525-53) 60 tablet2021-02-080000-00-00NoNoCurrent
71610-525-607161005256090 TABLET in 1 BOTTLE (71610-525-60) 90 tablet2021-04-070000-00-00NoNoCurrent
71610-525-7071610052570120 TABLET in 1 BOTTLE (71610-525-70) 120 tablet2021-02-080000-00-00NoNoCurrent