FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71205-505
11-digit product format
712050505
Labeler code
71205
Product ID
71205-505_facbef5f-e03e-471a-9075-0b4f7f02b2cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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
Rxcui856377

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
71205-505-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
71205-505-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
71205-505-90Trazodone Hydrochloride90 in 1 CARTONTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-505-60EA - Each71205-5052d66aa3a-3582-463d-b858-86d1db575d8512022-08-04
71205-505-90EA - Each71205-5058539adbe-e1a7-4cef-b537-256fa1152df012026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-505TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220622_2a1d0989-6ed5-4a2f-bd03-73d61eb40232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN2a1d0989-6ed5-4a2f-bd03-73d61eb402322
856377trazodone hydrochloride 50 MG Oral TabletSCD2a1d0989-6ed5-4a2f-bd03-73d61eb402322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-505-307120505053030 TABLET in 1 BOTTLE (71205-505-30) 30 tablet2020-11-160000-00-00NoNoCurrent
71205-505-607120505056060 TABLET in 1 BOTTLE (71205-505-60) 60 tablet2020-11-160000-00-00NoNoCurrent
71205-505-907120505059090 TABLET in 1 CARTON (71205-505-90) 90 tablet2020-11-160000-00-00NoNoCurrent