FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71205-568
11-digit product format
712050568
Labeler code
71205
Product ID
71205-568_6bf8f35d-c071-44d1-9779-7aa63ede683d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
71205-568-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
71205-568-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
71205-568-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-568-30EA - Each71205-5688f8e1128-19f1-463c-bbab-91c4395caf4b12021-10-08
71205-568-90EA - Each71205-5687da9674c-02b2-46fa-965f-679d4d3122c612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-568TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220511_f6c3fb84-5b68-4675-a853-fe49bfbf3f9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2
856377trazodone hydrochloride 50 MG Oral TabletSCDf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-568-307120505683030 TABLET in 1 BOTTLE (71205-568-30) 30 tablet2021-05-170000-00-00NoNoCurrent
71205-568-607120505686060 TABLET in 1 BOTTLE (71205-568-60) 60 tablet2021-05-170000-00-00NoNoCurrent
71205-568-907120505689090 TABLET in 1 BOTTLE (71205-568-90) 90 tablet2021-05-170000-00-00NoNoCurrent