FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71205-630
11-digit product format
712050630
Labeler code
71205
Product ID
71205-630_59aa7e27-52ed-41c9-8408-0b3b481debfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206923
Marketing category
ANDA
Marketing start
2018-10-05
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

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
71205-630-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
71205-630-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
71205-630-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-630-30EA - Each71205-63038c28e5d-7ba7-4649-960d-eb4fea6fa1fe12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-630TRAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220816_a90caa68-b28e-425f-b77c-7b566ac17dc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNa90caa68-b28e-425f-b77c-7b566ac17dc22
856373trazodone hydrochloride 100 MG Oral TabletSCDa90caa68-b28e-425f-b77c-7b566ac17dc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-630-307120506303030 TABLET in 1 BOTTLE (71205-630-30) 30 tablet2022-01-070000-00-00NoNoCurrent
71205-630-607120506306060 TABLET in 1 BOTTLE (71205-630-60) 60 tablet2022-01-070000-00-00NoNoCurrent
71205-630-907120506309090 TABLET in 1 BOTTLE (71205-630-90) 90 tablet2022-01-070000-00-00NoNoCurrent