FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70518-3479
11-digit product format
705183479
Labeler code
70518
Product ID
70518-3479_4f1c750b-ca39-e665-e063-6294a90a2db7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2022-08-16
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856364

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
70518-3479-0Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3011
70518-3479-1Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET3011
70518-3479-2Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3479TRAZODONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 3 package rows20250523_1f74b23d-f2eb-4c18-a583-d608b7713694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN1f74b23d-f2eb-4c18-a583-d608b771369411
856364trazodone hydrochloride 150 MG Oral TabletSCD1f74b23d-f2eb-4c18-a583-d608b771369411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3479-07051834790030 TABLET in 1 BOTTLE, PLASTIC (70518-3479-0) 30 tablet2022-08-160000-00-00NoNoCurrent
70518-3479-17051834790130 TABLET in 1 BLISTER PACK (70518-3479-1) 30 tablet2023-05-24NoNoHistorical
70518-3479-27051834790290 in 1 BOTTLE, PLASTICHistorical