Trazodone Hydrochloride

Product NDC
70518-4363
11-digit product format
705184363
Labeler code
70518
Product ID
70518-4363_39a96071-618e-9b79-e063-6394a90a03ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073137
Marketing category
ANDA
Marketing start
2025-06-18
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
70518-4363-0Trazodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
70518-4363-1Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNfa7afa93-b98c-4dc7-bbb8-ab6a058427b92
856377trazodone hydrochloride 50 MG Oral TabletSCDfa7afa93-b98c-4dc7-bbb8-ab6a058427b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4363-07051843630060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4363-0) 2025-06-18NoNoHistorical
70518-4363-17051843630130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4363-1) 2025-07-11NoNoHistorical