TRAZODONE HYDROCHLORIDE

Product NDC
70518-4441
11-digit product format
705184441
Labeler code
70518
Product ID
70518-4441_3c5575b9-f803-0046-e063-6294a90af2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204852
Marketing category
ANDA
Marketing start
2025-08-14
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
70518-4441-0TRAZODONE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNb0a79ee7-3140-48cb-b734-244a4420e32c1
856377trazodone hydrochloride 50 MG Oral TabletSCDb0a79ee7-3140-48cb-b734-244a4420e32c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4441-07051844410030 TABLET in 1 BLISTER PACK (70518-4441-0) 30 tablet2025-08-14NoNoHistorical