Trazodone Hydrochloride

Product NDC
67046-1662
11-digit product format
670461662
Labeler code
67046
Product ID
67046-1662_4c4c97d0-fe68-18ea-e063-6294a90abaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA073137
Marketing category
ANDA
Marketing start
2026-03-05
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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 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
67046-1662-3Trazodone Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN4c4ca53e-9201-298c-e063-6294a90a72c61
856373trazodone hydrochloride 100 MG Oral TabletSCD4c4ca53e-9201-298c-e063-6294a90a72c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1662-36704616620330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1662-3) 2026-03-05NoNoHistorical