Trazodone Hydrochloride

Product NDC
72789-424
11-digit product format
727890424
Labeler code
72789
Product ID
72789-424_4bc0edf7-fdf9-d8ab-e063-6394a90a8886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA071524
Marketing category
ANDA
Marketing start
2020-10-08
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
72789-424-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3032
72789-424-90Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-424TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]30Current NDC, 2 package rows20240814_b617348c-cb19-45df-b313-4ea6af6f1dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNb617348c-cb19-45df-b313-4ea6af6f1dda32
856373trazodone hydrochloride 100 MG Oral TabletSCDb617348c-cb19-45df-b313-4ea6af6f1dda32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-424-307278904243030 TABLET in 1 BOTTLE, PLASTIC (72789-424-30) 30 tablet2024-08-06NoNoCurrent
72789-424-907278904249090 TABLET in 1 BOTTLE, PLASTIC (72789-424-90) 90 tablet2024-08-12NoNoCurrent