FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
64980-672
11-digit product format
649800672
Labeler code
64980
Product ID
64980-672_ab9a16ff-7bca-4445-b6e5-5122e097995c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trazodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217740
Marketing category
ANDA
Marketing start
2025-01-29
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
Rxcui856364, 856369, 856373, 856377

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
64980-672-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
64980-672-10TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10002
64980-672-50TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-672-01EA - Each64980-672bf919756-60e7-4593-a820-b4892e69460112025-03-04
64980-672-10EA - Each64980-67293113089-74e1-4910-b658-fe02206769d412025-11-13
64980-672-50EA - Each64980-67257a8a856-20a3-468c-845d-63492344a97012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-672TRAZODONE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20250515_ef26e4f0-f31f-4efa-9938-28c886cf3d1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856364traZODone HCl 150 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856369traZODone HCl 300 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856377traZODone HCl 50 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856373trazodone hydrochloride 100 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856364trazodone hydrochloride 150 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856369trazodone hydrochloride 300 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856377trazodone hydrochloride 50 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-672-0164980067201100 TABLET in 1 BOTTLE (64980-672-01) 100 tablet2025-01-29NoNoHistorical
64980-672-10649800672101000 TABLET in 1 BOTTLE (64980-672-10) 1000 tablet2025-04-11NoNoHistorical
64980-672-5064980067250500 TABLET in 1 BOTTLE (64980-672-50) 500 tablet2025-01-29NoNoHistorical