FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
64980-673
11-digit product format
649800673
Labeler code
64980
Product ID
64980-673_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
100 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 HYDROCHLORIDE100 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
64980-673-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
64980-673-10TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10002
64980-673-50TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-673-01EA - Each64980-673ee7fd90e-511d-4abe-9231-743dc176326512025-03-04
64980-673-10EA - Each64980-67338359268-2bb2-4475-8df7-bdf9e063a30412025-11-13
64980-673-50EA - Each64980-673882ac71f-83f3-4075-ac19-884919b8617212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-673TRAZODONE 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
64980-673-0164980067301100 TABLET in 1 BOTTLE (64980-673-01) 100 tablet2025-01-29NoNoHistorical
64980-673-10649800673101000 TABLET in 1 BOTTLE (64980-673-10) 1000 tablet2025-04-11NoNoHistorical
64980-673-5064980067350500 TABLET in 1 BOTTLE (64980-673-50) 500 tablet2025-01-29NoNoHistorical