FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
60687-454
11-digit product format
606870454
Labeler code
60687
Product ID
60687-454_4121a0e8-9204-0334-e063-6294a90aa532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205253
Marketing category
ANDA
Marketing start
2019-03-15
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, 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
60687-454-01Trazodone Hydrochloride100 in 1 CARTONTABLET1006
60687-454-11Trazodone Hydrochloride1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-454-01EA - Each60687-4541f3d44f4-e091-4189-904e-1fdfa969724d12019-04-11
60687-454-11EA - Each60687-454c2f5629f-9c7e-4584-995e-3ab8779f931c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-454TRAZODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241030_094ca37b-3ae2-4889-9536-e7e5f20e3105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856364traZODone HCl 150 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856377traZODone HCl 50 MG Oral TabletPSN094ca37b-3ae2-4889-9536-e7e5f20e31056
856373trazodone hydrochloride 100 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056
856364trazodone hydrochloride 150 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056
856377trazodone hydrochloride 50 MG Oral TabletSCD094ca37b-3ae2-4889-9536-e7e5f20e31056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-454-0160687045401100 BLISTER PACK in 1 CARTON (60687-454-01) / 1 TABLET in 1 BLISTER PACK (60687-454-11) 100 blister pack2019-03-150000-00-00NoNoCurrent
60687-454-11606870454111 in 1 BLISTER PACKHistorical