Trazodone Hydrochloride

Product NDC
16729-300
11-digit product format
167290300
Labeler code
16729
Product ID
16729-300_4629674c-30f5-3709-e063-6394a90a3dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA206923
Marketing category
ANDA
Marketing start
2018-10-05
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
16729-300-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10012
16729-300-16Trazodone Hydrochloride500 in 1 BOTTLETABLET50012
16729-300-17Trazodone Hydrochloride1000 in 1 BOTTLETABLET100012
16729-300-43Trazodone Hydrochloride10 in 1 CARTONTABLET1012
16729-300-44Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-300-01EA - Each16729-300d4652219-d489-4ef0-a541-0b71a304258d12018-11-06
16729-300-17EA - Each16729-300b50c6150-68ed-4fcf-bd73-8b067f6ee9e412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-300TRAZODONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 5 package rows20240221_ed3039d8-3d27-4b71-a4b0-812943c9457f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856364traZODone HCl 150 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856369traZODone HCl 300 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856377traZODone HCl 50 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856373trazodone hydrochloride 100 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856364trazodone hydrochloride 150 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856369trazodone hydrochloride 300 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856377trazodone hydrochloride 50 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856373traZODone HCl 100 MG Oral TabletPSNa90caa68-b28e-425f-b77c-7b566ac17dc22
856373trazodone hydrochloride 100 MG Oral TabletSCDa90caa68-b28e-425f-b77c-7b566ac17dc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-300-0116729030001100 TABLET in 1 BOTTLE (16729-300-01) 100 tablet2018-10-050000-00-00NoNoCurrent
16729-300-1616729030016500 in 1 BOTTLEHistorical
16729-300-17167290300171000 TABLET in 1 BOTTLE (16729-300-17) 1000 tablet2018-10-090000-00-00NoNoCurrent
16729-300-431672903004310 in 1 CARTONHistorical
16729-300-441672903004410 in 1 BLISTER PACKHistorical