FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
13107-082
11-digit product format
131070082
Labeler code
13107
Product ID
13107-082_db4e6aff-149f-4f16-9512-e81e0c3e6900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAZODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA204852
Marketing category
ANDA
Marketing start
2015-09-15
Substance
TRAZODONE HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 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
13107-082-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1009
13107-082-05TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5009
13107-082-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET309
13107-082-99TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-082-01EA - Each13107-082210a4664-b9dc-4030-b2a9-c8eabef81e7712021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-082TRAZODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]9Current NDC, Legacy NDC, 4 package rows20250412_295e92a9-bcb0-4d53-ba62-e30020e9834b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856369traZODone HCl 300 MG Oral TabletPSN1514b3b0-7742-4247-b9fd-ea14849d3fdd101
856369trazodone hydrochloride 300 MG Oral TabletSCD1514b3b0-7742-4247-b9fd-ea14849d3fdd101
856369traZODone HCl 300 MG Oral TabletPSN470a98a2-4e68-4c98-b3c8-e5eba4e55cdc100
856369trazodone hydrochloride 300 MG Oral TabletSCD470a98a2-4e68-4c98-b3c8-e5eba4e55cdc100
856373traZODone HCl 100 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856364traZODone HCl 150 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856369traZODone HCl 300 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856377traZODone HCl 50 MG Oral TabletPSN295e92a9-bcb0-4d53-ba62-e30020e9834b9
856373trazodone hydrochloride 100 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856364trazodone hydrochloride 150 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856369trazodone hydrochloride 300 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9
856377trazodone hydrochloride 50 MG Oral TabletSCD295e92a9-bcb0-4d53-ba62-e30020e9834b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-082-0113107008201100 TABLET in 1 BOTTLE (13107-082-01) 100 tablet2015-09-150000-00-00NoNoCurrent
13107-082-0513107008205500 TABLET in 1 BOTTLE (13107-082-05) 500 tablet2015-09-150000-00-00NoNoCurrent
13107-082-301310700823030 TABLET in 1 BOTTLE (13107-082-30) 30 tablet2015-09-15NoNoHistorical
13107-082-99131070082991000 TABLET in 1 BOTTLE (13107-082-99) 1000 tablet2015-09-15NoNoHistorical