TRAZODONE HYDROCHLORIDE

Product NDC
13107-081
11-digit product format
131070081
Labeler code
13107
Product ID
13107-081_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
150 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 HYDROCHLORIDE150 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
13107-081-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1009
13107-081-05TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5009
13107-081-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET309
13107-081-99TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-081-01EA - Each13107-0810848ef39-1af9-4f00-843c-123754059aa812021-12-08
13107-081-05EA - Each13107-081a1a6bb46-1dbe-4211-bbce-ba4bb9e0f42812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-081TRAZODONE 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
856364traZODone HCl 150 MG Oral TabletPSNa343910a-bf4c-4a41-b0ee-0e90e8355815101
856364trazodone hydrochloride 150 MG Oral TabletSCDa343910a-bf4c-4a41-b0ee-0e90e8355815101
856364traZODone HCl 150 MG Oral TabletPSN24b5eee4-4210-4b90-a695-11e6a5868988100
856364trazodone hydrochloride 150 MG Oral TabletSCD24b5eee4-4210-4b90-a695-11e6a5868988100
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
856364traZODone HCl 150 MG Oral TabletPSNf8fc1f03-cd9d-9fa9-e053-6294a90a86652
856364trazodone hydrochloride 150 MG Oral TabletSCDf8fc1f03-cd9d-9fa9-e053-6294a90a86652
856364traZODone HCl 150 MG Oral TabletPSN34986e81-da05-46c1-8dd6-1dd7a8d1a44f1
856364trazodone hydrochloride 150 MG Oral TabletSCD34986e81-da05-46c1-8dd6-1dd7a8d1a44f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-081-0113107008101100 TABLET in 1 BOTTLE (13107-081-01) 100 tablet2015-09-150000-00-00NoNoCurrent
13107-081-0513107008105500 TABLET in 1 BOTTLE (13107-081-05) 500 tablet2015-09-150000-00-00NoNoCurrent
13107-081-201310700812020 TABLET in 1 BOTTLE (13107-081-20) 20 tablet2015-09-150000-00-00NoNoCurrent
13107-081-301310700813030 TABLET in 1 BOTTLE (13107-081-30) 30 tablet2015-09-15NoNoHistorical
13107-081-99131070081991000 TABLET in 1 BOTTLE (13107-081-99) 1000 tablet2015-09-150000-00-00NoNoCurrent