FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
13107-080
11-digit product format
131070080
Labeler code
13107
Product ID
13107-080_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
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
13107-080-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1009
13107-080-05TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5009
13107-080-30TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET309
13107-080-99TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-080-01EA - Each13107-080c01bd5bb-0e25-498f-81c8-83eab987c17c12021-12-08
13107-080-05EA - Each13107-080473060ab-1875-4e21-871b-d881014164a812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-080TRAZODONE 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
856373traZODone HCl 100 MG Oral TabletPSN4370fe5c-1c40-499b-abb5-bca0a39834c6100
856373traZODone HCl 100 MG Oral TabletPSN7baa8eef-3a5c-43b3-a5fe-0c449aacda2e100
856373traZODone HCl 100 MG Oral TabletPSNb57daea8-5a39-41c1-842e-b1d15115e36f100
856373traZODone HCl 100 MG Oral TabletPSNfdd35113-5f51-49c5-a29c-ffdddd28ef38100
856373trazodone hydrochloride 100 MG Oral TabletSCD4370fe5c-1c40-499b-abb5-bca0a39834c6100
856373trazodone hydrochloride 100 MG Oral TabletSCD7baa8eef-3a5c-43b3-a5fe-0c449aacda2e100
856373trazodone hydrochloride 100 MG Oral TabletSCDb57daea8-5a39-41c1-842e-b1d15115e36f100
856373trazodone hydrochloride 100 MG Oral TabletSCDfdd35113-5f51-49c5-a29c-ffdddd28ef38100
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
856373traZODone HCl 100 MG Oral TabletPSNfec78f5d-2567-44d3-9f04-1a69133570197
856373trazodone hydrochloride 100 MG Oral TabletSCDfec78f5d-2567-44d3-9f04-1a69133570197
856373traZODone HCl 100 MG Oral TabletPSNf89ad429-0056-e4d6-e053-6294a90a7ab13
856373trazodone hydrochloride 100 MG Oral TabletSCDf89ad429-0056-e4d6-e053-6294a90a7ab13
856373traZODone HCl 100 MG Oral TabletPSNdfd2698d-b7a3-49e0-aa2f-1af0ca894b351
856373trazodone hydrochloride 100 MG Oral TabletSCDdfd2698d-b7a3-49e0-aa2f-1af0ca894b351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-080-0113107008001100 TABLET in 1 BOTTLE (13107-080-01) 100 tablet2015-09-150000-00-00NoNoCurrent
13107-080-0513107008005500 TABLET in 1 BOTTLE (13107-080-05) 500 tablet2015-09-150000-00-00NoNoCurrent
13107-080-301310700803030 TABLET in 1 BOTTLE (13107-080-30) 30 tablet2015-09-150000-00-00NoNoCurrent
13107-080-99131070080991000 TABLET in 1 BOTTLE (13107-080-99) 1000 tablet2015-09-150000-00-00NoNoCurrent