FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70010-231
11-digit product format
700100231
Labeler code
70010
Product ID
70010-231_5096700d-3b93-70a3-e063-6294a90ad1d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA218988
Marketing category
ANDA
Marketing start
2024-08-09
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 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
70010-231-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1004
70010-231-03Trazodone Hydrochloride30 in 1 BOTTLETABLET304
70010-231-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5004
70010-231-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-231-01EA - Each70010-2311b6e1422-cde2-4bc9-a20f-e0d6266e400812024-09-09
70010-231-05EA - Each70010-231028c9590-9774-49eb-a441-8d5c29304fb812024-09-09
70010-231-10EA - Each70010-231a228ec12-f4aa-4870-8d02-09bbc90dce3d12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-231TRAZODONE HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250326_5bc5f266-6c0e-4b9a-b6e0-ea694928b948.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856364traZODone HCl 150 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856369traZODone HCl 300 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377traZODone HCl 50 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856373trazodone hydrochloride 100 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856364trazodone hydrochloride 150 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856369trazodone hydrochloride 300 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377trazodone hydrochloride 50 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377traZODone HCl 50 MG Oral TabletPSN2c7dca0c-8313-7d85-e063-6294a90aca612
856377trazodone hydrochloride 50 MG Oral TabletSCD2c7dca0c-8313-7d85-e063-6294a90aca612
856373traZODone HCl 100 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856377traZODone HCl 50 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856373trazodone hydrochloride 100 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1
856377trazodone hydrochloride 50 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-231-0170010023101100 TABLET in 1 BOTTLE (70010-231-01) 100 tablet2024-08-09NoNoCurrent
70010-231-037001002310330 TABLET in 1 BOTTLE (70010-231-03) 30 tablet2024-08-09NoNoCurrent
70010-231-0570010023105500 TABLET in 1 BOTTLE (70010-231-05) 500 tablet2024-08-09NoNoCurrent
70010-231-10700100231101000 TABLET in 1 BOTTLE (70010-231-10) 1000 tablet2024-10-01NoNoCurrent