FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-7439
11-digit product format
500907439
Labeler code
50090
Product ID
50090-7439_81b9e7a1-dd24-41c0-95f5-5fe43546c412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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

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
50090-7439-2Trazodone Hydrochloride30 in 1 BOTTLETABLET301
50090-7439-4Trazodone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7439-2EA - Each50090-743945042672-a9da-4352-b74e-3072a7872f6512024-12-10
50090-7439-4EA - Each50090-743946199757-0bf5-4ecc-bdf7-c7f4f0b257ff12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7439TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241109_be0dc037-d30a-4f07-ab7c-1695637b3740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSNbe0dc037-d30a-4f07-ab7c-1695637b37401
856364trazodone hydrochloride 150 MG Oral TabletSCDbe0dc037-d30a-4f07-ab7c-1695637b37401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7439-25009074390230 TABLET in 1 BOTTLE (50090-7439-2) 30 tablet2024-11-06NoNoCurrent
50090-7439-45009074390490 TABLET in 1 BOTTLE (50090-7439-4) 90 tablet2024-11-06NoNoCurrent