FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-5218
11-digit product format
500905218
Labeler code
50090
Product ID
50090-5218_b80aed44-291f-4708-8f9e-6ccf9d761a33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856377

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
50090-5218-0Trazodone Hydrochloride30 in 1 BOTTLETABLET3011
50090-5218-1Trazodone Hydrochloride100 in 1 BOTTLETABLET10011
50090-5218-6Trazodone Hydrochloride60 in 1 BOTTLETABLET6011
50090-5218-8Trazodone Hydrochloride45 in 1 BOTTLETABLET4511
50090-5218-9Trazodone Hydrochloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5218-0EA - Each50090-52183d3d40c9-3ac7-402a-b284-36e7a176de3e12021-08-05
50090-5218-1EA - Each50090-52183cdfc649-2b26-4a8d-aadf-626f3024442f12022-12-07
50090-5218-6EA - Each50090-52188b35fd8e-1666-4e6d-8501-6066dc06f13512022-12-07
50090-5218-8EA - Each50090-52184f0cf292-1549-42f7-930d-6da80cd7ab8e12022-12-07
50090-5218-9EA - Each50090-5218ba00b01d-48a1-40de-a6e3-8c86b0accc8a12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5218TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 5 package rows20231217_3df90104-ef2c-4a82-b007-9843c43969ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN3df90104-ef2c-4a82-b007-9843c43969ae11
856377trazodone hydrochloride 50 MG Oral TabletSCD3df90104-ef2c-4a82-b007-9843c43969ae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5218-05009052180030 TABLET in 1 BOTTLE (50090-5218-0) 30 tablet2020-10-060000-00-00NoNoCurrent
50090-5218-150090521801100 TABLET in 1 BOTTLE (50090-5218-1) 100 tablet2020-10-060000-00-00NoNoCurrent
50090-5218-65009052180660 TABLET in 1 BOTTLE (50090-5218-6) 60 tablet2020-10-060000-00-00NoNoCurrent
50090-5218-85009052180845 TABLET in 1 BOTTLE (50090-5218-8) 45 tablet2022-10-270000-00-00NoNoCurrent
50090-5218-95009052180990 TABLET in 1 BOTTLE (50090-5218-9) 90 tablet2020-10-060000-00-00NoNoCurrent