FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-7943
11-digit product format
500907943
Labeler code
50090
Product ID
50090-7943_4e59b4ff-439c-43fa-ad8c-f83983f8e4f8
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
2026-01-22
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
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
50090-7943-0Trazodone Hydrochloride30 in 1 BOTTLETABLET304
50090-7943-1Trazodone Hydrochloride100 in 1 BOTTLETABLET1004
50090-7943-6Trazodone Hydrochloride60 in 1 BOTTLETABLET604
50090-7943-8Trazodone Hydrochloride45 in 1 BOTTLETABLET454
50090-7943-9Trazodone Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7943-0EA - Each50090-79435d65b339-fd6b-41ee-9b7d-c4b590e929df12026-05-22
50090-7943-1EA - Each50090-794379a91b43-eaf9-4491-a1aa-4cef9c0e84bf12026-05-22
50090-7943-6EA - Each50090-79433536c018-7817-4068-8c77-17ed22bc5b4612026-05-22
50090-7943-8EA - Each50090-79439dd942c2-3b2e-46d6-a9ce-a0f463d50da412026-05-22
50090-7943-9EA - Each50090-79438e91bb3f-1435-4154-a2d7-208c2c98f95d12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN51e1ef06-d2c8-46db-a2b4-f20d4cc1abf34
856377trazodone hydrochloride 50 MG Oral TabletSCD51e1ef06-d2c8-46db-a2b4-f20d4cc1abf34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7943-05009079430030 TABLET in 1 BOTTLE (50090-7943-0) 30 tablet2026-03-30NoNoHistorical
50090-7943-150090794301100 TABLET in 1 BOTTLE (50090-7943-1) 100 tablet2026-03-30NoNoHistorical
50090-7943-65009079430660 TABLET in 1 BOTTLE (50090-7943-6) 60 tablet2026-03-30NoNoHistorical
50090-7943-85009079430845 TABLET in 1 BOTTLE (50090-7943-8) 45 tablet2026-03-30NoNoHistorical
50090-7943-95009079430990 TABLET in 1 BOTTLE (50090-7943-9) 90 tablet2026-03-30NoNoHistorical