FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
0904-6868
11-digit product format
009046868
Labeler code
0904
Product ID
0904-6868_1bfc986d-82a1-4503-8eea-7ebf3186d09d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
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
Rxcui856364, 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
0904-6868-61Trazodone Hydrochloride100 in 1 CARTONTABLET1009
0904-6868-61Trazodone Hydrochloride1 in 1 BLISTER PACKTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6868-61EA - Each0904-68681d197cfd-c67d-4233-ba00-a8cccf167f1b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6868TRAZODONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20250214_8eb85c26-a6cb-4a10-a990-ccc0b20aff08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856364traZODone HCl 150 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377traZODone HCl 50 MG Oral TabletPSN8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856373trazodone hydrochloride 100 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856364trazodone hydrochloride 150 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856377trazodone hydrochloride 50 MG Oral TabletSCD8eb85c26-a6cb-4a10-a990-ccc0b20aff089
856373traZODone HCl 100 MG Oral TabletPSN9265f4f6-df24-4495-9dbf-e3fcfa4c864d8
856377traZODone HCl 50 MG Oral TabletPSN9265f4f6-df24-4495-9dbf-e3fcfa4c864d8
856373trazodone hydrochloride 100 MG Oral TabletSCD9265f4f6-df24-4495-9dbf-e3fcfa4c864d8
856377trazodone hydrochloride 50 MG Oral TabletSCD9265f4f6-df24-4495-9dbf-e3fcfa4c864d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6868-6100904686861100 BLISTER PACK in 1 CARTON (0904-6868-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2017-12-110000-00-00NoNoCurrent