FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50111-450
11-digit product format
501110450
Labeler code
50111
Product ID
50111-450_3313a8d0-eb39-47a4-b476-0973aad30e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071525
Marketing category
ANDA
Marketing start
2020-03-11
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, 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
50111-450-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10030
50111-450-02Trazodone Hydrochloride500 in 1 BOTTLETABLET50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-450-01EA - Each50111-450887cd145-c278-4b6e-958c-44345f23e19012020-04-20
50111-450-02EA - Each50111-45032959d4c-cb4b-4532-b0c2-a67db5085a7512020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [PLIVA INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-450TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]28Current NDC, Legacy NDC, 2 package rows20230210_4006d439-e2de-4590-82e9-fc9d56e3ec1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856364traZODone HCl 150 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856377traZODone HCl 50 MG Oral TabletPSN4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856373trazodone hydrochloride 100 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856364trazodone hydrochloride 150 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856377trazodone hydrochloride 50 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856364traZODone HCl 150 MG Oral TabletPSN9b022ae9-dd52-43ae-804b-ddf8e7cfd53024
856364trazodone hydrochloride 150 MG Oral TabletSCD9b022ae9-dd52-43ae-804b-ddf8e7cfd53024
856364traZODone HCl 150 MG Oral TabletPSN310c4b81-d2cf-4014-873d-e71d036105de12
856377traZODone HCl 50 MG Oral TabletPSN310c4b81-d2cf-4014-873d-e71d036105de12
856364trazodone hydrochloride 150 MG Oral TabletSCD310c4b81-d2cf-4014-873d-e71d036105de12
856377trazodone hydrochloride 50 MG Oral TabletSCD310c4b81-d2cf-4014-873d-e71d036105de12
856364traZODone HCl 150 MG Oral TabletPSNa382ac4d-9ab9-796a-e053-2a95a90a2c264
856364trazodone hydrochloride 150 MG Oral TabletSCDa382ac4d-9ab9-796a-e053-2a95a90a2c264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-450-0150111045001100 TABLET in 1 BOTTLE (50111-450-01) 100 tablet2020-03-110000-00-00NoNoCurrent
50111-450-0250111045002500 TABLET in 1 BOTTLE (50111-450-02) 500 tablet2020-03-110000-00-00NoNoCurrent
50111-450-885011104508823500 TABLET in 1 CONTAINER (50111-450-88)23500 tablet20-JUN-25Current