FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50111-561
11-digit product format
501110561
Labeler code
50111
Product ID
50111-561_3313a8d0-eb39-47a4-b476-0973aad30e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071524
Marketing category
ANDA
Marketing start
2020-10-08
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
50111-561-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10030
50111-561-02Trazodone Hydrochloride500 in 1 BOTTLETABLET50030
50111-561-03Trazodone Hydrochloride1000 in 1 BOTTLETABLET100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-561-01EA - Each50111-561977fa415-e7ff-4952-97b3-88cddc4f3c0912021-01-08
50111-561-02EA - Each50111-561f556bdc9-6277-4784-9987-275a0353990312021-01-08

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
50111-561TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]28Current NDC, Legacy NDC, 3 package rows20230210_4006d439-e2de-4590-82e9-fc9d56e3ec1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNb617348c-cb19-45df-b313-4ea6af6f1dda32
856373trazodone hydrochloride 100 MG Oral TabletSCDb617348c-cb19-45df-b313-4ea6af6f1dda32
856373traZODone HCl 100 MG Oral TabletPSNdf17cec9-ad5e-4e57-8572-c927c9b955e230
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
856373trazodone hydrochloride 100 MG Oral TabletSCDdf17cec9-ad5e-4e57-8572-c927c9b955e230
856364trazodone hydrochloride 150 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856377trazodone hydrochloride 50 MG Oral TabletSCD4006d439-e2de-4590-82e9-fc9d56e3ec1b30
856373traZODone HCl 100 MG Oral TabletPSN7bba99e5-4096-4fcb-8591-dc4a9bfe975e13
856373trazodone hydrochloride 100 MG Oral TabletSCD7bba99e5-4096-4fcb-8591-dc4a9bfe975e13
856373traZODone HCl 100 MG Oral TabletPSNb3723265-7455-c25c-e053-2a95a90a379b5
856377traZODone HCl 50 MG Oral TabletPSNb3723265-7455-c25c-e053-2a95a90a379b5
856373trazodone hydrochloride 100 MG Oral TabletSCDb3723265-7455-c25c-e053-2a95a90a379b5
856377trazodone hydrochloride 50 MG Oral TabletSCDb3723265-7455-c25c-e053-2a95a90a379b5
856373traZODone HCl 100 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377traZODone HCl 50 MG Oral TabletPSNd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856373trazodone hydrochloride 100 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856377trazodone hydrochloride 50 MG Oral TabletSCDd42fd0c8-3673-4f18-a6c0-cd276bbf9fef4
856373traZODone HCl 100 MG Oral TabletPSNe07d7ee3-776d-1fa3-e053-2a95a90a70193
856373trazodone hydrochloride 100 MG Oral TabletSCDe07d7ee3-776d-1fa3-e053-2a95a90a70193
856373traZODone HCl 100 MG Oral TabletPSN6ca1bb42-c1f5-4219-8a68-a59f576639172
856373traZODone HCl 100 MG Oral TabletPSN203881a3-37d0-41dd-86c5-1e53fb7843262
856373trazodone hydrochloride 100 MG Oral TabletSCD6ca1bb42-c1f5-4219-8a68-a59f576639172
856373trazodone hydrochloride 100 MG Oral TabletSCD203881a3-37d0-41dd-86c5-1e53fb7843262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-561-0150111056101100 TABLET in 1 BOTTLE (50111-561-01) 100 tablet2020-12-080000-00-00NoNoCurrent
50111-561-0250111056102500 TABLET in 1 BOTTLE (50111-561-02) 500 tablet2020-12-080000-00-00NoNoCurrent
50111-561-03501110561031000 TABLET in 1 BOTTLE (50111-561-03) 1000 tablet2020-10-080000-00-00NoNoCurrent