FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
57664-053
11-digit product format
576640053
Labeler code
57664
Product ID
57664-053_323e3d63-4d8d-7088-e063-6294a90abb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073137
Marketing category
ANDA
Marketing start
2022-10-03
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
57664-053-72Trazodone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
57664-053-74Trazodone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-053-72EA - Each57664-05331afe7c8-d1f8-4003-be23-1318641e6c3d12024-07-12
57664-053-74EA - Each57664-05348dc0da3-d099-453e-9934-df3b821ed03312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-053TRAZODONE HYDROCHLORIDE TABLET, FILM COATED TRAZODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, 2 package rows20250412_f291b905-a739-5e43-e053-2995a90ac40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856364traZODone HCl 150 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856377traZODone HCl 50 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856373trazodone hydrochloride 100 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4
856364trazodone hydrochloride 150 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4
856377trazodone hydrochloride 50 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57664-053-7257664005372100 TABLET in 1 BOTTLE, PLASTIC (57664-053-72) 100 tablet2022-10-03NoNoHistorical
57664-053-7457664005374500 TABLET in 1 BOTTLE, PLASTIC (57664-053-74) 500 tablet2022-10-03NoNoHistorical