FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
71335-1483
11-digit product format
713351483
Labeler code
71335
Product ID
71335-1483_4fe0cdc9-bc0d-45ae-a3bf-b4ae5e4f55ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206923
Marketing category
ANDA
Marketing start
2018-10-17
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1483-12024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-22024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-32024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-42024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-52024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-62024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-72024-05-20C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-12024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-22024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-32024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-42024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-52024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-62024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
71335-1483-72024-01-30C16284748780-11030e365-0d53-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1483-1Trazodone Hydrochloride30 in 1 BOTTLETABLET305
71335-1483-2Trazodone Hydrochloride60 in 1 BOTTLETABLET605
71335-1483-3Trazodone Hydrochloride90 in 1 BOTTLETABLET905
71335-1483-4Trazodone Hydrochloride18 in 1 BOTTLETABLET185
71335-1483-5Trazodone Hydrochloride100 in 1 BOTTLETABLET1005
71335-1483-6Trazodone Hydrochloride45 in 1 BOTTLETABLET455
71335-1483-7Trazodone Hydrochloride180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1483TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 7 package rows20240522_5605e909-dc75-4578-94c6-41bb96ba3e2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN5605e909-dc75-4578-94c6-41bb96ba3e2a5
856364trazodone hydrochloride 150 MG Oral TabletSCD5605e909-dc75-4578-94c6-41bb96ba3e2a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1483-17133514830130 TABLET in 1 BOTTLE (71335-1483-1) 30 tablet2020-01-150000-00-00NoNoCurrent
71335-1483-27133514830260 TABLET in 1 BOTTLE (71335-1483-2) 60 tablet2020-03-130000-00-00NoNoCurrent
71335-1483-37133514830390 TABLET in 1 BOTTLE (71335-1483-3) 90 tablet2021-08-120000-00-00NoNoCurrent
71335-1483-47133514830418 TABLET in 1 BOTTLE (71335-1483-4) 18 tablet2022-02-140000-00-00NoNoCurrent
71335-1483-571335148305100 TABLET in 1 BOTTLE (71335-1483-5) 100 tablet2022-02-140000-00-00NoNoCurrent
71335-1483-67133514830645 TABLET in 1 BOTTLE (71335-1483-6) 45 tablet2022-02-140000-00-00NoNoCurrent
71335-1483-771335148307180 TABLET in 1 BOTTLE (71335-1483-7) 180 tablet2022-02-140000-00-00NoNoCurrent