FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68071-4761
11-digit product format
680714761
Labeler code
68071
Product ID
68071-4761_21b1cda6-ae50-5646-e063-6294a90ab8cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmceuticals,Inc.
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
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
Rxcui856373

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
68071-4761-32024-06-14C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-52024-06-14C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-92024-06-14C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-32023-01-30C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-52023-01-30C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-92023-01-30C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-92021-02-17C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-92021-01-29C16284748780-1ba0f9c33-2758-a910-e053-dadaa90a0b85These 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
68071-4761-3Trazodone Hydrochloride30 in 1 BOTTLETABLET306
68071-4761-5Trazodone Hydrochloride45 in 1 BOTTLETABLET456
68071-4761-9Trazodone Hydrochloride90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4761TRAZODONE HYDROCHLORIDE TABLET [NUCARE PHARMCEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20240910_81a5b557-06f6-2470-e053-2991aa0a64fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN81a5b557-06f6-2470-e053-2991aa0a64fd6
856373trazodone hydrochloride 100 MG Oral TabletSCD81a5b557-06f6-2470-e053-2991aa0a64fd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4761-36807147610330 TABLET in 1 BOTTLE (68071-4761-3) 30 tablet2019-02-110000-00-00NoNoCurrent
68071-4761-56807147610545 TABLET in 1 BOTTLE (68071-4761-5) 45 tablet2019-02-110000-00-00NoNoCurrent
68071-4761-96807147610990 TABLET in 1 BOTTLE (68071-4761-9) 90 tablet2019-02-110000-00-00NoNoCurrent