FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68071-2959
11-digit product format
680712959
Labeler code
68071
Product ID
68071-2959_3cd49b8b-cb57-a680-e063-6394a90a5b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202180
Marketing category
ANDA
Marketing start
2013-11-27
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
68071-2959-32025-08-20C16284748780-12cef2736-ae4e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS, USP. TRAZODONE HYDROCHLORIDE tablets, USP for oral use Initial U.S. Approval: 1981
68071-2959-32025-01-30C16284748780-12cef2736-ae4e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS, USP. TRAZODONE HYDROCHLORIDE tablets, USP for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2959-3Trazodone Hydrochloride30 in 1 BOTTLETABLET302
68071-2959-6Trazodone Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2959TRAZODONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 2 package rows20230328_f7e6a78e-7ac3-35b9-e053-6294a90aabd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNf7e6a78e-7ac3-35b9-e053-6294a90aabd02
856373trazodone hydrochloride 100 MG Oral TabletSCDf7e6a78e-7ac3-35b9-e053-6294a90aabd02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2959-36807129590330 TABLET in 1 BOTTLE (68071-2959-3) 30 tablet2023-03-27NoNoCurrent
68071-2959-66807129590660 TABLET in 1 BOTTLE (68071-2959-6) 60 tablet2023-03-27NoNoCurrent