FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
42291-868
11-digit product format
422910868
Labeler code
42291
Product ID
42291-868_4cc4b32a-0db0-e922-e063-6294a90ab8cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA071523
Marketing category
ANDA
Marketing start
2020-11-06
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856373, 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
42291-868-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10005
42291-868-90Trazodone Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-868TRAZODONE HYDROCHLORIDE TABLET [AVKARE]3Current NDC, Legacy NDC, 2 package rows20240111_b3723265-7455-c25c-e053-2a95a90a379b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSN5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856377traZODone HCl 50 MG Oral TabletPSN5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856373trazodone hydrochloride 100 MG Oral TabletSCD5ab590d8-225f-43f4-bb68-1f2c86f9a8863
856377trazodone hydrochloride 50 MG Oral TabletSCD5ab590d8-225f-43f4-bb68-1f2c86f9a8863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-868-10422910868101000 TABLET in 1 BOTTLE (42291-868-10) 1000 tablet2020-11-060000-00-00NoNoCurrent
42291-868-904229108689090 TABLET in 1 BOTTLE (42291-868-90) 90 tablet2020-11-060000-00-00NoNoCurrent