FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
33261-385
11-digit product format
332610385
Labeler code
33261
Product ID
33261-385_ed1631ee-9ac0-4936-9749-e6be6ef1aa44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071524
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-385-142020-01-31C16284748780-19d75b9d1-171f-f424-e053-dadaa90a57ceTRAZODONE HYDROCHLORIDE TABLETS, USP
33261-385-302020-01-31C16284748780-19d75b9d1-171f-f424-e053-dadaa90a57ceTRAZODONE HYDROCHLORIDE TABLETS, USP
33261-385-602020-01-31C16284748780-19d75b9d1-171f-f424-e053-dadaa90a57ceTRAZODONE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-385-14Trazodone Hydrochloride14 in 1 BOTTLETABLET141
33261-385-30Trazodone Hydrochloride30 in 1 BOTTLETABLET301
33261-385-60Trazodone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-385-30EA - Each33261-38562e3058a-04ae-4f08-897c-1a46c7cf0f2a12015-10-02
33261-385-60EA - Each33261-38544bbbcc5-8294-4133-b8a3-4a982ac1fc2912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-385TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20121013_3f8d7e17-b580-4340-bd8f-e76f8ba00422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856364traZODone HCl 150 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856377traZODone HCl 50 MG Oral TabletPSN3f8d7e17-b580-4340-bd8f-e76f8ba004221
856373trazodone hydrochloride 100 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221
856364trazodone hydrochloride 150 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221
856377trazodone hydrochloride 50 MG Oral TabletSCD3f8d7e17-b580-4340-bd8f-e76f8ba004221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-385-143326103851414 in 1 BOTTLEHistorical
33261-385-303326103853030 in 1 BOTTLEHistorical
33261-385-603326103856060 in 1 BOTTLEHistorical