FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
43353-653
11-digit product format
433530653
Labeler code
43353
Product ID
43353-653_79266f41-f728-4daa-9c57-b2a5f3881e17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072193
Marketing category
ANDA
Marketing start
2010-05-30
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
43353-653-302020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-653-532020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-653-602020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-653-802020-01-31C16284748780-19d75b9d0-2380-f424-e053-dadaa90a57ceThese 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
43353-653-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
43353-653-53Trazodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
43353-653-60Trazodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901
43353-653-80Trazodone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-653-30EA - Each43353-6538ec5050f-21b4-4b16-811b-b7fea6cb817812014-06-03
43353-653-53EA - Each43353-6535baaa236-e4f0-4f38-aa55-f522dabddc8812014-06-03
43353-653-60EA - Each43353-653836abc32-50e1-4a50-8f20-8478b702765b12014-06-03
43353-653-80EA - Each43353-65366d47db9-3ac9-4f7f-99c6-efe9670808ec12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-653TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20140513_26d30297-fda9-45a4-b94a-a9f401705818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856377traZODone HCl 50 MG Oral TabletPSN26d30297-fda9-45a4-b94a-a9f4017058181
856373trazodone hydrochloride 100 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181
856377trazodone hydrochloride 50 MG Oral TabletSCD26d30297-fda9-45a4-b94a-a9f4017058181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-653-304335306533030 in 1 BOTTLE, PLASTICHistorical
43353-653-534335306535360 in 1 BOTTLE, PLASTICHistorical
43353-653-604335306536090 in 1 BOTTLE, PLASTICHistorical
43353-653-8043353065380180 in 1 BOTTLE, PLASTICHistorical