FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
53002-1132
11-digit product format
530021132
Labeler code
53002
Product ID
53002-1132_994e9daa-4a90-4963-badc-c9d7c8de7b68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA071523
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-1132-02025-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-12025-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-32025-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-62025-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-02023-06-07C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-12023-06-07C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-32023-06-07C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-62023-06-07C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-02023-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-12023-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-32023-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-62023-01-30C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-02020-12-15C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-12020-12-15C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-32020-12-15C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-62020-12-15C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-02020-01-31C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-12020-01-31C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-32020-01-31C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-62020-01-31C16284748780-19d75b9d0-f997-f424-e053-dadaa90a57ceThese 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
53002-1132-0Trazodone Hydrochloride100 in 1 BOTTLETABLET1007
53002-1132-1Trazodone Hydrochloride10 in 1 BOTTLETABLET107
53002-1132-3Trazodone Hydrochloride30 in 1 BOTTLETABLET307
53002-1132-6Trazodone Hydrochloride60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1132TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 4 package rows20230609_8c859876-6b45-45b3-9eb2-5c7a5ea7a26f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN8c859876-6b45-45b3-9eb2-5c7a5ea7a26f7
856377traZODone HCl 50 MG Oral TabletPSN8c859876-6b45-45b3-9eb2-5c7a5ea7a26f7
856373trazodone hydrochloride 100 MG Oral TabletSCD8c859876-6b45-45b3-9eb2-5c7a5ea7a26f7
856377trazodone hydrochloride 50 MG Oral TabletSCD8c859876-6b45-45b3-9eb2-5c7a5ea7a26f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1132-053002113200100 TABLET in 1 BOTTLE (53002-1132-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1132-15300211320110 TABLET in 1 BOTTLE (53002-1132-1) 10 tablet2017-09-010000-00-00NoNoCurrent
53002-1132-35300211320330 TABLET in 1 BOTTLE (53002-1132-3) 30 tablet2017-09-010000-00-00NoNoCurrent
53002-1132-65300211320660 TABLET in 1 BOTTLE (53002-1132-6) 60 tablet2017-09-010000-00-00NoNoCurrent