FDA.reportPublic FDA data

Citalopram

Product NDC
53002-1359
11-digit product format
530021359
Labeler code
53002
Product ID
53002-1359_5e4d4f80-95ca-495a-a6c0-af51282e2cd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
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
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1359-02025-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-32025-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-62025-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-02023-06-07C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-32023-06-07C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-62023-06-07C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-02023-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-32023-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-62023-01-30C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-02020-12-15C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-32020-12-15C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-62020-12-15C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-02020-01-31C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-32020-01-31C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
53002-1359-62020-01-31C16284748780-19d75b9d0-c712-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1359-0Citalopram100 in 1 BOTTLETABLET, FILM COATED1006
53002-1359-3Citalopram30 in 1 BOTTLETABLET, FILM COATED306
53002-1359-6Citalopram60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1359CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 3 package rows20230609_c0175164-03a6-41bb-91d6-e1ee78b2d070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
200371citalopram 20 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc0175164-03a6-41bb-91d6-e1ee78b2d0706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1359-053002135900100 TABLET, FILM COATED in 1 BOTTLE (53002-1359-0) 2017-09-010000-00-00NoNoCurrent
53002-1359-35300213590330 TABLET, FILM COATED in 1 BOTTLE (53002-1359-3) 2017-09-010000-00-00NoNoCurrent
53002-1359-65300213590660 TABLET, FILM COATED in 1 BOTTLE (53002-1359-6) 2017-09-010000-00-00NoNoCurrent