FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
51655-664
11-digit product format
516550664
Labeler code
51655
Product ID
51655-664_ca3abb22-e8c8-2aaa-e053-2a95a90aa427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2015-02-16
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
2022-12-31
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
51655-664-252026-01-29C16284748780-19d75b9d0-1c69-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
51655-664-262026-01-29C16284748780-19d75b9d0-1c69-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
51655-664-522026-01-29C16284748780-19d75b9d0-1c69-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
51655-664-252023-04-18C16284748780-19d75b9d0-1c69-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
51655-664-522023-04-18C16284748780-19d75b9d0-1c69-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
51655-664-252023-01-30C16284748780-19d75b9d0-1c69-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
51655-664-522023-01-30C16284748780-19d75b9d0-1c69-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
51655-664-522021-08-23C16284748780-19d75b9d0-1c69-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
51655-664-522020-01-31C16284748780-19d75b9d0-1c69-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
51655-664-25Citalopram Hydrobromide60 in 1 BOTTLE, DISPENSINGTABLET605
51655-664-26Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET905
51655-664-52Citalopram Hydrobromide30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-664CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Legacy NDC, 3 package rows20240727_a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
200371citalopram 20 MG Oral TabletSCDa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletSCDa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-664-255165506642560 TABLET in 1 BOTTLE, DISPENSING (51655-664-25) 60 tablet2020-12-100000-00-00NoNoCurrent
51655-664-265165506642690 in 1 BOTTLE, PLASTICHistorical
51655-664-525165506645230 TABLET in 1 BOTTLE, DISPENSING (51655-664-52) 30 tablet2015-02-160000-00-00NoNoCurrent