FDA.reportPublic FDA data

CITALOPRAM HYDROBROMIDE

Product NDC
43353-208
11-digit product format
433530208
Labeler code
43353
Product ID
43353-208_15b2d425-9b35-4453-b086-2a77d1d5af33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2012-10-01
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
2020-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-208-15CITALOPRAM HYDROBROMIDE15 in 1 BOTTLETABLET156
43353-208-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET306
43353-208-45CITALOPRAM HYDROBROMIDE45 in 1 BOTTLETABLET456
43353-208-60CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-208-15EA - Each43353-2084a18177a-0535-483a-9e88-5236c16a977612017-11-06
43353-208-30EA - Each43353-2084495e545-0645-4671-b661-f2ed9af3fb4512018-02-20
43353-208-45EA - Each43353-208604ea6dc-4af6-4ed0-9f93-c3ddddf48e1f12017-11-06
43353-208-60EA - Each43353-208d224e909-9d0b-4c30-b764-84827721377412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-208CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 4 package rows20171026_7307df53-d570-4e26-971d-e97522ccce7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-208-154335302081515 TABLET in 1 BOTTLE (43353-208-15) 15 tablet2016-08-150000-00-00NoNoCurrent
43353-208-304335302083030 TABLET in 1 BOTTLE (43353-208-30) 30 tablet2017-07-250000-00-00NoNoCurrent
43353-208-454335302084545 TABLET in 1 BOTTLE (43353-208-45) 45 tablet2016-08-150000-00-00NoNoCurrent
43353-208-604335302086090 TABLET in 1 BOTTLE (43353-208-60) 90 tablet2017-02-040000-00-00NoNoCurrent