Citalopram

Product NDC
43353-778
11-digit product format
433530778
Labeler code
43353
Product ID
43353-778_e2548afb-c594-4b3a-8557-162db8daa689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077045
Marketing category
ANDA
Marketing start
2011-05-20
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-778-15Citalopram15 in 1 BOTTLETABLET, FILM COATED152
43353-778-45Citalopram45 in 1 BOTTLETABLET, FILM COATED452
43353-778-60Citalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-778-15EA - Each43353-778067a0c57-a5b9-4eec-aa1e-c984b4ef664a12017-12-14
43353-778-45EA - Each43353-7788a92372f-0c05-4aa3-ae51-fec49d55cd1b12017-12-14
43353-778-60EA - Each43353-77881a668f9-9164-4127-a83c-7ed733be863612017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-778CITALOPRAM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20190227_2fae4dd4-e4ca-4237-aab8-4079856d6bb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN2fae4dd4-e4ca-4237-aab8-4079856d6bb02
200371citalopram 20 MG Oral TabletSCD2fae4dd4-e4ca-4237-aab8-4079856d6bb02
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY2fae4dd4-e4ca-4237-aab8-4079856d6bb02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-778-154335307781515 in 1 BOTTLEHistorical
43353-778-454335307784545 in 1 BOTTLEHistorical
43353-778-604335307786090 in 1 BOTTLEHistorical