FDA.reportPublic FDA data

Citalopram

Product NDC
71610-422
11-digit product format
716100422
Labeler code
71610
Product ID
71610-422_5b7791df-471c-4407-a795-ad43aba3142d
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
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309314

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
71610-422-45Citalopram45 in 1 BOTTLETABLET, FILM COATED451
71610-422-60Citalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-422-45EA - Each71610-42204cb7ead-c045-449c-ab91-f12f03ab87da12020-07-13
71610-422-60EA - Each71610-42219859654-841d-4d90-8940-d06fd50466b512020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-422CITALOPRAM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20200527_3d70380f-ef97-4de9-a8f8-44ef9ba7e5a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71
309314citalopram 40 MG Oral TabletSCD3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY3d70380f-ef97-4de9-a8f8-44ef9ba7e5a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-422-457161004224545 TABLET, FILM COATED in 1 BOTTLE (71610-422-45) 2020-05-010000-00-00NoNoCurrent
71610-422-607161004226090 TABLET, FILM COATED in 1 BOTTLE (71610-422-60) 2020-05-180000-00-00NoNoCurrent