FDA.reportPublic FDA data

Citalopram

Product NDC
72789-071
11-digit product format
727890071
Labeler code
72789
Product ID
72789-071_47a90e31-b173-de79-e063-6394a90a05b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

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
72789-071-30Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3025
72789-071-90Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-071-30EA - Each72789-0711e7f9848-9b27-4b07-ab56-7321e11f6db912020-07-13
72789-071-90EA - Each72789-07153a46d3c-f63f-4de8-9d16-a93e89498f3d12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-071CITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 2 package rows20240829_9fe40d83-8945-4577-add5-28d52410154e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN9fe40d83-8945-4577-add5-28d52410154e25
309314citalopram 40 MG Oral TabletSCD9fe40d83-8945-4577-add5-28d52410154e25
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY9fe40d83-8945-4577-add5-28d52410154e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-071-307278900713030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-071-30) 2020-05-150000-00-00NoNoCurrent
72789-071-907278900719090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-071-90) 2020-03-300000-00-00NoNoCurrent