FDA.reportPublic FDA data

CITALOPRAM

Product NDC
60429-175
11-digit product format
604290175
Labeler code
60429
Product ID
60429-175_2bb26393-e61c-3ff0-e063-6394a90aea5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077045
Marketing category
ANDA
Marketing start
2005-04-29
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
Rxcui200371, 283672, 309314

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
60429-175-01CITALOPRAM100 in 1 BOTTLETABLET, FILM COATED10013
60429-175-10CITALOPRAM1000 in 1 BOTTLETABLET, FILM COATED100013
60429-175-30CITALOPRAM30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-175CITALOPRAM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]13Current NDC, Legacy NDC, 3 package rows20250119_f3a26d92-b662-4896-82eb-261948042408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
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
60429-175-0160429017501100 TABLET, FILM COATED in 1 BOTTLE (60429-175-01) 2011-05-200000-00-00NoNoCurrent
60429-175-10604290175101000 TABLET, FILM COATED in 1 BOTTLE (60429-175-10) 2011-05-200000-00-00NoNoCurrent
60429-175-306042901753030 in 1 BOTTLEHistorical