FDA.reportPublic FDA data

Citalopram

Product NDC
63187-140
11-digit product format
631870140
Labeler code
63187
Product ID
63187-140_288c3af7-acd9-4c1d-a4b5-8ae7aee4549f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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
63187-140-30Citalopram30 in 1 BOTTLETABLET, FILM COATED306
63187-140-60Citalopram60 in 1 BOTTLETABLET, FILM COATED606
63187-140-90Citalopram90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-140CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20220507_f37cc307-8b7d-4e5c-8beb-cd8779bc86a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNf37cc307-8b7d-4e5c-8beb-cd8779bc86a76
309314citalopram 40 MG Oral TabletSCDf37cc307-8b7d-4e5c-8beb-cd8779bc86a76
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf37cc307-8b7d-4e5c-8beb-cd8779bc86a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-140-306318701403030 TABLET, FILM COATED in 1 BOTTLE (63187-140-30) 2018-12-010000-00-00NoNoCurrent
63187-140-606318701406060 TABLET, FILM COATED in 1 BOTTLE (63187-140-60) 2018-12-010000-00-00NoNoCurrent
63187-140-906318701409090 TABLET, FILM COATED in 1 BOTTLE (63187-140-90) 2018-12-010000-00-00NoNoCurrent