FDA.reportPublic FDA data

Citalopram

Product NDC
42708-091
11-digit product format
427080091
Labeler code
42708
Product ID
42708-091_5154a3a8-aa0d-ddad-e063-6294a90a62a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
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 HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-091-302021-03-12C16284748780-1ba0f9c33-516e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
42708-091-302021-03-12C16284748780-1ba0f9c33-516e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
42708-091-302021-01-29C16284748780-1ba0f9c33-516e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
42708-091-302021-01-29C16284748780-1ba0f9c33-516e-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-091-30Citalopram30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-091CITALOPRAM TABLET, FILM COATED [QPHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20250522_f35bfd9e-afb6-409d-a804-6073d812609d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNf35bfd9e-afb6-409d-a804-6073d812609d9
200371citalopram 20 MG Oral TabletSCDf35bfd9e-afb6-409d-a804-6073d812609d9
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYf35bfd9e-afb6-409d-a804-6073d812609d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-091-304270800913030 TABLET, FILM COATED in 1 BOTTLE (42708-091-30) 2018-03-210000-00-00YesNoCurrent