Citalopram

Product NDC
53808-0226
11-digit product format
538080226
Labeler code
53808
Product ID
53808-0226_fdee2c6d-0343-43e4-9031-aea90341e5ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077042
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CITALOPRAM
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
53808-0226-12020-01-31C16284748780-19d75b9d0-8a07-f424-e053-dadaa90a57cebfccb051-7d05-4457-9823-9b460ee12232

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0226-1Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAMACTIVE INGREDIENT0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0226CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100813_bfccb051-7d05-4457-9823-9b460ee12232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG Oral TabletPSNbfccb051-7d05-4457-9823-9b460ee122322
200371citalopram 20 MG Oral TabletSCDbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG Oral TabletSCDbfccb051-7d05-4457-9823-9b460ee122322
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYbfccb051-7d05-4457-9823-9b460ee122322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0226-15380802260130 in 1 BLISTER PACKHistorical