Citalopram

Product NDC
53808-0906
11-digit product format
538080906
Labeler code
53808
Product ID
53808-0906_3b9c1dbd-4ce0-45bc-a469-a688ec2b0bae
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
2014-01-01
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-0906-12020-01-31C16284748780-19d75b9d0-919f-f424-e053-dadaa90a57cefb0b4228-33bd-4899-8b46-be5e9d4606d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0906-1Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0906CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_fb0b4228-33bd-4899-8b46-be5e9d4606d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNfb0b4228-33bd-4899-8b46-be5e9d4606d01
283672citalopram 10 MG Oral TabletSCDfb0b4228-33bd-4899-8b46-be5e9d4606d01
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYfb0b4228-33bd-4899-8b46-be5e9d4606d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0906-15380809060130 in 1 BLISTER PACKHistorical