Citalopram

Product NDC
53808-0227
11-digit product format
538080227
Labeler code
53808
Product ID
53808-0227_6ab2f82f-8e66-446d-83f0-73713b99667e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077031
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0227-12019-10-21C16284748780-1956f9ecf-c1bc-621f-e053-dbdaa90a74adCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0227-1Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0227CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100804_613768da-6140-4c11-affc-85ba8fe92018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN613768da-6140-4c11-affc-85ba8fe920181
309314citalopram 40 MG Oral TabletSCD613768da-6140-4c11-affc-85ba8fe920181
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY613768da-6140-4c11-affc-85ba8fe920181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0227-15380802270130 in 1 BLISTER PACKHistorical