Citalopram

Product NDC
53808-0976
11-digit product format
538080976
Labeler code
53808
Product ID
53808-0976_d21388e7-ca03-4759-b7b7-046672762e8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077048
Marketing category
ANDA
Marketing start
2013-01-01
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
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
53808-0976-12020-01-31C16284748780-19d75b9d0-7b7c-f424-e053-dadaa90a57ceCITALOPRAM TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0976-1Citalopram30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0976CITALOPRAM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20140428_52dca069-fd95-4d2c-9779-654b842ccc30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN52dca069-fd95-4d2c-9779-654b842ccc302
309314citalopram 40 MG Oral TabletSCD52dca069-fd95-4d2c-9779-654b842ccc302
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY52dca069-fd95-4d2c-9779-654b842ccc302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0976-15380809760130 in 1 BLISTER PACKHistorical