FDA.reportPublic FDA data

Citalopram

Product NDC
21695-031
11-digit product format
216950031
Labeler code
21695
Product ID
21695-031_a0fdcf12-0e79-4814-910f-5f4cc7463c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-03-27
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 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
21695-031-002019-09-24C16284748780-1934fe258-49da-48b1-e053-8cdaa90a720aCitalopram Tablets, USP
21695-031-302019-09-24C16284748780-1934fe258-49da-48b1-e053-8cdaa90a720aCitalopram Tablets, USP
21695-031-902019-09-24C16284748780-1934fe258-49da-48b1-e053-8cdaa90a720aCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-031-00Citalopram100 in 1 BOTTLETABLET, FILM COATED1002
21695-031-30Citalopram30 in 1 BOTTLETABLET, FILM COATED302
21695-031-60Citalopram60 in 1 BOTTLETABLET, FILM COATED602
21695-031-90Citalopram90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-031-00EA - Each21695-031dca247e8-455e-4ed7-9109-17f8cdaea90e12012-07-24
21695-031-30EA - Each21695-031b2492d86-4e22-492c-9e36-c866baf32dc512012-07-24
21695-031-60EA - Each21695-031f442cd9e-5810-4d4e-b601-301b1b142d6312012-07-24
21695-031-90EA - Each21695-03131369045-7b4b-4cb3-a765-1724b50c188712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-031CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 4 package rows20100324_b29fab7c-1282-4bb9-a650-24890501caec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNb29fab7c-1282-4bb9-a650-24890501caec2
200371citalopram 20 MG Oral TabletPSNb29fab7c-1282-4bb9-a650-24890501caec2
309314citalopram 40 MG Oral TabletPSNb29fab7c-1282-4bb9-a650-24890501caec2
283672citalopram 10 MG Oral TabletSCDb29fab7c-1282-4bb9-a650-24890501caec2
200371citalopram 20 MG Oral TabletSCDb29fab7c-1282-4bb9-a650-24890501caec2
309314citalopram 40 MG Oral TabletSCDb29fab7c-1282-4bb9-a650-24890501caec2
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYb29fab7c-1282-4bb9-a650-24890501caec2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYb29fab7c-1282-4bb9-a650-24890501caec2
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYb29fab7c-1282-4bb9-a650-24890501caec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-031-0021695003100100 in 1 BOTTLEHistorical
21695-031-302169500313030 in 1 BOTTLEHistorical
21695-031-602169500316060 in 1 BOTTLEHistorical
21695-031-902169500319090 in 1 BOTTLEHistorical