Citalopram

Product NDC
0904-6084
11-digit product format
009046084
Labeler code
0904
Product ID
0904-6084_5bf8d853-5669-4ef2-940e-6c9075a45ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078216
Marketing category
ANDA
Marketing start
2009-11-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6084-61Citalopram100 in 1 CARTONTABLET, FILM COATED10023
0904-6084-61Citalopram1 in 1 BLISTER PACKTABLET, FILM COATED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6084-61EA - Each0904-60841f6b2593-d712-4de6-8ded-318159de355d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [CARDINAL HEALTH]15
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [MAJOR PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6084CITALOPRAM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]21Current NDC, Legacy NDC, 2 package rows20250227_a6949652-b15b-435b-9097-2219f398ac05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN6c8942f8-963a-4007-a147-b77ac629e4d432
200371citalopram 20 MG Oral TabletPSN6c8942f8-963a-4007-a147-b77ac629e4d432
283672citalopram 10 MG Oral TabletSCD6c8942f8-963a-4007-a147-b77ac629e4d432
200371citalopram 20 MG Oral TabletSCD6c8942f8-963a-4007-a147-b77ac629e4d432
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY6c8942f8-963a-4007-a147-b77ac629e4d432
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY6c8942f8-963a-4007-a147-b77ac629e4d432
283672citalopram 10 MG Oral TabletPSNa6949652-b15b-435b-9097-2219f398ac0523
200371citalopram 20 MG Oral TabletPSNa6949652-b15b-435b-9097-2219f398ac0523
283672citalopram 10 MG Oral TabletSCDa6949652-b15b-435b-9097-2219f398ac0523
200371citalopram 20 MG Oral TabletSCDa6949652-b15b-435b-9097-2219f398ac0523
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYa6949652-b15b-435b-9097-2219f398ac0523
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYa6949652-b15b-435b-9097-2219f398ac0523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6084-6100904608461100 BLISTER PACK in 1 CARTON (0904-6084-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2009-11-020000-00-00NoNoCurrent