Citalopram

Product NDC
43063-481
11-digit product format
430630481
Labeler code
43063
Product ID
43063-481_509b6eb5-ff44-49ee-e063-6394a90ab96b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
Rxcui283672

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
43063-481-05Citalopram5 in 1 BOTTLE, PLASTICTABLET, FILM COATED530
43063-481-30Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-481-05EA - Each43063-481cac434c2-673b-47c5-9303-425d882579f312015-05-05
43063-481-30EA - Each43063-48186e344cc-7060-41fb-9987-edf5cebc6cba12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-481CITALOPRAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]29Current NDC, Legacy NDC, 2 package rows20250306_df929b3f-0cda-4a75-96d3-22e6b0edbbc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNdf929b3f-0cda-4a75-96d3-22e6b0edbbc930
283672citalopram 10 MG Oral TabletSCDdf929b3f-0cda-4a75-96d3-22e6b0edbbc930
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYdf929b3f-0cda-4a75-96d3-22e6b0edbbc930

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-481-05430630481055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-481-05) 2015-04-030000-00-00NoNoCurrent
43063-481-304306304813030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-481-30) 2016-10-270000-00-00NoNoCurrent