FDA.reportPublic FDA data

Citalopram

Product NDC
65162-053
11-digit product format
651620053
Labeler code
65162
Product ID
65162-053_a42ab6f8-0664-4d9d-9da0-116bba7e55fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA077289
Marketing category
ANDA
Marketing start
2010-04-06
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672, 309314

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
65162-053-03Citalopram30 in 1 BOTTLETABLET3030
65162-053-10Citalopram100 in 1 BOTTLETABLET10030
65162-053-11Citalopram1000 in 1 BOTTLETABLET100030
65162-053-50Citalopram500 in 1 BOTTLETABLET50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-053-03EA - Each65162-0533323b512-e062-4b77-882e-415e64ea6e1d12013-02-13
65162-053-10EA - Each65162-05308780f7f-85f9-49e2-b8f2-a2a99220c2ac12012-07-24
65162-053-50EA - Each65162-0532ca1b477-90f6-49b9-a75a-a512f9b990b212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
TALCINACTIVE INGREDIENT7SEV7J4R1UCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]17
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.]9
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-053CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS LLC]30Current NDC, Legacy NDC, 4 package rows20240925_6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
200371citalopram 20 MG Oral TabletPSN6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
309314citalopram 40 MG Oral TabletPSN6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
283672citalopram 10 MG Oral TabletSCD6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
200371citalopram 20 MG Oral TabletSCD6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
309314citalopram 40 MG Oral TabletSCD6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a30
200371citalopram 20 MG Oral TabletPSN75f6db65-e4ed-470a-9e56-12791f22ee9b29
200371citalopram 20 MG Oral TabletSCD75f6db65-e4ed-470a-9e56-12791f22ee9b29
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY75f6db65-e4ed-470a-9e56-12791f22ee9b29
283672citalopram 10 MG Oral TabletPSNdce6a871-db80-4b59-9b30-ff970a05fa351
283672citalopram 10 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletPSNdce6a871-db80-4b59-9b30-ff970a05fa351
309314citalopram 40 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG Oral TabletPSNdce6a871-db80-4b59-9b30-ff970a05fa351
283672citalopram 10 MG Oral TabletSCDdce6a871-db80-4b59-9b30-ff970a05fa351
283672citalopram 10 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletSCDdce6a871-db80-4b59-9b30-ff970a05fa351
309314citalopram 40 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG Oral TabletSCDdce6a871-db80-4b59-9b30-ff970a05fa351
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYdce6a871-db80-4b59-9b30-ff970a05fa351
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYdce6a871-db80-4b59-9b30-ff970a05fa351
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYdce6a871-db80-4b59-9b30-ff970a05fa351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-053-036516200530330 TABLET in 1 BOTTLE (65162-053-03) 30 tablet2010-04-060000-00-00NoNoCurrent
65162-053-1065162005310100 TABLET in 1 BOTTLE (65162-053-10) 100 tablet2010-04-060000-00-00NoNoCurrent
65162-053-11651620053111000 TABLET in 1 BOTTLE (65162-053-11) 1000 tablet2010-04-060000-00-00NoNoCurrent
65162-053-5065162005350500 TABLET in 1 BOTTLE (65162-053-50) 500 tablet2010-04-060000-00-00NoNoCurrent