FDA.reportPublic FDA data

Citalopram

Product NDC
0378-6233
11-digit product format
003786233
Labeler code
0378
Product ID
0378-6233_55e0b75b-3772-4f5b-a162-1f70719daf3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077042
Marketing category
ANDA
Marketing start
2008-07-28
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
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 HYDROBROMIDE40 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
0378-6233-01Citalopram100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019
0378-6233-05Citalopram500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6233-01EA - Each0378-623301168d35-b43c-49f9-beb0-070b80b08e6412012-07-24
0378-6233-05EA - Each0378-6233c58165b4-9f1c-453b-a8b4-fd962de9af9c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CITALOPRAMACTIVE INGREDIENT0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CITALOPRAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6233CITALOPRAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 2 package rows20240915_825c0c49-5fbf-6d8b-cb8c-94ebf0eda043.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG Oral TabletSCD2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
283672citalopram 10 MG Oral TabletPSN825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
200371citalopram 20 MG Oral TabletPSN825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
309314citalopram 40 MG Oral TabletPSN825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
283672citalopram 10 MG Oral TabletSCD825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
200371citalopram 20 MG Oral TabletSCD825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
309314citalopram 40 MG Oral TabletSCD825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY825c0c49-5fbf-6d8b-cb8c-94ebf0eda04319
309314citalopram 40 MG Oral TabletPSNaa9c1440-354f-43a6-9e70-fd7bafcb03c514
309314citalopram 40 MG Oral TabletSCDaa9c1440-354f-43a6-9e70-fd7bafcb03c514
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYaa9c1440-354f-43a6-9e70-fd7bafcb03c514
283672citalopram 10 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG Oral TabletPSN598cc779-06be-b27a-e053-2a91aa0a09093
283672citalopram 10 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG Oral TabletSCD598cc779-06be-b27a-e053-2a91aa0a09093
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY598cc779-06be-b27a-e053-2a91aa0a09093
200371citalopram 20 MG Oral TabletPSNbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG Oral TabletPSNbfccb051-7d05-4457-9823-9b460ee122322
200371citalopram 20 MG Oral TabletSCDbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG Oral TabletSCDbfccb051-7d05-4457-9823-9b460ee122322
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYbfccb051-7d05-4457-9823-9b460ee122322
309314citalopram 40 MG Oral TabletPSN0dfb11d9-f48d-56ee-e063-6294a90ad2561
309314citalopram 40 MG Oral TabletSCD0dfb11d9-f48d-56ee-e063-6294a90ad2561
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY0dfb11d9-f48d-56ee-e063-6294a90ad2561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6233-0100378623301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6233-01) 2008-07-280000-00-00NoNoCurrent
0378-6233-0500378623305500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6233-05) 2008-07-280000-00-00NoNoCurrent