CITALOPRAM

Product NDC
42806-021
11-digit product format
428060021
Labeler code
42806
Product ID
42806-021_b7f54932-2c8c-44f4-acc6-d9e2b3914be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA077045
Marketing category
ANDA
Marketing start
2011-05-20
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
42806-021-01CITALOPRAM100 in 1 BOTTLETABLET, FILM COATED10015
42806-021-05CITALOPRAM500 in 1 BOTTLETABLET, FILM COATED50015
42806-021-10CITALOPRAM1000 in 1 BOTTLETABLET, FILM COATED100015
42806-021-30CITALOPRAM30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-021-01EA - Each42806-02161d9ec76-ff02-497c-b1f1-f138e46cfb0a12012-07-24
42806-021-10EA - Each42806-0213574f99d-53a0-4df8-982d-0b0a4ac988b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]7
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]4
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-021CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC]15Current NDC, Legacy NDC, 4 package rows20241222_08b6d5da-5919-4760-9e16-3b478a14d6d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG Oral TabletPSN08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG Oral TabletSCD08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY08b6d5da-5919-4760-9e16-3b478a14d6d715
283672citalopram 10 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletPSNf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG Oral TabletSCDf3a26d92-b662-4896-82eb-26194804240813
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf3a26d92-b662-4896-82eb-26194804240813
200371citalopram 20 MG Oral TabletPSN5dcf0419-355b-4751-bf4c-2d45b1be93a64
309314citalopram 40 MG Oral TabletPSN5dcf0419-355b-4751-bf4c-2d45b1be93a64
200371citalopram 20 MG Oral TabletSCD5dcf0419-355b-4751-bf4c-2d45b1be93a64
309314citalopram 40 MG Oral TabletSCD5dcf0419-355b-4751-bf4c-2d45b1be93a64
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY5dcf0419-355b-4751-bf4c-2d45b1be93a64
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY5dcf0419-355b-4751-bf4c-2d45b1be93a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-021-0142806002101100 TABLET, FILM COATED in 1 BOTTLE (42806-021-01) 2011-05-200000-00-00NoNoCurrent
42806-021-0542806002105500 in 1 BOTTLEHistorical
42806-021-10428060021101000 TABLET, FILM COATED in 1 BOTTLE (42806-021-10) 2011-05-200000-00-00NoNoCurrent
42806-021-304280600213030 TABLET, FILM COATED in 1 BOTTLE (42806-021-30) 2011-05-200000-00-00NoNoCurrent