FDA.reportPublic FDA data

CITALOPRAM

Product NDC
54458-980
11-digit product format
544580980
Labeler code
54458
Product ID
54458-980_e4ec3325-3ee2-4c6a-af8a-1da984969c06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077038
Marketing category
ANDA
Marketing start
2008-06-25
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-980-102025-01-30C16284748780-12cef2736-a1a3-d83d-e063-dadaa90ab31fCITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet, film coated Citalopram Tablets USP Rx only
54458-980-162025-01-30C16284748780-12cef2736-a1a3-d83d-e063-dadaa90ab31fCITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet, film coated Citalopram Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-980-10CITALOPRAM30 in 1 BLISTER PACKTABLET, FILM COATED3040
54458-980-16CITALOPRAM30 in 1 BOTTLETABLET, FILM COATED3040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-980-10EA - Each54458-980bc7fea78-2997-4c0f-a5e0-0479d57c349012012-07-24
54458-980-16EA - Each54458-980316b957c-930b-4220-842d-1917e1333f5f12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-980CITALOPRAM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]40Legacy NDC, 2 package rows20191219_22edd948-d2fe-4df1-b797-1b7d92fc29cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN22edd948-d2fe-4df1-b797-1b7d92fc29cf40
200371citalopram 20 MG Oral TabletPSN22edd948-d2fe-4df1-b797-1b7d92fc29cf40
309314citalopram 40 MG Oral TabletPSN22edd948-d2fe-4df1-b797-1b7d92fc29cf40
283672citalopram 10 MG Oral TabletSCD22edd948-d2fe-4df1-b797-1b7d92fc29cf40
200371citalopram 20 MG Oral TabletSCD22edd948-d2fe-4df1-b797-1b7d92fc29cf40
309314citalopram 40 MG Oral TabletSCD22edd948-d2fe-4df1-b797-1b7d92fc29cf40
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY22edd948-d2fe-4df1-b797-1b7d92fc29cf40
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY22edd948-d2fe-4df1-b797-1b7d92fc29cf40
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY22edd948-d2fe-4df1-b797-1b7d92fc29cf40

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54458-980-105445809801030 TABLET, FILM COATED in 1 BLISTER PACK (54458-980-10) 2008-06-250000-00-00NoNoCurrent
54458-980-165445809801630 TABLET, FILM COATED in 1 BOTTLE (54458-980-16) 2017-07-170000-00-00NoNoCurrent