Citalopram

Product NDC
53401-201
11-digit product format
534010201
Labeler code
53401
Product ID
53401-201_a7295887-cfd9-4422-9395-01a77676c9f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - New Jersey, LLC
Application
ANDA077289
Marketing category
ANDA
Marketing start
2010-09-13
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
E
Listing certified through
2017-12-31
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
53401-201-302019-11-27C16284748780-19855d018-e0ea-cd31-e053-dbdaa90ab51aCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53401-201-30Citalopram30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]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 YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53401-201CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]1Legacy NDC, 1 package rows20130502_bbac6a86-b329-459c-9683-4818f36ab502.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG Oral TabletPSNbbac6a86-b329-459c-9683-4818f36ab5021
283672citalopram 10 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG Oral TabletSCDbbac6a86-b329-459c-9683-4818f36ab5021
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYbbac6a86-b329-459c-9683-4818f36ab5021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53401-201-305340102013030 in 1 BLISTER PACKHistorical