Citalopram Hydrobromide

Product NDC
42254-119
11-digit product format
422540119
Labeler code
42254
Product ID
42254-119_3993eb55-f0e8-496c-a496-19dc509699e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 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
42254-119-302019-09-24C16284748780-19350213a-3ca1-c013-e053-90daa90a1393Citalopram Tablets USP
42254-119-902019-09-24C16284748780-19350213a-3ca1-c013-e053-90daa90a1393Citalopram Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-119-30Citalopram Hydrobromide30 in 1 BOTTLETABLET301
42254-119-90Citalopram Hydrobromide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-119-30EA - Each42254-119d1fe4fef-9176-4e9a-aa37-22214302c2d312012-07-24
42254-119-90EA - Each42254-119eab08939-eba9-4688-a8c2-de278c3fb2f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-119CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120420_3993eb55-f0e8-496c-a496-19dc509699e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
200371citalopram 20 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
309314citalopram 40 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
283672citalopram 10 MG Oral TabletSCD3993eb55-f0e8-496c-a496-19dc509699e81
200371citalopram 20 MG Oral TabletSCD3993eb55-f0e8-496c-a496-19dc509699e81
309314citalopram 40 MG Oral TabletSCD3993eb55-f0e8-496c-a496-19dc509699e81
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY3993eb55-f0e8-496c-a496-19dc509699e81
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY3993eb55-f0e8-496c-a496-19dc509699e81
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY3993eb55-f0e8-496c-a496-19dc509699e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-119-304225401193030 in 1 BOTTLEHistorical
42254-119-904225401199090 in 1 BOTTLEHistorical