Citalopram

Product NDC
10544-006
11-digit product format
105440006
Labeler code
10544
Product ID
10544-006_d9785b1d-f224-42cc-9f46-402feb3f9b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2010-07-06
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
10544-006-302020-01-31C16284748780-19d75b9d0-2de2-f424-e053-dadaa90a57ceCitalopram Hydrobromide Tablets, USP
10544-006-902020-01-31C16284748780-19d75b9d0-2de2-f424-e053-dadaa90a57ceCitalopram Hydrobromide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-006-30Citalopram30 in 1 BOTTLETABLET301
10544-006-90Citalopram90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-006-30EA - Each10544-006c39c1334-7b4e-4c75-b7bf-a6c0b2db8c9d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-006CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150306_d9785b1d-f224-42cc-9f46-402feb3f9b15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNd9785b1d-f224-42cc-9f46-402feb3f9b151
200371citalopram 20 MG Oral TabletSCDd9785b1d-f224-42cc-9f46-402feb3f9b151
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYd9785b1d-f224-42cc-9f46-402feb3f9b151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-006-301054400063030 in 1 BOTTLEHistorical
10544-006-901054400069090 in 1 BOTTLEHistorical