Citalopram

Product NDC
58517-100
11-digit product format
585170100
Labeler code
58517
Product ID
58517-100_308c2e2e-f9ef-47e3-bacb-5e0f4fea5814
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
New Horizon Rx Group, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2013-08-25
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58517-100-302025-06-16C16284748780-19855e2a2-50d9-60a7-e053-dbdaa90a05bd7c440f9d-6843-4502-80df-4ecec9059e9c
58517-100-302019-11-27C16284748780-19855e2a2-50d9-60a7-e053-dbdaa90a05bd7c440f9d-6843-4502-80df-4ecec9059e9c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58517-100-30EA - Each58517-100d9f050fd-c1a9-4d7c-b069-7a252ab3e32f12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58517-100CITALOPRAM TABLET [NEW HORIZON RX GROUP, LLC]5Legacy NDC20140103_7c440f9d-6843-4502-80df-4ecec9059e9c.zip