CITALOPRAM- citalopram tablet, film coated 
DIRECT RX

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CITALOPRAM 10mg 30 TABS

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS PART 2

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

ANIMAL TOXICOLOGY

Medication Guide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CITALOPRAM 10mg 30 TABS

CITALOPRAM 
citalopram tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-288(NDC:65162-052)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V) CITALOPRAM10 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
POVIDONE K12 (UNII: 333AG72FWJ)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code IP;52
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-288-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07728903/22/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-288)

Revised: 4/2016
Document Id: 304f1d5a-2190-51ae-e054-00144ff88e88
Set id: 304f1d5a-218f-51ae-e054-00144ff88e88
Version: 1
Effective Time: 20160412
 
DIRECT RX