COLESEVELAM- colesevelam tablet 
Cadila Healthcare Limited

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COLESEVELAM HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colesevelam Hydrochloride Tablets, 625 mg

NDC 70771-1368-8

180 Tablets

Rx only

image
COLESEVELAM 
colesevelam tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1368
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COLESEVELAM HYDROCHLORIDE (UNII: P4SG24WI5Q) (COLESEVELAM - UNII:1XU104G55N) COLESEVELAM HYDROCHLORIDE625 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeCAPSULE (Modified Capsule) Size20mm
FlavorImprint Code 619
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1368-8180 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2019
2NDC:70771-1368-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2019
3NDC:70771-1368-410 in 1 CARTON10/11/2019
3NDC:70771-1368-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776510/11/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1368) , MANUFACTURE(70771-1368)

Revised: 8/2020
Document Id: 99dde734-a13d-4e37-9af7-99223416cd25
Set id: 090eabd5-acd3-43ed-a05b-52f1f3773a93
Version: 2
Effective Time: 20200818
 
Cadila Healthcare Limited