COLESTIPOL HYDROCHLORIDE- colestipol hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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Colestipol Hydrochloride Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colestipol hydrochloride tablets, 1 g

120 tablets

NDC 70771-1653-7

Rx only

label
COLESTIPOL HYDROCHLORIDE 
colestipol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1653
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COLESTIPOL HYDROCHLORIDE (UNII: X7D10K905G) (COLESTIPOL - UNII:K50N755924) COLESTIPOL HYDROCHLORIDE1 g
Inactive Ingredients
Ingredient NameStrength
CELLACEFATE (UNII: F2O5O2OI9F)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (light yellow to yellow) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code CZ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1653-7120 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2022
2NDC:70771-1653-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21522305/04/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1653) , MANUFACTURE(70771-1653)

Revised: 2/2024
Document Id: 48ad12fb-681e-4aa7-97b3-93730856006e
Set id: 3b451f0b-5bd9-419a-afa2-a02eb0bbc45e
Version: 4
Effective Time: 20240219
 
Zydus Lifesciences Limited