COLESTIPOL HYDROCHLORIDE tablet, film coated

Colestipol hydrochloride by

Drug Labeling and Warnings

Colestipol hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colestipol hydrochloride tablets, 1 g

120 tablets

NDC: 70771-1653-7

Rx only

INGREDIENTS AND APPEARANCE

COLESTIPOL HYDROCHLORIDE 
colestipol hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1653
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COLESTIPOL HYDROCHLORIDE (UNII: X7D10K905G) (COLESTIPOL - UNII:K50N755924)	COLESTIPOL HYDROCHLORIDE	1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (light yellow to yellow)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	CZ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1653-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2022
2	NDC: 70771-1653-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215223	05/04/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1653) , MANUFACTURE(70771-1653)