COLESEVELAM

COLESEVELAM- colesevelam hydrochloride tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colesevelam Hydrochloride Tablets, 625 mg

NDC 70771-1368-8

180 Tablets

Rx only

image
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COLESEVELAM
colesevelam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1368
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 625 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape CAPSULE (Modified Capsule) Size 20mm
Flavor Imprint Code 619
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1368-8 180 TABLET in 1 BOTTLE None
2 NDC:70771-1368-0 1000 TABLET in 1 BOTTLE None
3 NDC:70771-1368-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1368-2)
3 NDC:70771-1368-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1368-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207765 10/11/2019
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1368), MANUFACTURE (70771-1368)

Revised: 08/2020 Cadila Healthcare Limited

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