SEVELAMER CARBONATE - sevelamer carbonate tablet, film coated 
Zydus Lifesciences Limited

----------

Sevelamer Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1520-8

Sevelamer Tablets, 800 mg

270  Tablets

Rx only

label
SEVELAMER CARBONATE 
sevelamer carbonate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1520
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C) SEVELAMER CARBONATE800 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIACETIN (UNII: XHX3C3X673)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off-white to pale yellow) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size20mm
FlavorImprint Code 824
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1520-8270 in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
2NDC:70771-1520-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
3NDC:70771-1520-410 in 1 CARTON09/17/2020
3NDC:70771-1520-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775909/17/2020
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1520) , MANUFACTURE(70771-1520)

Revised: 10/2022
Document Id: 166472cf-5039-4c67-8cde-2a4c13907fa3
Set id: cbdee883-ccc7-4c55-965d-b608a214b375
Version: 2
Effective Time: 20221031
 
Zydus Lifesciences Limited