FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Granules India Limited

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Fexofenadine HCl Tablets USP, 180 mg (Gel Caps)

62207-623-97

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-623
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
AMMONIA (UNII: 5138Q19F1X)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorgray (White band in the middle) Scoreno score
ShapeOVAL (capsule shaped tablet) Size20mm
FlavorImprint Code G18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-623-9740000 in 1 DRUM11/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only11/27/2023
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-623)

Revised: 12/2023
Document Id: 0bbdb9cb-030c-2ac8-e063-6294a90a8d9a
Set id: 0adf9bea-5858-8639-e063-6394a90aa5a1
Version: 2
Effective Time: 20231205
 
Granules India Limited