FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Granules India Limited

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Fexofenadine Hydrochloride Tablets USP

Fexofenadine Hydrochloride Tablets 60 mg

fexo-60mg-drum-label.jpg

Fexofenadine Hydrochloride Tablets 180 mg

180 mg

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-768
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE (UNII: E6582LOH6V) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Modified oval shape) Size12mm
FlavorImprint Code SG;201
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-768-8590000 in 1 DRUM; Type 0: Not a Combination Product03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/30/2018
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE (UNII: E6582LOH6V) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE60 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULE (capsule shaped) Size17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-769-8490000 in 1 DRUM; Type 0: Not a Combination Product03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/15/2018
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-768, 62207-769) , analysis(62207-768, 62207-769) , pack(62207-768, 62207-769) , label(62207-768, 62207-769)

Revised: 9/2019
Document Id: 92737d55-7f07-50d0-e053-2a95a90ac7af
Set id: 66e5016b-83fb-4f49-e053-2991aa0a0e59
Version: 2
Effective Time: 20190913
 
Granules India Limited