Label: FEXOFENADINE HYDROCHLORIDE tablet
- NDC Code(s): 62207-623-97
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 5, 2023
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tabletProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-623 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength 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 Color gray (White band in the middle) Score no score Shape OVAL (capsule shaped tablet) Size 20mm Flavor Imprint Code G18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-623-97 40000 in 1 DRUM 11/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 11/27/2023 Labeler - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 manufacture(62207-623)