Label: COMPRESSO GGF 95 SA- guaifenesin directly compressible granules 95% powder
COMPRESSO GGF 95 SA- guaifenesin directly compressible granules 95% powder
- NDC Code(s): 62207-500-04, 62207-503-13
- Packager: Granules India Limited
- Category: BULK INGREDIENT
Drug Label Information
Updated February 17, 2023
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INGREDIENTS AND APPEARANCE
COMPRESSO GGF 95 SA
guaifenesin directly compressible granules 95% powderProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-503 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 95 mg in 100 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white (White free flowing granular powder) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-503-13 50000000 mg in 1 DRUM 05/04/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 05/04/2012 COMPRESSO GGF 95 SA
guaifenesin directly compressible granules 95% powderProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-500 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 95 mg in 100 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white (White free flowing granular powder) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-500-04 50000000 mg in 1 DRUM 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 08/17/2017 Labeler - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 analysis(62207-503, 62207-500) , label(62207-503, 62207-500) , manufacture(62207-503, 62207-500) , pack(62207-503, 62207-500)
