Label: COLESTIPOL HYDROCHLORIDE tablet, film coated
- NDC Code(s): 70771-1653-5, 70771-1653-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2024
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INGREDIENTS AND APPEARANCE
COLESTIPOL HYDROCHLORIDE
colestipol hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1653 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLESTIPOL HYDROCHLORIDE (UNII: X7D10K905G) (COLESTIPOL - UNII:K50N755924) COLESTIPOL HYDROCHLORIDE 1 g Inactive Ingredients Ingredient Name Strength CELLACEFATE (UNII: F2O5O2OI9F) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (light yellow to yellow) Score no score Shape OVAL Size 20mm Flavor Imprint Code CZ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1653-7 120 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2022 2 NDC:70771-1653-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215223 05/04/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1653) , MANUFACTURE(70771-1653)
