Home SPL Set DailyMed Colesevelam Hydrochloride Tablets Colesevelam Hydrochloride Tablets SPL v5 SPL SPL Set ID 090eabd5-acd3-43ed-a05b-52f1f3773a93 Route ORAL Published Effective Date 2022-08-12 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Colesevelam (625 mg) Inactive Ingredients Ammonia Butyl Alcohol Cellulose, Microcrystalline Crospovidone Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Hypromellose, Unspecified Isopropyl Alcohol Magnesium Stearate Methacrylic Acid Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone Propylene Glycol Shellac Silicon Dioxide Sodium Bicarbonate Talc Titanium Dioxide Identifiers & Packaging Pill Appearance Imprint: 619 Shape: capsule Color: yellow Size: 20 mm Score: 1 Marketing Status ANDA Active Since 2019-10-11 Description Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only Medication Information Description Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only Package Label.principal Display Panel Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only Advanced Ingredient Data [{"name": "COLESEVELAM", "unii": "1XU104G55N", "classCode": "ACTIB", "strengthNumerator": "625", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ALCOHOL", "unii": "8PJ61P6TS3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": 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"strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID", "unii": "1CS02G8656", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:57.990463 · Updated: 2026-03-14T22:18:18.443233