Home SPL Set DailyMed Lubiprostone Capsules Lubiprostone Capsules SPL v2 SPL SPL Set ID 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9 Route ORAL Published Effective Date 2023-03-24 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Lubiprostone (8 ug) Inactive Ingredients 1,4-sorbitan Ferric Oxide Red Ferrosoferric Oxide Gelatin, Unspecified Medium-chain Triglycerides Propylene Glycol Shellac Sorbitol Titanium Dioxide Water Identifiers & Packaging Pill Appearance Imprint: 24 Shape: oval Color: pink Color: yellow Size: 9 mm Score: 1 Marketing Status ANDA Active Since 2023-03-23 Description NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only Medication Information Description NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only Package Label.principal Display Panel NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only Advanced Ingredient Data [{"name": "LUBIPROSTONE", "unii": "7662KG2R6K", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "1,4-SORBITAN", "unii": "AV0YTZ4E6J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LUBIPROSTONE", "unii": "7662KG2R6K", "classCode": "ACTIB", "strengthNumerator": "24", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "1,4-SORBITAN", "unii": "AV0YTZ4E6J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:59.641007 · Updated: 2026-03-14T22:18:26.158923