Home SPL Set DailyMed SPL v1 SPL SPL Set ID 245898e5-3a61-4d6a-8375-8b3a8b7364ac Route ORAL Published Effective Date 2025-06-04 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Isotretinoin (10 mg) Inactive Ingredients Ferric Oxide Yellow Ferrosoferric Oxide Gelatin Peg-32 Hydrogenated Palm Glycerides Potassium Hydroxide Propyl Gallate Propylene Glycol Shellac Sorbitan Monooleate Soybean Oil Titanium Dioxide Water D&c Yellow No. 10 Fd&c Red No. 40 Fd&c Blue No. 1 Fd&c Red No. 3 Ferric Oxide Red Identifiers & Packaging Pill Appearance Imprint: 1579 Shape: capsule Color: yellow Color: orange Color: green Color: brown Color: blue Color: pink Size: 18 mm Size: 22 mm Size: 24 mm Score: 1 Marketing Status ANDA Active Since 2025-06-09 Description NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only Medication Information Description NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only Package Label.principal Display Panel NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only Advanced Ingredient Data [{"name": "ISOTRETINOIN", "unii": "EH28UP18IF", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": 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