Home SPL Set DailyMed Lamotrigine Extended-release Tablets Lamotrigine Extended-release Tablets SPL v5 SPL SPL Set ID ecb7a528-699f-4e51-9887-dee60456da2f Route ORAL Published Effective Date 2023-09-26 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Lamotrigine (25 mg) Inactive Ingredients D&c Yellow No. 10 Ferric Oxide Red Ferric Oxide Yellow Glyceryl Monostearate Hypromelloses Lactose Monohydrate Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Polyethylene Glycol, Unspecified Polysorbate 80 Triethyl Citrate Titanium Dioxide Water Fd&c Blue No. 2 D&c Red No. 27 Ferrosoferric Oxide Carminic Acid Identifiers & Packaging Pill Appearance Imprint: 984 Shape: round Shape: oval Color: yellow Color: green Color: orange Color: blue Color: purple Color: gray Size: 9 mm Size: 10 mm Size: 16 mm Score: 1 Marketing Status ANDA Active Since 2020-05-14 Description NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets Medication Information Description NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets Package Label.principal Display Panel NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 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Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:44:01.005942 · Updated: 2026-03-14T22:18:26.158923