Home SPL Set DailyMed Memantine Hydrochloride Extended-release Capsules Memantine Hydrochloride Extended-release Capsules SPL v5 SPL SPL Set ID ec825bef-2313-45c2-8858-b43197680155 Route ORAL Published Effective Date 2022-10-17 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Memantine (7 mg) Inactive Ingredients Ammonia Alcohol Butyl Alcohol Ethylcellulose (7 Mpa.s) Gelatin Hypromelloses Ferrosoferric Oxide Isopropyl Alcohol Potassium Hydroxide Propylene Glycol Shellac Sodium Lauryl Sulfate Sucrose Talc Triethyl Citrate Titanium Dioxide Water Fd&c Blue No. 1 Fd&c Red No. 3 Fd&c Yellow No. 6 Ferric Oxide Yellow Fd&c Blue No. 2 Identifiers & Packaging Pill Appearance Imprint: 549 Shape: capsule Color: white Color: blue Color: green Size: 14 mm Size: 16 mm Score: 1 Marketing Status ANDA Active Since 2018-04-08 Description Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts Medication Information Description Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts Package Label.principal Display Panel Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts Advanced Ingredient Data [{"name": "MEMANTINE", "unii": "W8O17SJF3T", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ALCOHOL", "unii": 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"059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:44:01.004960 · Updated: 2026-03-14T22:18:26.158923