Home SPL Set DailyMed Labetalol Hydrochloride Tablets, Usp Labetalol Hydrochloride Tablets, Usp SPL v6 SPL SPL Set ID a3c0cc1e-1c01-4009-afdc-d35a66546aec Route ORAL Published Effective Date 2022-10-17 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Labetalol (100 mg) Inactive Ingredients Aluminum Oxide D&c Yellow No. 10 Ferric Oxide Red Ferric Oxide Yellow Hypromelloses Lactose Monohydrate Magnesium Stearate Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Talc Titanium Dioxide Fd&c Blue No. 1--aluminum Lake Identifiers & Packaging Pill Appearance Imprint: 800 Shape: round Color: yellow Color: white Color: green Size: 8 mm Size: 11 mm Score: 1 Marketing Status ANDA Active Since 2017-12-05 Description NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Medication Information Description NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Package Label.principal Display Panel NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Advanced Ingredient Data [{"name": "LABETALOL", "unii": "R5H8897N95", "classCode": "ACTIB", 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Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:44:00.851980 · Updated: 2026-03-14T22:18:26.158923
