Home SPL Set DailyMed Sirolimus Tablets Sirolimus Tablets SPL v11 SPL SPL Set ID 82562b68-224d-482a-b399-a89b81d5eb31 Route ORAL Published Effective Date 2023-09-27 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Sirolimus (0.5 mg) Inactive Ingredients Alpha-tocopherol Acetate Cellulose, Microcrystalline Citric Acid Monohydrate Crospovidone (15 Mpa.s At 5%) Fd&c Yellow No. 5 Ferric Oxide Yellow Glyceryl Oleate Hypromelloses Lactose Monohydrate Poloxamer 188 Polyethylene Glycol, Unspecified Povidone Sucrose Talc Titanium Dioxide Crospovidone (120 .mu.m) Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 3350 Polyethylene Glycol 6000 Povidone K30 Ferric Oxide Red Polyethylene Glycol 8000 Identifiers & Packaging Pill Appearance Imprint: 21 Shape: round Color: yellow Color: white Size: 5 mm Size: 7 mm Size: 9 mm Score: 1 Marketing Status ANDA Active Since 2023-02-16 Description Sirolimus Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only Medication Information Description Sirolimus Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only Package Label.principal Display Panel Sirolimus Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) Sirolimus Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only Advanced Ingredient Data [{"name": "SIROLIMUS", "unii": "W36ZG6FT64", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": 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Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:39:00.099174 · Updated: 2026-03-14T21:56:18.712126
