Home SPL Set DailyMed Candesartan Cilexetil Tablets Candesartan Cilexetil Tablets SPL v5 SPL SPL Set ID 26df3269-3682-4ce0-be81-8c029254b5a8 Route ORAL Published Effective Date 2018-02-20 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Candesartan (4 mg) Inactive Ingredients Carboxymethylcellulose Calcium Ferric Oxide Red Hydroxypropyl Cellulose (110000 Wamw) Lactose Monohydrate Magnesium Stearate Polyethylene Glycol 6000 Starch, Corn Identifiers & Packaging Pill Appearance Imprint: ZE;61 Shape: round Color: pink Color: white Size: 7 mm Size: 9 mm Score: 2 Marketing Status ANDA Active Since 2018-02-22 Description NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets Medication Information Description NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets Package Label.principal Display Panel NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets Advanced Ingredient Data [{"name": "CANDESARTAN", "unii": "S8Q36MD2XX", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOXYMETHYLCELLULOSE CALCIUM", "unii": "UTY7PDF93L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (110000 WAMW)", "unii": "5Y0974F5PW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDESARTAN", "unii": "S8Q36MD2XX", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOXYMETHYLCELLULOSE CALCIUM", "unii": "UTY7PDF93L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (110000 WAMW)", "unii": "5Y0974F5PW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDESARTAN", "unii": "S8Q36MD2XX", "classCode": "ACTIB", "strengthNumerator": "16", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOXYMETHYLCELLULOSE CALCIUM", "unii": "UTY7PDF93L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (110000 WAMW)", "unii": "5Y0974F5PW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDESARTAN", "unii": "S8Q36MD2XX", "classCode": "ACTIB", "strengthNumerator": "32", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOXYMETHYLCELLULOSE CALCIUM", "unii": "UTY7PDF93L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (110000 WAMW)", "unii": "5Y0974F5PW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:51:58.476328 · Updated: 2026-03-14T22:42:31.100661
