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![CANDESARTAN CILEXETIL TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/26df3269-3682-4ce0-be81-8c029254b5a8/76fb9700-d87f-48bc-beb9-5d83828e39ee-05.jpg)
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| NDC | 70771-1204-3, 70771-1204-5, 70771-1204-9, 70771-1205-3, 70771-1205-5, 70771-1205-9, 70771-1206-0, 70771-1206-1, 70771-1206-3, 70771-1206-5, 70771-1206-9, 70771-1207-0, 70771-1207-1, 70771-1207-3, 70771-1207-5, 70771-1207-9 |
| Set ID | 26df3269-3682-4ce0-be81-8c029254b5a8 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Angiotensin 2 Receptor Blocker |
| Product Number | |
| Application Number | ANDA091390 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CANDESARTAN CILEXETIL
candesartan cilexetil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1204 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL 4 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) FERRIC OXIDE RED (UNII: 1K09F3G675) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (LIGHT PINK) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code ZE;58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1204-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 2 NDC:70771-1204-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 3 NDC:70771-1204-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091390 02/22/2018 CANDESARTAN CILEXETIL
candesartan cilexetil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL 8 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) FERRIC OXIDE RED (UNII: 1K09F3G675) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (PINK) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code ZE;59 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1205-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 2 NDC:70771-1205-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 3 NDC:70771-1205-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091390 02/22/2018 CANDESARTAN CILEXETIL
candesartan cilexetil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1206 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL 16 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code ZE;60 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1206-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 2 NDC:70771-1206-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 3 NDC:70771-1206-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 4 NDC:70771-1206-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 5 NDC:70771-1206-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091390 02/22/2018 CANDESARTAN CILEXETIL
candesartan cilexetil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1207 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL 32 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 9mm Flavor Imprint Code ZE;61 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1207-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 2 NDC:70771-1207-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 3 NDC:70771-1207-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 4 NDC:70771-1207-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 5 NDC:70771-1207-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091390 02/22/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1204, 70771-1205, 70771-1206, 70771-1207) , MANUFACTURE(70771-1204, 70771-1205, 70771-1206, 70771-1207)
