Label: IVABRADINE tablet
- NDC Code(s): 70771-1863-6, 70771-1863-8, 70771-1864-6, 70771-1864-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 1, 2023
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INGREDIENTS AND APPEARANCE
IVABRADINE
ivabradine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1863 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ) IVABRADINE 5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code 1471 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1863-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2024 2 NDC:70771-1863-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213442 07/02/2024 IVABRADINE
ivabradine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1864 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ) IVABRADINE 7.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape ROUND Size 7mm Flavor Imprint Code 1472 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1864-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2024 2 NDC:70771-1864-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213442 07/02/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1863, 70771-1864) , MANUFACTURE(70771-1863, 70771-1864)
