ivabradine by Zydus Lifesciences Limited IVABRADINE tablet

ivabradine by

Drug Labeling and Warnings

ivabradine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ivabradine Tablets, 5 mg

NDC: 70771-1863-6

60 tablets

Rx only

Ivabradine Tablets, 5 mg

NDC: 70771-1864-6

60 tablets

Rx only

INGREDIENTS AND APPEARANCE

IVABRADINE 
ivabradine tablet

Product 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 tablet

Product 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)