Ivabradine Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:18:31

Label at a glance#

Productivabradine

Active ingredientIVABRADINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1649485	ivabradine 5 MG Oral Tablet	PSN	2
1649493	ivabradine 7.5 MG Oral Tablet	PSN	2
1649485	ivabradine 5 MG Oral Tablet	SCD	2
1649493	ivabradine 7.5 MG Oral Tablet	SCD	2
1649485	ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral Tablet	SY	2
1649493	ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IVABRADINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
eebd3ed3-f483-47f1-9e64-83ee4010ac6e	Product name	5	20260130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1863-6	ivabradine	60 in 1 BOTTLE	TABLET	60	2
70771-1863-8	ivabradine	180 in 1 BOTTLE	TABLET	180	2
70771-1864-6	ivabradine	60 in 1 BOTTLE	TABLET	60	2
70771-1864-8	ivabradine	180 in 1 BOTTLE	TABLET	180	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1863	IVABRADINE TABLET [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 2 package rows	20241204_246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3.zip
70771-1864	IVABRADINE TABLET [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 2 package rows	20241204_246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

ivabradine
IVABRADINE HYDROCHLORIDE
ALUMINUM OXIDE
ANHYDROUS LACTOSE
D&C RED NO. 27 ALUMINUM LAKE
D&C YELLOW NO. 10
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1863	70771-1863-6, 70771-1863-8
70771-1864	70771-1864-6, 70771-1864-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IVABRADINE HYDROCHLORIDE	TP19837BZK	ACTIM
ALUMINUM OXIDE	LMI26O6933	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 4000	4R4HFI6D95	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IVABRADINE HYDROCHLORIDE	TP19837BZK	ACTIM
ALUMINUM OXIDE	LMI26O6933	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 4000	4R4HFI6D95	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213442-001	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2023-11-29
A213442-002	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB		2023-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213442-001	AB
A213442-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213442-001	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2023-11-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213442-002	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL	AB	2023-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213442-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213442-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213442-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213442-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213442-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213442-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213442-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213442-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213442-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213442-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213442-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213442-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213442-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213442-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213442-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213442-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213442-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213442-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213442-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213442-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213442-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213442-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213442-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213442-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213442-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213442-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213442-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213442-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213442-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213442-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213442-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213442-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213442-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213442-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213442-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213442-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213442-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213442-002	AB	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213442-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213442-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ivabradine	IVABRADINE	Zydus Lifesciences Limited	246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3	2024-11-30		Exact identifier ndc (package): 70771-1864-6 ndc (package): 70771-1864-8 ndc (package): 70771-1863-6 ndc (package): 70771-1863-8 ndc (product): 70771-1863 ndc (product): 70771-1864 ndc11 (package): 70771186308 ndc11 (package): 70771186306 ndc11 (package): 70771186408 ndc11 (package): 70771186406 spl id: b83cc3b5-db55-4fc0-a89d-2cae17fcd445 spl set id: 246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.