Corlanor

Product NDC: 70518-3309
11-digit product format: 705183309
Labeler code: 70518
Product ID: 70518-3309_d426af55-fab2-df0a-e053-2a95a90a197b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ivabradine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA206143
Marketing category: NDA
Marketing start: 2021-12-24
Marketing end: 0000-00-00
Substance: IVABRADINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC],Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-3309		D	Discontinued by firm		2026-08-11
excluded package	package	70518-3309	70518-3309-0	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3309-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3309-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3309-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3309-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3309-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3309-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3309-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3309-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3309-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3309-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3309-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3309-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N206143-001	CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15
N206143-002	CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL		RLD	2015-04-15

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7361649*PED	2026-08-22		Pediatric extension
N206143-001	7361650*PED	2026-08-22		Pediatric extension
N206143-001	7879842*PED	2026-08-22		Pediatric extension
N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7867996*PED	2027-06-12		Pediatric extension
N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7361649*PED	2026-08-22		Pediatric extension
N206143-002	7361650*PED	2026-08-22		Pediatric extension
N206143-002	7879842*PED	2026-08-22		Pediatric extension
N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7867996*PED	2027-06-12		Pediatric extension

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD	2015-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206143-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206143-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206143-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206143-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206143-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206143-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206143-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N206143-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206143-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N206143-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206143-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206143-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206143-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206143-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206143-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206143-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206143-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206143-002	AB	1	`3f0d92c62455…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 656 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361649*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361650*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7879842*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7867996*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361649*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361650*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7879842*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7867996*PED	2027-06-12		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206143-001	NCE	2020-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-001	PED	2020-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	NCE	2020-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	PED	2020-10-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206143-001	NCE	2020-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-001	PED	2020-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-002	NCE	2020-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-002	PED	2020-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206143-001	NCE	2020-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-001	PED	2020-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-002	NCE	2020-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-002	PED	2020-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206143-001	NCE	2020-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-001	PED	2020-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-002	NCE	2020-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-002	PED	2020-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206143-001	NCE	2020-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-001	PED	2020-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-002	NCE	2020-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-002	PED	2020-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206143-001	NCE	2020-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-001	PED	2020-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-002	NCE	2020-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-002	PED	2020-10-15	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3309-0	2023-03-24	C162847	48780-1	f386c64a-1313-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CORLANOR safely and effectively. See full prescribing information for CORLANOR . CORLANOR ® ( ivabradine ) t ablets , for oral use CORLANOR ® (ivabradine) oral solution Initial U.S. Approval: 2015
70518-3309-0	2023-01-30	C162847	48780-1	f386c64a-1313-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CORLANOR safely and effectively. See full prescribing information for CORLANOR . CORLANOR ® ( ivabradine ) t ablets , for oral use CORLANOR ® (ivabradine) oral solution Initial U.S. Approval: 2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3309-0	EA - Each	70518-3309	d9d9b76a-915c-4cf1-9dcb-4f9f8b4aeb6a	1	2024-05-16

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
Corlanor	IVABRADINE	Amgen Inc	92018a65-38f6-45f7-91d4-a34921b81d0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206143 application number: NDA206143

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TP19837BZK	IVABRADINE HYDROCHLORIDE	148849-67-6	IVABRADINE HYDROCHLORIDE
3H48L0LPZQ	IVABRADINE	155974-00-8	ivabradine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3309-0	70518330900	28 TABLET, FILM COATED in 1 BLISTER PACK (70518-3309-0)	2021-12-24	0000-00-00	No	No	Current