Corlanor

Product NDC: 55513-813
Requested package NDC: 55513-813-28
11-digit product format: 555130813
Labeler code: 55513
Product ID: 55513-813_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ivabradine
Dosage form: SOLUTION
Route: ORAL
Labeler: Amgen Inc
Application: NDA209964
Marketing category: NDA
Marketing start: 2019-04-19
Substance: IVABRADINE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209964-001	CORLANOR	IVABRADINE	5MG/5ML (1MG/ML)	SOLUTION / ORAL		RLD	2019-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03
N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03
N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03
N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209964-001	ODE-234	2026-04-22
N209964-001	PED	2026-10-22

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209964-001	CORLANOR	5MG/5ML (1MG/ML)	SOLUTION / ORAL	RLD, RS	2019-04-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209964-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209964-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209964-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2019-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209964-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2019-05-03	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209964-001	ODE-234	2026-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209964-001	PED	2026-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	ODE-234	2026-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209964-001	PED	2026-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209964-001	ODE-234	2026-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209964-001	PED	2026-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	ODE-234	2026-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209964-001	PED	2026-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	ODE-234	2026-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209964-001	PED	2026-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	ODE-234	2026-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209964-001	PED	2026-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	ODE-234	2026-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209964-001	PED	2026-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	ODE-234	2026-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209964-001	PED	2026-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	ODE-234	2026-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209964-001	PED	2026-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209964-001	ODE-234	2026-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209964-001	PED	2026-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209964-001	ODE-234	2026-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209964-001	PED	2026-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209964-001	ODE-234	2026-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209964-001	PED	2026-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209964-001	ODE-234	2026-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209964-001	PED	2026-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209964-001	ODE-234	2026-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209964-001	PED	2026-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209964-001	NP	2022-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209964-001	PED	2022-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209964-001	ODE-234	2026-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209964-001	PED	2026-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209964-001	NP	2022-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209964-001	PED	2022-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209964-001	ODE-234	2026-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209964-001	PED	2026-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209964-001	NP	2022-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209964-001	PED	2022-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209964-001	ODE-234	2026-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209964-001	PED	2026-10-22	`4b0b4de00fa7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Corlanor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IVABRADINE HYDROCHLORIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TP19837BZK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1649485	Internal RxNorm lookup
1649491	Internal RxNorm lookup
1649493	Internal RxNorm lookup
1649495	Internal RxNorm lookup
2168592	Internal RxNorm lookup
2168596	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92018a65-38f6-45f7-91d4-a34921b81d0d	Available on FDA.report

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	Strength	SPL version
55513-813-01	Corlanor	5 mL in 1 AMPULE	SOLUTION	5		33
55513-813-28	Corlanor	28 in 1 CARTON	SOLUTION	28		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-813-01	ML - Milliliter	55513-813	d0566713-5f02-441a-8042-b3b57ee58b8f	1	2019-09-05
55513-813-28	ML - Milliliter	55513-813	76d80b3c-6146-4d32-9122-f58f17b84997	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IVABRADINE HYDROCHLORIDE	ACTIVE INGREDIENT	TP19837BZK	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
IVABRADINE	ACTIVE MOIETY	3H48L0LPZQ	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-813	CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC]	31	Current NDC, Legacy NDC, 2 package rows	20230615_92018a65-38f6-45f7-91d4-a34921b81d0d.zip

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): 209964 application number: NDA209964 ndc (package): 55513-813-28 ndc (product): 55513-813 ndc11 (package): 55513081328

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2168596	Corlanor 5 MG in 5 mL Oral Solution	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649491	Corlanor 5 MG Oral Tablet	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649495	Corlanor 7.5 MG Oral Tablet	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168592	ivabradine 5 MG in 5 mL Oral Solution	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649485	ivabradine 5 MG Oral Tablet	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649493	ivabradine 7.5 MG Oral Tablet	PSN	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168596	ivabradine 1 MG/ML Oral Solution [Corlanor]	SBD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649491	ivabradine 5 MG Oral Tablet [Corlanor]	SBD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649495	ivabradine 7.5 MG Oral Tablet [Corlanor]	SBD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168592	ivabradine 1 MG/ML Oral Solution	SCD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649485	ivabradine 5 MG Oral Tablet	SCD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649493	ivabradine 7.5 MG Oral Tablet	SCD	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168596	Corlanor 1 MG/ML Oral Solution	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649491	Corlanor 5 MG (as ivabradine HCl 5.39 MG) Oral Tablet	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168596	Corlanor 5 MG per 5 ML (as ivabradine HCl 5.39 MG) Oral Solution	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649495	Corlanor 7.5 MG (as ivabradine HCl 8.085 MG) Oral Tablet	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649485	ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral Tablet	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
2168592	ivabradine 5 MG per 5 ML (as ivabradine HCl 5.39 MG) Oral Solution	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33
1649493	ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral Tablet	SY	92018a65-38f6-45f7-91d4-a34921b81d0d	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-813-28	55513081328	28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01)	28 ampule	2019-04-19	0000-00-00	No	No	Current