Home NDC 55513-800 Corlanor
Product NDC 55513-800
11-digit product format 555130800
Labeler code 55513
Product ID 55513-800_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ivabradine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amgen Inc
Application NDA206143
Marketing category NDA
Marketing start 2015-04-20
Substance IVABRADINE HYDROCHLORIDE
Active strength 5 mg/1
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 · 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.
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# 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/1
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55513-800-60 Corlanor 60 in 1 BOTTLE TABLET, FILM COATED 60 33 55513-800-99 Corlanor 14 in 1 BOTTLE TABLET, FILM COATED 14 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 55513-800 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55513-800-60 55513080060 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) 2015-04-20 0000-00-00 No No Current 55513-800-80 55513080080 180 TABLET, FILM COATED in 1 BOTTLE (55513-800-80) 2015-04-20 0000-00-00 No No Current 55513-800-99 55513080099 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) 2015-04-20 0000-00-00 Yes No Current