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NDC 55513-0800-99 Corlanor 5 mg/1 Details
Corlanor 5 mg/1
Corlanor is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is IVABRADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Ivabradine is used to treat certain adults with heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) to decrease the risk that their condition will worsen and need to be treated in a hospital. It is also used to treat a certain type of heart failure in children 6 months of age and older due to cardiomyopathy (a condition in which the heart muscle becomes weakened and enlarged). Ivabradine is in a class of medications called hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blockers. It works by slowing the heart rate so the heart can pump more blood through the body each time it beats.
Related Packages: 55513-0800-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ivabradine
Product Information
| NDC | 55513-0800 |
|---|---|
| Product ID | 55513-800_9f7f886a-6d34-48f7-9f13-a34e315aeafe |
| Associated GPIs | 40700035100320 |
| GCN Sequence Number | 060186 |
| GCN Sequence Number Description | ivabradine HCl TABLET 5 MG ORAL |
| HIC3 | A2B |
| HIC3 Description | HEART RATE REDUCING,SA SELECTIVE I(F) CURRENT INH. |
| GCN | 26238 |
| HICL Sequence Number | 033396 |
| HICL Sequence Number Description | IVABRADINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Corlanor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ivabradine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | IVABRADINE HYDROCHLORIDE |
| Labeler Name | Amgen Inc |
| Pharmaceutical Class | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA206143 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0800-99 (55513080099)
| NDC Package Code | 55513-800-99 |
|---|---|
| Billing NDC | 55513080099 |
| Package | 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) |
| Marketing Start Date | 2015-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |