corlanor

Generic: ivabradine

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name corlanor
Generic Name ivabradine
Labeler amgen inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 7.5 mg/1

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-810
Product ID 55513-810_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206143
Listing Expiration 2026-12-31
Marketing Start 2015-04-20

Pharmacologic Class

Classes
hyperpolarization-activated cyclic nucleotide-gated channel antagonists [moa] hyperpolarization-activated cyclic nucleotide-gated channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513810
Hyphenated Format 55513-810

Supplemental Identifiers

RxCUI
1649485 1649491 1649493 1649495 2168592 2168596
UPC
0355513800600 0355513810609
UNII
TP19837BZK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name corlanor (source: ndc)
Generic Name ivabradine (source: ndc)
Application Number NDA206143 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60)
source: ndc

Packages (1)

55513-810-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60)

Ingredients (1)

ivabradine hydrochloride (7.5 mg/1)

Linked Drug Pages (1)

Corlanor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ab000cd-0258-489a-b1bb-4cc1ca359d6c", "openfda": {"upc": ["0355513800600", "0355513810609"], "unii": ["TP19837BZK"], "rxcui": ["1649485", "1649491", "1649493", "1649495", "2168592", "2168596"], "spl_set_id": ["92018a65-38f6-45f7-91d4-a34921b81d0d"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60)", "package_ndc": "55513-810-60", "marketing_start_date": "20150420"}], "brand_name": "Corlanor", "product_id": "55513-810_8ab000cd-0258-489a-b1bb-4cc1ca359d6c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]", "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]"], "product_ndc": "55513-810", "generic_name": "ivabradine", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Corlanor", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "NDA206143", "marketing_category": "NDA", "marketing_start_date": "20150420", "listing_expiration_date": "20261231"}