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 SOLUTION
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 5 mg/5mL

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-813
Product ID 55513-813_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209964
Listing Expiration 2026-12-31
Marketing Start 2019-04-19

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 55513813
Hyphenated Format 55513-813

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 NDA209964 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01)
source: ndc

Packages (1)

55513-813-28 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01)

Ingredients (1)

ivabradine hydrochloride (5 mg/5mL)

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": "28 AMPULE in 1 CARTON (55513-813-28)  / 5 mL in 1 AMPULE (55513-813-01)", "package_ndc": "55513-813-28", "marketing_start_date": "20190419"}], "brand_name": "Corlanor", "product_id": "55513-813_8ab000cd-0258-489a-b1bb-4cc1ca359d6c", "dosage_form": "SOLUTION", "pharm_class": ["Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]", "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]"], "product_ndc": "55513-813", "generic_name": "ivabradine", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Corlanor", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA209964", "marketing_category": "NDA", "marketing_start_date": "20190419", "listing_expiration_date": "20261231"}