Corlanor

In shortageOrange BookUNIISPLATC C01EB17

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmgen Inc

CountryUS (United States)

ATC codeC01EB17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5551381060
60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60)

Annotations

UNII (FDA Substance ID)

TP19837BZK

IVABRADINE HYDROCHLORIDE

RxCUI 1649479

Orange Book

N206143

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Ivabradine Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "TP19837BZK",
    "rxcui": "1649479",
    "inchikey": "HLUKNZUABFFNQS-ZMBIFBSDSA-N",
    "display_name": "IVABRADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "92018a65-38f6-45f7-91d4-a34921b81d0d": {
      "match": "brand_token",
      "title": "CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC]",
      "spl_version": "33",
      "published_date": "2025-11-17"
    }
  },
  "productid": "55513-810_8ab000cd-0258-489a-b1bb-4cc1ca359d6c",
  "productndc": "55513-810",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206143",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 15, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 7.5MG BASE",
        "product_no": "002",
        "approval_date": "Apr 15, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVABRADINE HYDROCHLORIDE",
  "shortage_reason": "Ivabradine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Corlanor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206143",
  "marketing_category": "NDA",
  "nonproprietary_name": "ivabradine",
  "start_marketing_date": "20150420",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code C01EB17.

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