IVABRADINE

In shortageOrange BookUNIISPLATC C01EB17

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC01EB17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074236360
60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60)

Annotations

UNII (FDA Substance ID)

TP19837BZK

IVABRADINE HYDROCHLORIDE

RxCUI 1649479

Orange Book

A214051

ABAB

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": {
    "5157767b-16d5-4a69-b6bd-95d360d19fda": {
      "match": "brand_token",
      "title": "IVABRADINE TABLET, FILM COATED [NORTHSTAR RX LLC]",
      "spl_version": "3",
      "published_date": "2026-04-27"
    }
  },
  "productid": "50742-363_6d23c13f-f81d-4bc9-9ded-be94c025e8f7",
  "productndc": "50742-363",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214051",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 2021"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 7.5MG BASE",
        "product_no": "002",
        "approval_date": "Dec 30, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVABRADINE HYDROCHLORIDE",
  "shortage_reason": "Ivabradine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "IVABRADINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214051",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IVABRADINE",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code C01EB17.

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