🇺🇸
United States · US · US:69452-191_2eacec81-3528-a573-e063-6394a90a6da4
ivabradine
In shortageOrange BookUNIISPLATC C01EB17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeC01EB17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11694521911760 TABLET, FILM COATED in 1 BOTTLE (69452-191-17)
- ndc116945219130500 TABLET, FILM COATED in 1 BOTTLE (69452-191-30)
Annotations
UNII (FDA Substance ID)
TP19837BZK
IVABRADINE HYDROCHLORIDE
RxCUI 1649479
Orange Book
A213276
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": "69452-191_2eacec81-3528-a573-e063-6394a90a6da4",
"productndc": "69452-191",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213276",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Sep 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Sep 5, 2024"
}
],
"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": "ANDA213276",
"marketing_category": "ANDA",
"nonproprietary_name": "ivabradine",
"start_marketing_date": "20250301",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code C01EB17.
Access this data programmatically
Query ivabradine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.