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United States · US · US:72205-337_676907d3-b374-4baa-8422-c04706409540
Ivabradine
In shortageOrange BookUNIISPLATC C01EB17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01EB17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117220533718180 TABLET, FILM COATED in 1 BOTTLE (72205-337-18)
- ndc11722053376060 TABLET, FILM COATED in 1 BOTTLE (72205-337-60)
Annotations
UNII (FDA Substance ID)
TP19837BZK
IVABRADINE HYDROCHLORIDE
RxCUI 1649479
Orange Book
A213483
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ivabradine Solution
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": "72205-337_676907d3-b374-4baa-8422-c04706409540",
"productndc": "72205-337",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213483",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Apr 28, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Apr 28, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IVABRADINE HYDROCHLORIDE",
"shortage_reason": "Ivabradine Solution",
"shortage_status": "current",
"proprietary_name": "Ivabradine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213483",
"marketing_category": "ANDA",
"nonproprietary_name": "Ivabradine",
"start_marketing_date": "20250428",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code C01EB17.
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