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United States · US · US:46708-679_51ac7345-3188-4382-ab1d-9120d6c88927
Ivabradine
In shortageOrange BookUNIISPLATC C01EB17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC01EB17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114670867945180 TABLET, FILM COATED in 1 BOTTLE (46708-679-45)
- ndc11467086796060 TABLET, FILM COATED in 1 BOTTLE (46708-679-60)
Annotations
UNII (FDA Substance ID)
TP19837BZK
IVABRADINE HYDROCHLORIDE
RxCUI 1649479
Orange Book
A215238
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": "46708-679_51ac7345-3188-4382-ab1d-9120d6c88927",
"productndc": "46708-679",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215238",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Nov 8, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Nov 8, 2024"
}
],
"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": "ANDA215238",
"marketing_category": "ANDA",
"nonproprietary_name": "Ivabradine",
"start_marketing_date": "20241220",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C01EB17.
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