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United States · US · US:70710-1471_cbea8583-e207-402a-b79a-83ff14a3fa9b
ivabradine
In shortageOrange BookUNIISPLATC C01EB17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC01EB17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101471660 TABLET in 1 BOTTLE (70710-1471-6)
- ndc117071014718180 TABLET in 1 BOTTLE (70710-1471-8)
Annotations
UNII (FDA Substance ID)
TP19837BZK
IVABRADINE HYDROCHLORIDE
RxCUI 1649479
Orange Book
A213442
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": "70710-1471_cbea8583-e207-402a-b79a-83ff14a3fa9b",
"productndc": "70710-1471",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213442",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Nov 29, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Nov 29, 2023"
}
],
"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": "ANDA213442",
"marketing_category": "ANDA",
"nonproprietary_name": "ivabradine",
"start_marketing_date": "20240702",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C01EB17.
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