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United States · US · US:70954-455_6517d564-ea55-4084-a8ab-34fea548c24e
Bisoprolol Fumarate
Orange BookUNIISPLATC C07AB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovitium Pharma LLC
CountryUS (United States)
ATC codeC07AB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11709544551030 TABLET in 1 BOTTLE (70954-455-10)
- ndc117095445520100 TABLET in 1 BOTTLE (70954-455-20)
Annotations
UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A215563
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UR59KN573L",
"rxcui": "142146",
"inchikey": "VMDFASMUILANOL-WXXKFALUSA-N",
"display_name": "BISOPROLOL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c3ee566c-74c4-45f4-a947-526a7313e326": {
"match": "brand_token",
"title": "BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED [MICRO LABS LIMITED]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "70954-455_6517d564-ea55-4084-a8ab-34fea548c24e",
"productndc": "70954-455",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215563",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Oct 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 29, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BISOPROLOL FUMARATE",
"proprietary_name": "Bisoprolol Fumarate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215563",
"marketing_category": "ANDA",
"nonproprietary_name": "Bisoprolol Fumarate",
"start_marketing_date": "20211029",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AB07.
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