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United States · US · US:43547-617_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2
Bisoprolol fumarate
Orange BookUNIISPLATC C07AB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeC07AB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11435476170330 TABLET in 1 BOTTLE (43547-617-03)
- ndc114354761710100 TABLET in 1 BOTTLE (43547-617-10)
- ndc114354761750500 TABLET in 1 BOTTLE (43547-617-50)
Annotations
UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A217368
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": "43547-617_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2",
"productndc": "43547-617",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217368",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 14, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 14, 2023"
}
],
"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": "ANDA217368",
"marketing_category": "ANDA",
"nonproprietary_name": "Bisoprolol fumarate",
"start_marketing_date": "20220705",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AB07.
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