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United States · US · US:72578-111_d47ca4c0-7783-43d1-a951-5adca27ea13c

Bisoprolol Fumarate

Orange BookUNIISPLATC C07AB07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeC07AB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7257811101
    100 TABLET, FILM COATED in 1 BOTTLE (72578-111-01)
  • ndc11
    7257811106
    30 TABLET, FILM COATED in 1 BOTTLE (72578-111-06)

Annotations

UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A215680
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": "72578-111_d47ca4c0-7783-43d1-a951-5adca27ea13c",
  "productndc": "72578-111",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215680",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2022"
      }
    ],
    "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": "ANDA215680",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol Fumarate",
  "start_marketing_date": "20220915",
  "active_numerator_strength": "5"
}

Related drugs

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