Bisoprolol Fumarate

Orange BookUNIISPLATC C07AB07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovitium Pharma LLC

CountryUS (United States)

ATC codeC07AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7095445610
30 TABLET in 1 BOTTLE (70954-456-10)
ndc11
7095445620
100 TABLET in 1 BOTTLE (70954-456-20)

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": "70954-456_6517d564-ea55-4084-a8ab-34fea548c24e",
  "productndc": "70954-456",
  "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": "10"
}

Related drugs

Other records sharing ATC code C07AB07.

Access this data programmatically

Query Bisoprolol Fumarate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs