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United States · US · US:50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e

Bisoprolol Fumarate

Orange BookUNIISPLATC C07AB07

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

Identification

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

Packs · 1

  • ndc11
    5026812715
    50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)

Annotations

UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A077910
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": "50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e",
  "productndc": "50268-127",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077910",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 27, 2006"
      }
    ],
    "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": "ANDA077910",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol Fumarate",
  "start_marketing_date": "20220110",
  "active_numerator_strength": "5"
}

Related drugs

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