BISOPROLOL FUMARATE

Orange BookUNIISPLATC C07AB07

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC07AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278939582
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-395-82)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A217617

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": "72789-395_31f67825-d007-651f-e063-6394a90abab8",
  "productndc": "72789-395",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217617",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 18, 2024"
      }
    ],
    "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": "ANDA217617",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BISOPROLOL FUMARATE",
  "start_marketing_date": "20240310",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C07AB07.

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