Bisoprolol Fumarate

Orange BookUNIISPLATC C07AB07

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

Identification

ManufacturerTruPharma LLC

CountryUS (United States)

ATC codeC07AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5281726830
30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A075643

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": "52817-268_32f899b9-1d84-7c3d-e063-6394a90a502c",
  "productndc": "52817-268",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075643",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 16, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "003",
        "approval_date": "Mar 7, 2025"
      }
    ],
    "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": "ANDA075643",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol Fumarate",
  "start_marketing_date": "20250307",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code C07AB07.

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