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United States · US · US:70095-020_6ce4dc4f-ad08-424e-b90d-400de0b7050a

BISOPROLOL FUMARATE

Orange BookUNIISPLATC C07AB07

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

Identification

ManufacturerSun Pharmaceutical Industries Limited
CountryUS (United States)
ATC codeC07AB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7009502001
    30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-020-01)
  • ndc11
    7009502002
    100 TABLET, FILM COATED in 1 BOTTLE (70095-020-02)

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": "70095-020_6ce4dc4f-ad08-424e-b90d-400de0b7050a",
  "productndc": "70095-020",
  "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": "5"
}

Related drugs

Other records sharing ATC code C07AB07.

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