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United States · US · US:71335-2244_b77f45b2-ce63-417b-abdb-e6f807c1ec6c

Bisoprolol Fumarate

Orange BookUNIISPLATC C07AB07

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

Identification

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

Packs · 4

  • ndc11
    7133522441
    30 TABLET in 1 BOTTLE, PLASTIC (71335-2244-1)
  • ndc11
    7133522442
    120 TABLET in 1 BOTTLE, PLASTIC (71335-2244-2)
  • ndc11
    7133522443
    180 TABLET in 1 BOTTLE, PLASTIC (71335-2244-3)
  • ndc11
    7133522444
    90 TABLET in 1 BOTTLE, PLASTIC (71335-2244-4)

Annotations

UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A078635
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": "71335-2244_b77f45b2-ce63-417b-abdb-e6f807c1ec6c",
  "productndc": "71335-2244",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078635",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 18, 2009"
      }
    ],
    "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": "ANDA078635",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol fumarate",
  "start_marketing_date": "20090921",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C07AB07.

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