BISOPROLOL FUMARATE

Orange BookUNIISPLATC C07AB07

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeC07AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4670860430
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-604-30)
ndc11
4670860431
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-604-31)
ndc11
4670860471
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-604-71)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A204891

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": "46708-604_ae10b8e1-557d-4437-8a1d-89d7844122c8",
  "productndc": "46708-604",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204891",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 11, 2017"
      }
    ],
    "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": "ANDA204891",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BISOPROLOL FUMARATE",
  "start_marketing_date": "20190911",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C07AB07.

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