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United States · US · US:62332-603_918dc4a5-ef02-4ab0-8664-7c02b23e37b6

BISOPROLOL FUMARATE

Orange BookUNIISPLATC C07AB07

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC07AB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6233260330
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-603-30)
  • ndc11
    6233260331
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-603-31)
  • ndc11
    6233260371
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-603-71)

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": "62332-603_918dc4a5-ef02-4ab0-8664-7c02b23e37b6",
  "productndc": "62332-603",
  "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": "5"
}

Related drugs

Other records sharing ATC code C07AB07.

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