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United States · US · US:72578-113_550e6ac5-3ece-461f-a9c5-2e4050a5eabb

Bisoprolol Fumarate and Hydrochlorothiazide

Orange BookUNIISPLATC C07AB

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

Identification

ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeC07AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7257811301
    100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01)
  • ndc11
    7257811305
    500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05)
  • ndc11
    7257811306
    30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)

Annotations

UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A215666
ABABAB
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": "72578-113_550e6ac5-3ece-461f-a9c5-2e4050a5eabb",
  "productndc": "72578-113",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215666",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;6.25MG",
        "product_no": "003",
        "approval_date": "Nov 4, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Bisoprolol Fumarate and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA215666",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bisoprolol fumarate and hydrochlorothiazide",
  "start_marketing_date": "20230301",
  "active_numerator_strength": "2.5; 6.25"
}

Related drugs

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