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United States · US · US:50090-6478_e4a9e83b-5cbd-4c4e-9fd5-2b02607e6e75

bisoprolol fumarate and hydrochlorothiazide

Orange BookUNIISPLATC C07AB

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC07AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009064780
    30 TABLET, FILM COATED in 1 BOTTLE (50090-6478-0)

Annotations

UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
N020186
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": "50090-6478_e4a9e83b-5cbd-4c4e-9fd5-2b02607e6e75",
  "productndc": "50090-6478",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020186",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Mar 26, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;6.25MG",
        "product_no": "002",
        "approval_date": "Mar 26, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;6.25MG",
        "product_no": "003",
        "approval_date": "Mar 26, 1993"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA020186",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "bisoprolol fumarate and hydrochlorothiazide",
  "start_marketing_date": "20190807",
  "active_numerator_strength": "2.5; 6.25"
}

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