Bisoprolol Fumarate and Hydrochlorothiazide

Orange BookUNIISPLATC C07AB

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC07AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5965167801
100 TABLET, FILM COATED in 1 BOTTLE (59651-678-01)
ndc11
5965167805
500 TABLET, FILM COATED in 1 BOTTLE (59651-678-05)
ndc11
5965167830
30 TABLET, FILM COATED in 1 BOTTLE (59651-678-30)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A217922

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": "59651-678_2db1a899-f115-4da5-89fe-6e5b41086f6c",
  "productndc": "59651-678",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217922",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Jan 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "002",
        "approval_date": "Jan 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;6.25MG",
        "product_no": "003",
        "approval_date": "Jan 21, 2026"
      }
    ],
    "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": "ANDA217922",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol Fumarate and Hydrochlorothiazide",
  "start_marketing_date": "20260121",
  "active_numerator_strength": "2.5; 6.25"
}

Related drugs

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