Bisoprolol Fumarate and Hydrochlorothiazide

Orange BookUNIISPLATC C07AB

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC07AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1013574001
100 TABLET in 1 BOTTLE (10135-740-01)
ndc11
1013574005
500 TABLET in 1 BOTTLE (10135-740-05)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A215562

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": "10135-740_3f7bca13-71ae-c3ed-e063-6294a90ac734",
  "productndc": "10135-740",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215562",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;6.25MG",
        "product_no": "003",
        "approval_date": "Nov 4, 2021"
      }
    ],
    "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": "ANDA215562",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bisoprolol Fumarate and Hydrochlorothiazide",
  "start_marketing_date": "20220501",
  "active_numerator_strength": "2.5; 6.25"
}

Related drugs

Other records sharing ATC code C07AB.

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