bisoprolol fumarate and hydrochlorothiazide

Orange BookUNIISPLATC C07AB

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeC07AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
2930018901
100 TABLET in 1 BOTTLE, PLASTIC (29300-189-01)
ndc11
2930018905
500 TABLET in 1 BOTTLE, PLASTIC (29300-189-05)
ndc11
2930018910
1000 TABLET in 1 BOTTLE, PLASTIC (29300-189-10)
ndc11
2930018913
30 TABLET in 1 BOTTLE, PLASTIC (29300-189-13)

Annotations

UNII (FDA Substance ID)

UR59KN573L

BISOPROLOL FUMARATE

RxCUI 142146

Orange Book

A079106

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": "29300-189_057844aa-5d7e-4e83-b71f-9072d2a2b93d",
  "productndc": "29300-189",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "079106",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "002",
        "approval_date": "Jul 28, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;6.25MG",
        "product_no": "003",
        "approval_date": "Jul 28, 2010"
      }
    ],
    "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": "ANDA079106",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bisoprolol fumarate and hydrochlorothiazide",
  "start_marketing_date": "20101012",
  "active_numerator_strength": "10; 6.25"
}

Related drugs

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