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United States · US · US:67184-0572_b4283ace-4312-4cab-97c2-0722339d75b9

Mirabgeorn

Orange BookUNIIATC G04BD12

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeG04BD12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6718405721
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-1)
  • ndc11
    6718405722
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0572-2)

Annotations

UNII (FDA Substance ID)
MVR3JL3B2V
MIRABEGRON
RxCUI 1300786
Orange Book
A217989
ABAB
Raw payload (JSON)
{
  "unii": {
    "unii": "MVR3JL3B2V",
    "rxcui": "1300786",
    "inchikey": "PBAPPPCECJKMCM-IBGZPJMESA-N",
    "display_name": "MIRABEGRON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "67184-0572_b4283ace-4312-4cab-97c2-0722339d75b9",
  "productndc": "67184-0572",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217989",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jun 30, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jun 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRABEGRON",
  "proprietary_name": "Mirabgeorn",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217989",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mirabegron",
  "start_marketing_date": "20250630",
  "active_numerator_strength": "50"
}

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