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United States · US · US:45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65

Kit for the Preparation of Technetium Tc 99m Mebrofenin

Orange BookUNIISPL

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4556704551
    5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    4556704552
    30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
7PV0B6ED98
MEBROFENIN
RxCUI 1311500
Orange Book
A078242
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7PV0B6ED98",
    "rxcui": "1311500",
    "inchikey": "MHPZZZZLAQGTHT-UHFFFAOYSA-N",
    "display_name": "MEBROFENIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "54608807-4df6-49ba-b065-59a19ef224c4": {
      "match": "brand_token",
      "title": "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65",
  "productndc": "45567-0455",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "078242",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Jan 29, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEBROFENIN",
  "proprietary_name": "Kit for the Preparation of Technetium Tc 99m Mebrofenin",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA078242",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Kit for the Preparation of Technetium Tc 99m Mebrofenin",
  "start_marketing_date": "20080129",
  "active_numerator_strength": "45"
}

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