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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
- ndc1145567045515 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE
- ndc11455670455230 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"
}Access this data programmatically
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