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United States · US · US:17156-067_4fda8ebc-b46e-4d12-9c45-8cbb3a2516bb
Vizamyl
Orange BookUNIISPLATC V09AX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
CountryUS (United States)
ATC codeV09AX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1117156067301 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
L49M066S0O
FLUTEMETAMOL F-18
RxCUI 1486025
Orange Book
N203137
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L49M066S0O",
"rxcui": "1486025",
"inchikey": "VVECGOCJFKTUAX-HUYCHCPVSA-N",
"display_name": "FLUTEMETAMOL F-18",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b3558f16-8f9a-4e55-8d9c-836427ebaa57": {
"match": "brand_token",
"title": "VIZAMYL (FLUTEMETAMOL F-18) SOLUTION [GE HEALTHCARE INC. (MEDI-PHYSICS, INC. DBA GE HEALTHCARE)]",
"spl_version": "31",
"published_date": "2026-04-15"
}
},
"productid": "17156-067_4fda8ebc-b46e-4d12-9c45-8cbb3a2516bb",
"productndc": "17156-067",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "203137",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "40.5mCi/10ML (4.05mCi/ML)",
"product_no": "001",
"approval_date": "Oct 25, 2013"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "121.5mCi/30ML (4.05mCi/ML)",
"product_no": "002",
"approval_date": "Oct 25, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUTEMETAMOL F-18",
"proprietary_name": "Vizamyl",
"active_ingred_unit": "mCi/mL",
"application_number": "NDA203137",
"marketing_category": "NDA",
"nonproprietary_name": "Flutemetamol F-18",
"start_marketing_date": "20140101",
"active_numerator_strength": "4.05"
}Related drugs
Other records sharing ATC code V09AX04.
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