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United States · US · US:11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131
Definity
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLantheus Medical Imaging, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1111994011011 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS
- ndc1111994011044 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS
- ndc11119940111616 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
CK0N3WH0SR
PERFLUTREN
RxCUI 283753
Orange Book
N021064
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CK0N3WH0SR",
"rxcui": "283753",
"inchikey": "QYSGYZVSCZSLHT-UHFFFAOYSA-N",
"display_name": "PERFLUTREN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"7b9de6ab-a3ac-40c9-8103-139dc7a464a2": {
"match": "brand_token",
"title": "DEFINITY RT (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.]",
"spl_version": "9",
"published_date": "2024-03-18"
}
},
"productid": "11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131",
"productndc": "11994-011",
"dosage_form": "INJECTION, SUSPENSION",
"orange_book": {
"appl_no": "021064",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "13.04MG/2ML (6.52MG/ML)",
"product_no": "001",
"approval_date": "Jul 31, 2001"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "13.04MG/2ML (6.52MG/ML)",
"product_no": "002",
"approval_date": "Nov 17, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PERFLUTREN",
"proprietary_name": "Definity",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021064",
"marketing_category": "NDA",
"nonproprietary_name": "perflutren",
"start_marketing_date": "20010731",
"active_numerator_strength": "6.52"
}Access this data programmatically
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