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United States · US · US:71258-022_db2acb00-3e3b-4ecc-b532-08e456075404
PYLARIFY
Orange BookUNIISPLATC V09IX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProgenics Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeV09IX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11712580220150 mL in 1 VIAL, MULTI-DOSE (71258-022-01)
Annotations
UNII (FDA Substance ID)
3934EF02T7
PIFLUFOLASTAT F-18
RxCUI 2556616
Orange Book
N214793
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3934EF02T7",
"rxcui": "2556616",
"inchikey": "OLWVRJUNLXQDSP-MVBOSPHXSA-N",
"display_name": "PIFLUFOLASTAT F-18",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"a00e5cbc-4fd5-4280-82ec-cd3498df4553": {
"match": "brand_token",
"title": "PYLARIFY (PIFLUFOLASTAT F-18) INJECTION [PROGENICS PHARMACEUTICALS, INC.]",
"spl_version": "11",
"published_date": "2026-03-09"
}
},
"productid": "71258-022_db2acb00-3e3b-4ecc-b532-08e456075404",
"productndc": "71258-022",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214793",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50ML (1-80mCi/ML)",
"product_no": "001",
"approval_date": "May 26, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIFLUFOLASTAT F-18",
"proprietary_name": "PYLARIFY",
"active_ingred_unit": "mCi/mL",
"application_number": "NDA214793",
"marketing_category": "NDA",
"nonproprietary_name": "PIFLUFOLASTAT F-18",
"start_marketing_date": "20210526",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code V09IX16.
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