FDA.reportPublic FDA data

PYLARIFY TRUVU

Product NDC
85347-001
Requested package NDC
85347-001-01
11-digit product format
853470001
Labeler code
85347
Product ID
85347-001_558f7e93-a905-767a-e063-6294a90a1527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIFLUFOLASTAT F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Aphelion LLC
Application
NDA220089
Marketing category
NDA
Marketing start
2026-07-01
Substance
PIFLUFOLASTAT F-18
Active strength
120 mCi/mL
Pharmacologic classes
Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220089-001PYLARIFY TRUVUPIFLUFOLASTAT F-181mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220089-00184871292027-11-07Drug substance, Drug product2026-04-03
N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03
N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03
N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03
N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03
N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220089-001NCE2026-05-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-0684e616aacf4f…
2026-08-18 06:07:402026-07N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001PYLARIFY TRUVU1mCi/mL-120mCi/mLSOLUTION / INTRAVENOUSRLD, RS2026-03-06a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N220089-00184871292027-11-07Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-0384e616aacf4f…
2026-08-18 06:07:402026-07N220089-00184871292027-11-07Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00184871292027-11-07Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001120705132029-07-31U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00198617132029-07-31U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-00187783052030-09-21U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001109471972037-06-09U-3317Drug substance, Drug product2026-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001118514072037-06-09U-3317Drug substance, Drug product2026-04-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N220089-001NCE2026-05-2684e616aacf4f…
2026-08-18 06:07:402026-07N220089-001NCE2026-05-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220089-001NCE2026-05-26a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
PYLARIFY TRUVU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIFLUFOLASTAT F-18120 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3934EF02T7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
121c1cb8-6f60-4644-a775-b81c6f21d812Available on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85347-001-01EA - Each85347-001223f304a-e123-400d-8777-24ea7f27950612026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PYLARIFY TRUVUPIFLUFOLASTAT F-18Aphelion LLC121c1cb8-6f60-4644-a775-b81c6f21d8122026-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 220089
application number: NDA220089
ndc (package): 85347-001-01
ndc (product): 85347-001
ndc11 (package): 85347000101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85347-001-018534700010150 mL in 1 VIAL, GLASS (85347-001-01) 50 ml2026-07-01NoNoCurrent