Flyrcado

Product NDC
0407-8787
11-digit product format
004078787
Labeler code
0407
Product ID
0407-8787_40cd7563-6ae4-4f6b-8af9-45ad8b2427ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLURPIRIDAZ F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc.
Application
NDA215168
Marketing category
NDA
Marketing start
2025-02-19
Substance
FLURPIRIDAZ F-18
Active strength
55 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct0407-8787DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0407-87870407-8787-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N215168-001FLYRCADOFLURPIRIDAZ F-185-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-22
N215168-00173447022026-05-26Drug substance2024-10-22
N215168-00182269292028-06-21U-40112024-10-22
N215168-00196039512031-05-02U-40112024-10-22
N215168-00189367772031-06-30U-40112024-10-22
N215168-00196875712032-11-01U-4011Drug product2024-10-22
N215168-001125278842042-05-13U-4406Drug product2026-02-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215168-001NCE2029-09-27

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
2026-08-18 06:07:402026-07N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-272680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215168-001FLYRCADO5-55mCi/MLSOLUTION / INTRAVENOUSRLD, RS2024-09-27a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-00173447022026-05-26Drug substance2024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-00182269292028-06-21U-40112024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-00196039512031-05-02U-40112024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-00189367772031-06-30U-40112024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-00196875712032-11-01U-4011Drug product2024-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215168-001125278842042-05-13U-4406Drug product2026-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-00173447022026-05-26Drug substance2024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-00182269292028-06-21U-40112024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-00196039512031-05-02U-40112024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-00189367772031-06-30U-40112024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-00196875712032-11-01U-4011Drug product2024-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215168-001125278842042-05-13U-4406Drug product2026-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00173447022026-05-26Drug substance2024-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00182269292028-06-21U-40112024-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00196039512031-05-02U-40112024-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00189367772031-06-30U-40112024-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-00196875712032-11-01U-4011Drug product2024-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215168-00173447022026-05-26Drug substance2024-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215168-00182269292028-06-21U-40112024-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215168-00196039512031-05-02U-40112024-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215168-00189367772031-06-30U-40112024-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215168-00196875712032-11-01U-4011Drug product2024-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00173447022026-05-26Drug substance2024-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00182269292028-06-21U-40112024-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00196039512031-05-02U-40112024-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00189367772031-06-30U-40112024-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-00196875712032-11-01U-4011Drug product2024-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00173447022026-05-26Drug substance2024-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00182269292028-06-21U-40112024-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00196039512031-05-02U-40112024-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00189367772031-06-30U-40112024-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-00196875712032-11-01U-4011Drug product2024-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215168-00191619972026-02-04U-4011Drug substance, Drug product2024-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215168-00173447022026-05-26Drug substance2024-10-2203ed91905a0d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N215168-001NCE2029-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215168-001NCE2029-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215168-001NCE2029-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N215168-001NCE2029-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215168-001NCE2029-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215168-001NCE2029-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215168-001NCE2029-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215168-001NCE2029-09-272680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215168-001NCE2029-09-27d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215168-001NCE2029-09-27a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURPIRIDAZ F-1855 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TY3V24C029Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bb6caf8-ac98-46c7-a9f0-961e66032705Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
153e5130-0f3b-4191-a2be-e091e6910a70Product name120250423
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-8787-01Flyrcado30 mL in 1 VIAL, GLASSINJECTION3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-8787-01EA - Each0407-8787901073cd-0bc6-4ff6-ab31-0424d71b6acd12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-8787FLYRCADO (FLURPIRIDAZ F-18) INJECTION [GE HEALTHCARE]7Current NDC, 1 package rows20250221_3bb6caf8-ac98-46c7-a9f0-961e66032705.zip

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
FlyrcadoFLURPIRIDAZ F-18GE Healthcare Inc.3bb6caf8-ac98-46c7-a9f0-961e660327052026-07-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 215168
application number: NDA215168
ndc (product): 0407-8787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0407-8787-010040787870130 mL in 1 VIAL, GLASS (0407-8787-01) 30 ml2025-02-19NoNoCurrent