Home NDC 0407-8787 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 0407-8787 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0407-8787 0407-8787-01 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215168-001 FLYRCADO FLURPIRIDAZ F-18 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 N215168-001 12527884 2042-05-13 U-4406 Drug product 2026-02-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215168-001 NCE 2029-09-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215168-001 FLYRCADO 5-55mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2024-09-27 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 63 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215168-001 12527884 2042-05-13 U-4406 Drug product 2026-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215168-001 12527884 2042-05-13 U-4406 Drug product 2026-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 8226929 2028-06-21 U-4011 2024-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 9603951 2031-05-02 U-4011 2024-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 8936777 2031-06-30 U-4011 2024-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 9687571 2032-11-01 U-4011 Drug product 2024-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215168-001 9161997 2026-02-04 U-4011 Drug substance, Drug product 2024-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215168-001 7344702 2026-05-26 Drug substance 2024-10-22 03ed91905a0d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N215168-001 NCE 2029-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215168-001 NCE 2029-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215168-001 NCE 2029-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215168-001 NCE 2029-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215168-001 NCE 2029-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215168-001 NCE 2029-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215168-001 NCE 2029-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215168-001 NCE 2029-09-27 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215168-001 NCE 2029-09-27 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215168-001 NCE 2029-09-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Flyrcado
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLURPIRIDAZ F-18 55 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TY3V24C029 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0407-8787-01 Flyrcado 30 mL in 1 VIAL, GLASS INJECTION 30 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-8787 FLYRCADO (FLURPIRIDAZ F-18) INJECTION [GE HEALTHCARE] 7 Current NDC, 1 package rows 20250221_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0407-8787-01 00407878701 30 mL in 1 VIAL, GLASS (0407-8787-01) 30 ml 2025-02-19 No No Current