Flyrcado

Product NDC: 0407-8787
11-digit product format: 004078787
Labeler code: 0407
Product ID: 0407-8787_847843e3-b545-4e1b-b243-fc896841bb72
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 43.

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`84e616aacf4f…`
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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215168-001	12527884	2042-05-13	U-4406	Drug product	2026-02-11	`84e616aacf4f…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215168-001	NCE	2029-09-27	`84e616aacf4f…`
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…`

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: Flyrcado
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLURPIRIDAZ F-18	55 mCi/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
153e5130-0f3b-4191-a2be-e091e6910a70	Product name	1	20250423
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0407-8787-01	EA - Each	0407-8787	901073cd-0bc6-4ff6-ab31-0424d71b6acd	1	2024-12-10

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TY3V24C029	FLURPIRIDAZ F-18	863887-89-2	FLURPIRIDAZ F-18

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flyrcado	GE Healthcare Inc. \| Pharmalogic Cincinnati, OH \| Cardinal Health 414, LLC (Ft. Lauderdale, FL) \| Cardinal Health 418, Inc. (Aurora, CO) \| GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) \| Cardinal Health 414, LLC (Beltsville, MD) \| Cardinal Health, Inc. (Houston, TX) \| Cardinal Health 414, LLC (Tampa, FL) \| Cardinal Health 414, LLC (Charlotte, NC) \| Cardinal Health 414, LLC (Colton, CA) \| Cardinal Health 414, LLC (New Orleans, LA) \| Cardinal Health 414, LLC (Phoenix, AZ) \| Cardinal Health 414, LLC (Dallas, TX) \| Cardinal Health, Inc. (Glendale Heights, IL) \| Cardinal Health 414, LLC (E. Hartford, CT) \| Cardinal Health 414, LLC (Seattle, WA) \| Pharmalogic New York City, LLC \| Pharmalogic Los Angeles, LLC \| PharmaLogic Salt Lake City, LLC \| Hot Shots Nm, LLC \| Pharmalogic Austin, LLC \| Precision Nuclear, LLC (Johnson City, TN) \| Essential Isotopes, LLC. (Colombia, MO) \| Pharmalogic Colorado, LLC \| SOFIE Co. dba SOFIE (Sanford, FL) \| SOFIE Co. dba SOFIE (Romeoville, IL) \| SOFIE Co. dba SOFIE (Sterling, VA) \| N-Molecular, Inc. dba SOFIE \| N-Molecular, Inc. dba SOFIE (Oakwood Village, OH) \| SOFIE Co. dba SOFIE (Totowa, NJ) \| SOFIE Co. dba SOFIE (Kansas City, MO) \| Wisconsin Medical Radiopharmacy, LLC \| SOFIE Co. dba SOFIE (Gilroy, CA) \| Pharmalogic Georgia, LLC \| SOFIE Co. dba SOFIE (Morgantown, WV) \| SOFIE Co. dba SOFIE (Dallas TX) \| SOFIE Co. dba SOFIE (Houston, TX) \| Cardinal Health 414, LLC (Sacramento, CA) \| Pharmalogic South Carolina, LLC	2026-10-02	HUMAN PRESCRIPTION DRUG LABEL	30