Axumin

Product NDC: 69932-001
11-digit product format: 699320001
Labeler code: 69932
Product ID: 69932-001_2f9c7d6f-7f0f-f9dd-e063-6294a90abf59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluciclovine F-18
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Blue Earth Diagnostics
Application: NDA208054
Marketing category: NDA
Marketing start: 2016-05-27
Substance: FLUCICLOVINE F-18
Active strength: 221 mCi/mL
Pharmacologic classes: Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208054-001	AXUMIN	FLUCICLOVINE F-18	9-221mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208054-001	10010632	2026-11-28		Drug product	2018-07-27
N208054-001	10953112	2026-11-28	U-1879		2021-04-20
N208054-001	9387266	2026-11-28	U-1879		2016-07-28
N208054-001	10124079	2035-12-30	U-2450		2018-12-12
N208054-001	10716868	2035-12-30	U-2450		2020-07-22
N208054-001	10933147	2035-12-30	U-2450		2021-03-09
N208054-001	10967077	2035-12-30	U-2450		2021-04-20
N208054-001	11980674	2042-04-23	U-2450		2024-06-10

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.

Product history page 1 of 2 · 43 observed 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	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 296 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	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208054-001	NCE	2021-05-27	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208054-001	NCE	2021-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208054-001	NCE	2021-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208054-001	NCE	2021-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208054-001	NCE	2021-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208054-001	NCE	2021-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208054-001	NCE	2021-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208054-001	NCE	2021-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208054-001	NCE	2021-05-27	`ea99ee380514…`

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: Axumin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCICLOVINE F-18	221 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38R1Q0L1ZE	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
389a502e-a7d5-43dd-b6bf-f022ff23f3b9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99c34776-fee5-4e61-ac29-ba8502969eda	Product name	1	20160712

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69932-001-30	Axumin	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30		16
69932-001-50	Axumin	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69932-001-50	EA - Each	69932-001	3f56e11d-2ae6-464b-874e-b60480b954fd	1	2026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69932-001	AXUMIN (FLUCICLOVINE F-18) INJECTION, SOLUTION [BLUE EARTH DIAGNOSTICS]	16	Current NDC, Legacy NDC, 2 package rows	20250308_389a502e-a7d5-43dd-b6bf-f022ff23f3b9.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Axumin	FLUCICLOVINE F-18	Blue Earth Diagnostics	389a502e-a7d5-43dd-b6bf-f022ff23f3b9	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208054 application number: NDA208054 ndc (product): 69932-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
38R1Q0L1ZE	FLUCICLOVINE F-18	222727-39-1	FLUCICLOVINE F-18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69932-001-30	69932000130	30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)	30 ml	2016-05-27	0000-00-00	No	No	Current
69932-001-50	69932000150	50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)	50 ml	2016-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Axumin	Blue Earth Diagnostics \| PETNET Solutions, Inc. (Philadelphia) \| The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute \| PETNET Solutions, Inc.(Seattle) \| PETNET Solutions, Inc. (Denver) \| PETNET Solutions, Inc. (Jacksonville) \| PETNET Solutions, Inc. (Portland) \| PETNET Solutions, Inc. (San Antonio) \| PETNET Solutions, Inc. (Columbia) \| PETNET Solutions, Inc. (New Orleans) \| GE Healthcare AS \| PETNET Solutions, Inc. (Phoenix) \| P.E.T.NET Houston, LLC \| PETNET Solutions, Inc. (Tampa) \| PETNET Solutions, Inc. (Hackensack) \| PETNET Solutions, Inc. (Tulsa) \| PETNET Solutions, Inc. (Dallas) \| PETNET Solutions, Inc. (Nashville) \| PETNET Solutions, Inc. (Atlanta) \| PETNET Solutions, Inc. (Cincinnati) \| PETNET Solutions, Inc. (Louisville) \| PETNET Solutions, Inc. (Winston-Salem) \| PETNET Solutions, Inc. (Cleveland) \| PETNET Solutions, Inc. (Albany) \| PETNET Solutions, Inc. (Sacramento) \| PETNET Solutions, Inc. (Little Rock) \| PETNET Solutions, Inc. (Boston) \| PETNET Solutions, Inc. (Loma Linda) \| PETNET Solutions, Inc. (San Francisco) \| PETNET Solutions, Inc. (Kansas City) \| PETNET Solutions, Inc. (Spokane) \| PETNET Solutions, Inc. (Detroit) \| PETNET Solutions, Inc. (Albuquerque) \| PETNET Solutions, Inc. (Minneapolis) \| PETNET Solutions, Inc. (Charlottesville) \| PETNET Solutions Inc (South Florida) \| PETNET Solutions Inc (Las Vegas) \| PETNET Solutions Inc (Chicago 2) \| PETNET Solutions Inc. (Culver City)	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	16