Fludeoxyglucose F-18

Product NDC: 16129-001
11-digit product format: 161290001
Labeler code: 16129
Product ID: 16129-001_f4d59ef8-294d-496d-ab37-6a2b1f09774b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fludeoxyglucose F-18
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Pharmalogic South Carolina, LLC
Application: ANDA204264
Marketing category: ANDA
Marketing start: 2006-03-29
Marketing end: 2026-06-05
Substance: FLUDEOXYGLUCOSE F-18
Active strength: 300 mCi/mL
Pharmacologic classes: Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16129-001		D	Discontinued by firm	2026-08-17
excluded package	package	16129-001	16129-001-10	D	Discontinued by firm	2026-08-17
excluded package	package	16129-001	16129-001-30	D	Discontinued by firm	2026-08-17

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
A204264-001	FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-300mCi/ML	INJECTABLE / INTRAVENOUS			2014-12-18

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS		2014-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204264-001	FLUDEOXYGLUCOSE F18	20-300mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-12-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204264-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204264-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204264-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204264-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204264-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204264-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204264-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204264-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204264-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204264-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204264-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204264-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204264-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204264-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204264-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204264-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204264-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204264-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204264-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204264-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204264-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204264-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204264-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204264-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204264-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204264-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204264-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204264-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204264-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204264-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204264-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204264-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204264-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204264-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204264-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204264-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204264-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204264-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204264-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204264-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a8297d3a-f6a8-4d2b-8fce-c063a35f1186	Product name	2	20251210
858c9b08-fb6b-48b9-8516-ea929654e228	Product name	2	20160606
6d7dfd10-cccc-49a1-a5c7-1842491e3644	Product name	2	20151125
b370ef4e-503e-4658-af90-e40f1dd3ff26	Product name	9	20151106
a838cd4c-e408-4023-a03d-912949043ddc	Product name	2	20151029
bce34a5c-800a-42cd-a264-d5a0d09eed8a	Product name	1	20150902
99a01b5c-59f4-409d-9148-0a2993e6f287	Product name	1	20150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16129-001-10	Fludeoxyglucose F-18	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10		15
16129-001-30	Fludeoxyglucose F-18	30 mL in 1 VIAL, MULTI-DOSE	INJECTION	30		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUDEOXYGLUCOSE F-18	ACTIVE INGREDIENT	0Z5B2CJX4D	FLUDEOXYGLUCOSE F-18 INJECTION [SHERTECH LABORATORIES, LLC]	6
FLUDEOXYGLUCOSE F-18	ACTIVE MOIETY	0Z5B2CJX4D	FLUDEOXYGLUCOSE F-18 INJECTION [SHERTECH LABORATORIES, LLC]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FLUDEOXYGLUCOSE F-18 INJECTION [SHERTECH LABORATORIES, LLC]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUDEOXYGLUCOSE F-18 INJECTION [SHERTECH LABORATORIES, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16129-001	FLUDEOXYGLUCOSE F-18 INJECTION [PHARMALOGIC SOUTH CAROLINA, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20240405_3535020f-26c3-40b8-bdb5-1aaa1857ba57.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0Z5B2CJX4D	FLUDEOXYGLUCOSE F-18	63503-12-8	FLUDEOXYGLUCOSE 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
16129-001-10	16129000110	10 mL in 1 VIAL, MULTI-DOSE (16129-001-10)	10 ml	2006-03-29	0000-00-00	No	No	Current
16129-001-30	16129000130	30 mL in 1 VIAL, MULTI-DOSE (16129-001-30)	30 ml	2006-03-29	0000-00-00	No	No	Current