AK-FLUOR

Product NDC: 17478-250
11-digit product format: 174780250
Labeler code: 17478
Product ID: 17478-250_52511566-69ed-499f-aced-28825ea3c81a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluorescein sodium
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Application: NDA022186
Marketing category: NDA
Marketing start: 2008-10-01
Marketing end: 0000-00-00
Substance: FLUORESCEIN SODIUM
Active strength: 250 mg/mL
Pharmacologic classes: Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17478-250		I	Inactivated by FDA		2026-08-17
excluded package	package	17478-250	17478-250-20	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-250-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-250-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-250-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-250-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-250-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-250-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-250-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-250-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-250-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-250-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-250-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-250-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-250-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-250-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-250-20	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022186-001	AK-FLUOR 10%	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08
N022186-002	AK-FLUOR 25%	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022186-001	AP

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 3 · 84 observed 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	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022186-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022186-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022186-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022186-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022186-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022186-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022186-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022186-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022186-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022186-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022186-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022186-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022186-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022186-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022186-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022186-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022186-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022186-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022186-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022186-001	AP	1	`6a51e52b5d6a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f43a274-9585-47cb-b427-0eb3e578384d	Product name	1	20250623
4a998fa9-995e-4ea5-97ef-93a559305758	Product name	1	20200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2	Product name	1	20180215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-250-20	2024-01-30	C162847	48780-1	1030e365-1095-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AK-FLUOR ® 10% and AK-FLUOR ® 25% safely and effectively. See full prescribing information for the products in AK-FLUOR ® 10% and AK-FLUOR ® 25%. AK-FLUOR ® (fluorescein injection, USP) 10% and AK-FLUOR ® (fluorescein injection, USP) 25% Intravenous injection Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-250-20	AK-FLUOR	12 in 1 PACKAGE	INJECTION	12		12
17478-250-20	AK-FLUOR	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-250-20	ML - Milliliter	17478-250	05009756-78eb-42b8-b45a-681640fefe96	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
fluorescein sodium	ACTIVE INGREDIENT	93X55PE38X	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	6
fluorescein	ACTIVE MOIETY	TPY09G7XIR	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	6
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	6
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	6
water	INACTIVE INGREDIENT	059QF0KO0R	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-250	AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]	12	Legacy NDC, 2 package rows	20220911_a1823be3-a739-48bc-a3ea-ceb7cc5105ce.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AK-FLUOR	FLUORESCEIN	Long Grove Pharmaceuticals, LLC	73511e79-c050-4dc0-aa2f-a79ed320b5b0	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022186 application number: NDA022186
FLUORESCEIN	FLUORESCEIN	HF Acquisition Co LLC, DBA HealthFirst	c1ffe119-7fba-940f-e053-2a95a90a7a17	2021-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022186 application number: NDA022186

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
93X55PE38X	FLUORESCEIN SODIUM	518-47-8	FLUORESCEIN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-250-20	17478025020	12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-250-20) > 2 mL in 1 VIAL, SINGLE-DOSE	2008-10-01	0000-00-00	No	No	Current