FUL-GLO

Product NDC: 17478-404
11-digit product format: 174780404
Labeler code: 17478
Product ID: 17478-404_2dc13f8d-ae12-44e5-90f3-f8fbbff0f4e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorescein Sodium
Dosage form: STRIP
Route: OPHTHALMIC
Labeler: Akorn
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2004-06-01
Marketing end: 0000-00-00
Substance: FLUORESCEIN SODIUM
Active strength: 1 mg/1
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	17478-404		I	Inactivated by FDA		2026-08-17
excluded package	package	17478-404	17478-404-01	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 · 32 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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`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	17478-404-01	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	17478-404-01	`110d247fa046…`	`a55b01930146…`

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
17478-404-01	2024-01-30	C162847	48780-1	97449f38-d0fa-f6ea-e053-dbdaa90aa703	Fluorescein Sodium Ophthalmic Strips, USP
17478-404-01	2020-01-14	C162847	48780-1	97449f38-d0fa-f6ea-e053-dbdaa90aa703	Fluorescein Sodium Ophthalmic Strips, USP
17478-404-01	2019-11-13	C162847	48780-1	97449f38-d0fa-f6ea-e053-dbdaa90aa703	Fluorescein Sodium Ophthalmic Strips, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-404-01	FUL-GLO	1 in 1 APPLICATOR	STRIP	1		8
17478-404-01	FUL-GLO	100 in 1 CARTON	STRIP	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-404-01	EA - Each	17478-404	0be063cf-d433-40aa-bc66-5aeed84cc520	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
D&C YELLOW NO. 8	ACTIVE INGREDIENT	93X55PE38X	FUL-GLO (FLUORESCEIN SODIUM) STRIP [AKORN, INC.]	1
Fluorescein	ACTIVE MOIETY	TPY09G7XIR	FUL-GLO (FLUORESCEIN SODIUM) STRIP [AKORN, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-404	FUL-GLO (FLUORESCEIN SODIUM) STRIP [AKORN]	8	Legacy NDC, 2 package rows	20220914_b297d7a1-2fc4-4e4f-9821-2a1985b61ae0.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-404-01	17478040401	100 APPLICATOR in 1 CARTON (17478-404-01) > 1 STRIP in 1 APPLICATOR	100 applicator	2004-06-01	0000-00-00	No	No	Current