Fluorescein

Product NDC: 14789-122
11-digit product format: 147890122
Labeler code: 14789
Product ID: 14789-122_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorescein
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Nexus Pharmaceuticals LLC
Application: ANDA215709
Marketing category: ANDA
Marketing start: 2023-10-24
Substance: FLUORESCEIN
Active strength: 500 mg/mL
Pharmacologic classes: Diagnostic Dye [EPC], Dyes [MoA]
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 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
A215709-001	FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25
A215709-002	FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS			2023-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215709-001	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 2 · 42 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	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS			2023-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2023-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2023-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RS	2023-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215709-001	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215709-002	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2023-09-25	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215709-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215709-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215709-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215709-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215709-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215709-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215709-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215709-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215709-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215709-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215709-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215709-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215709-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215709-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215709-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215709-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215709-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215709-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215709-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215709-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215709-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215709-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215709-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215709-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215709-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215709-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215709-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215709-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215709-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215709-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215709-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215709-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215709-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215709-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215709-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215709-002	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215709-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215709-001	CGT	2024-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215709-001	CGT	2024-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215709-001	CGT	2024-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215709-001	CGT	2024-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215709-001	CGT	2024-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215709-001	CGT	2024-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215709-001	CGT	2024-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215709-001	CGT	2024-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215709-001	CGT	2024-04-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215709-001	CGT	2024-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215709-001	CGT	2024-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215709-001	CGT	2024-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215709-001	CGT	2024-04-21	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluorescein
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUORESCEIN	500 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TPY09G7XIR	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
0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14789-122-05	Fluorescein	10 in 1 CARTON	INJECTION	10		5
14789-122-07	Fluorescein	5 mL in 1 VIAL	INJECTION	5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
14789-122-05	ML - Milliliter	14789-122	e5c03851-104d-4f31-86ef-8d03beff3c22	1	2023-10-16
14789-122-07	ML - Milliliter	14789-122	75a14a07-9869-471e-b669-67c197eb7319	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14789-122	FLUORESCEIN INJECTION [NEXUS PHARMACEUTICALS LLC]	5	Current NDC, 2 package rows	20231026_0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c.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
Fluorescein	FLUORESCEIN	Nexus Pharmaceuticals LLC	0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215709 application number: ANDA215709 ndc (product): 14789-122

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TPY09G7XIR	FLUORESCEIN	2321-07-5	FLUORESCEIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
14789-122-05	14789012205	10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)	10 vial	2023-10-24	No	No	Current
14789-122-07	14789012207	5 mL in 1 VIAL	5 ml				Historical