Home NDC 81298-8660 AK-FLUOR
Product NDC 81298-8660
11-digit product format 812988660
Labeler code 81298
Product ID 81298-8660_ceefeb58-5c89-4157-a0bc-8a1409dc3873
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorescein
Dosage form INJECTION
Route INTRAVENOUS
Labeler Long Grove Pharmaceuticals, LLC
Application NDA022186
Marketing category NDA
Marketing start 2024-09-28
Substance FLUORESCEIN SODIUM
Active strength 100 mg/mL
Pharmacologic classes Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base AK-FLUOR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUORESCEIN SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 93X55PE38X Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81298-8660-1 AK-FLUOR 5 mL in 1 VIAL, GLASS INJECTION 5 4 81298-8660-3 AK-FLUOR 12 in 1 CARTON INJECTION 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81298-8660 AK-FLUOR (FLUORESCEIN) INJECTION [LONG GROVE PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20250316_73511e79-c050-4dc0-aa2f-a79ed320b5b0.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81298-8660-1 81298866001 5 mL in 1 VIAL, GLASS 5 ml Historical 81298-8660-3 81298866003 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) 2024-09-28 No No Current