Home NDC 0065-0092 FLUORESCITE
Product NDC 0065-0092
11-digit product format 000650092
Labeler code 0065
Product ID 0065-0092_85861756-9727-4a43-8a4e-48564e341c48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorescein sodium
Dosage form INJECTION, SOLUTION
Route OPHTHALMIC
Labeler Alcon, Inc.
Application NDA021980
Marketing category NDA
Marketing start 1972-09-15
Substance FLUORESCEIN SODIUM
Active strength 100 mg/mL
Pharmacologic classes Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021980-001 FLUORESCITE FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021980-001 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 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FLUORESCITE
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 0065-0092-05 FLUORESCITE 12 in 1 CARTON INJECTION, SOLUTION 12 18 0065-0092-05 FLUORESCITE 5 mL in 1 VIAL INJECTION, SOLUTION 5 18 0065-0092-65 FLUORESCITE 5 mL in 1 VIAL INJECTION, SOLUTION 5 18 0065-0092-65 FLUORESCITE 12 in 1 CARTON INJECTION, SOLUTION 12 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUORESCEIN SODIUM ACTIVE INGREDIENT 93X55PE38X FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 6 FLUORESCEIN ACTIVE MOIETY TPY09G7XIR FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0092 FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] 18 Current NDC, Legacy NDC, 4 package rows 20231215_ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0065-0092-05 00065009205 12 in 1 CARTON Historical 0065-0092-65 00065009265 12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL 12 vial 1972-09-15 0000-00-00 No No Current