Home NDC 14789-122-05 Fluorescein
Product NDC 14789-122
Requested package NDC 14789-122-05
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 44 .
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 · 46 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 2026-10-15 13:18:30 2026-09 A215709-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A215709-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS 2023-09-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215709-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215709-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS 2023-09-25 84e616aacf4f…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…
Observed Orange Book normalized TE history# 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# 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 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.
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