Home NDC 54288-179 Fluorescein
Product NDC 54288-179
11-digit product format 542880179
Labeler code 54288
Product ID 54288-179_5b9c9100-13f7-4eab-a770-339aa885a949
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorescein
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BPI Labs LLC
Application ANDA220046
Marketing category ANDA
Marketing start 2026-05-20
Substance FLUORESCEIN SODIUM
Active strength 500 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220046-001 FLUORESCEIN SODIUM FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220046-001 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.
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 A220046-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-04-30 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220046-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-04-30 a50c72e98297…
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 A220046-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220046-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Fluorescein
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUORESCEIN SODIUM 500 mg/5mL
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 54288-179-01 Fluorescein 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 1 54288-179-10 Fluorescein 10 in 1 CARTON INJECTION, SOLUTION 10 1
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 54288-179-01 54288017901 5 mL in 1 VIAL, GLASS 5 ml Historical 54288-179-10 54288017910 10 VIAL, GLASS in 1 CARTON (54288-179-10) / 5 mL in 1 VIAL, GLASS (54288-179-01) 2026-05-20 No No Current