Home NDC 59390-205 Fluorescein Sodium and Proparacaine Hydrochloride
Product NDC 59390-205
11-digit product format 593900205
Labeler code 59390
Product ID 59390-205_bb57078b-c74f-41e3-bcaf-51225b4fb526
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorescein Sodium and Proparacaine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Altaire Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2000-06-14
Substance FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE
Active strength 2.5; 5 mg/mL; mg/mL
Pharmacologic classes Diagnostic Dye [EPC], Dyes [MoA], Local Anesthesia [PE], Local Anesthetic [EPC]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 59390-205 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59390-205 59390-205-05 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Sodium and Proparacaine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUORESCEIN SODIUM 2.5 mg/mL PROPARACAINE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 93X55PE38X Internal UNII lookup U96OL57GOY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1247445 Internal RxNorm 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 59390-205-05 Fluorescein Sodium and Proparacaine Hydrochloride 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 10 59390-205-05 Fluorescein Sodium and Proparacaine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59390-205 FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] 10 Current NDC, Legacy NDC, 2 package rows 20221102_dae037ad-dcb8-42e6-8996-e575922d7631.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59390-205-05 59390020505 1 BOTTLE, DROPPER in 1 CARTON (59390-205-05) / 5 mL in 1 BOTTLE, DROPPER 2000-06-14 0000-00-00 No No Current