FDA.reportPublic FDA data

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
Marketing end
0000-00-00
Substance
FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA], Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59390-205DDiscontinued by firm2026-10-15
excluded packagepackage59390-20559390-205-05DDiscontinued by firm2026-10-15

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct59390-205EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59390-20559390-205-05EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-205-05Fluorescein Sodium and Proparacaine Hydrochloride5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS510
59390-205-05Fluorescein Sodium and Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-205-05ML - Milliliter59390-2051fc6d9d0-e1df-449a-a381-ea831f74f1a112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUORESCEIN SODIUMACTIVE INGREDIENT93X55PE38XFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
PROPARACAINE HYDROCHLORIDEACTIVE INGREDIENTU96OL57GOYFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
FLUORESCEINACTIVE MOIETYTPY09G7XIRFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
PROPARACAINEACTIVE MOIETYB4OB0JHI1XFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RFLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-205FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]10Legacy NDC, 2 package rows20221102_dae037ad-dcb8-42e6-8996-e575922d7631.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247445fluorescein sodium 0.25 % / proparacaine HCl 0.5 % Ophthalmic SolutionPSNdae037ad-dcb8-42e6-8996-e575922d763110
1247445fluorescein sodium 2.5 MG/ML / proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCDdae037ad-dcb8-42e6-8996-e575922d763110
1247445fluorescein sodium 0.25 % / proparacaine hydrochloride 0.5 % Ophthalmic DropsSYdae037ad-dcb8-42e6-8996-e575922d763110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59390-205-05593900205051 BOTTLE, DROPPER in 1 CARTON (59390-205-05) > 5 mL in 1 BOTTLE, DROPPER2000-06-140000-00-00NoNoCurrent