🇺🇸
United States · US · US:0065-0092_85861756-9727-4a43-8a4e-48564e341c48
FLUORESCITE
Orange BookUNIISPLATC S01JA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon, Inc.
CountryUS (United States)
ATC codeS01JA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006500926512 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
93X55PE38X
FLUORESCEIN SODIUM
RxCUI 57789
Orange Book
N021980
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "93X55PE38X",
"rxcui": "57789",
"inchikey": "NJDNXYGOVLYJHP-UHFFFAOYSA-L",
"display_name": "FLUORESCEIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9": {
"match": "brand_token",
"title": "FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.]",
"spl_version": "18",
"published_date": "2023-12-15"
}
},
"productid": "0065-0092_85861756-9727-4a43-8a4e-48564e341c48",
"productndc": "0065-0092",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021980",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
"product_no": "001",
"approval_date": "Mar 28, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUORESCEIN SODIUM",
"proprietary_name": "FLUORESCITE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021980",
"marketing_category": "NDA",
"nonproprietary_name": "fluorescein sodium",
"start_marketing_date": "19720915",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code S01JA51.
- 🇺🇸AK-FLUORLong Grove Pharmaceuticals, LLC
- GBAK-Fluor 10% solution for injection 5ml ampoulesImported (United States)
- GBAnatera 500mg/5ml solution for injection vialsAlcon Eye Care UK Ltd
- 🇺🇸C20H10Na2O5 Fluorescein Sodium Ophthalmic StripsVistamerica USA
- NOCombiflureSanten Oy
- DKCombiflureSanten Oy
- BECombiflure 1.25 mg/ml - 3 mg/mlSanten
- 🇺🇸Dry Eye TestNomax Inc.
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