🇺🇸
United States · US · US:54288-179_5b9c9100-13f7-4eab-a770-339aa885a949
Fluorescein
Orange BookUNIISPLATC S01JA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBPI Labs LLC
CountryUS (United States)
ATC codeS01JA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11542881791010 VIAL, GLASS in 1 CARTON (54288-179-10) / 5 mL in 1 VIAL, GLASS (54288-179-01)
Annotations
UNII (FDA Substance ID)
93X55PE38X
FLUORESCEIN SODIUM
RxCUI 57789
Orange Book
A220046
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": "INTRAVENOUS",
"spl_meta": {
"770582e3-c99b-4a02-868c-29309013717e": {
"match": "brand_token",
"title": "FLUORESCEIN INJECTION, SOLUTION [BPI LABS LLC]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "54288-179_5b9c9100-13f7-4eab-a770-339aa885a949",
"productndc": "54288-179",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "220046",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 30, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUORESCEIN SODIUM",
"proprietary_name": "Fluorescein",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA220046",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluorescein",
"start_marketing_date": "20260520",
"active_numerator_strength": "500"
}Related drugs
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- GBAnatera 500mg/5ml solution for injection vialsAlcon Eye Care UK Ltd
- 🇺🇸C20H10Na2O5 Fluorescein Sodium Ophthalmic StripsVistamerica USA
- DKCombiflureSanten Oy
- NOCombiflureSanten Oy
- BECombiflure 1.25 mg/ml - 3 mg/mlSanten
- 🇺🇸Dry Eye TestNomax Inc.
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