All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

fluorescein 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
fluorescent imaging agents, fluorescein derivatives	1207	518-47-8

Description:

Molecule	Description
Synonyms: fluorescein fluorescein acid resorcinolphthalein yellow fluorescein fluorescein sodium	A phthalic indicator dye that appears yellow-green in normal tear film and bright green in a more alkaline medium such as the aqueous humor. Molecular weight: 376.28 Formula: C20H10Na2O5 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 89.49 ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	23.17 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.14 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.11 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.60 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	500 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
March 9, 2020	FDA	BAUSCH

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaphylactic shock	94.59	56.31	24	452	23609	63464937
Haemangioma congenital	78.07	56.31	11	465	441	63488105

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaphylactic shock	165.11	63.67	41	573	15900	34940417

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaphylactic shock	234.25	56.69	60	963	35936	79707429
Anaphylactic reaction	81.60	56.69	33	990	83710	79659655
Chest discomfort	59.93	56.69	31	992	138013	79605352

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	S01JA01	SENSORY ORGANS OPHTHALMOLOGICALS DIAGNOSTIC AGENTS Colouring agents
ATC	S01JA51	SENSORY ORGANS OPHTHALMOLOGICALS DIAGNOSTIC AGENTS Colouring agents
FDA MoA	N0000175533	Dyes
FDA EPC	N0000175536	Diagnostic Dye
CHEBI has role	CHEBI:37338	contrast media
CHEBI has role	CHEBI:51121	fluorescent dyes
MeSH PA	D004396	Coloring Agents
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals
MeSH PA	D005456	Fluorescent Dyes
MeSH PA	D007202	Indicators and Reagents
MeSH PA	D049408	Luminescent Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Fluorescein staining of eye	indication	414273009
Administration of Corneal Anesthesia	off-label use
Local Anesthesia for Ophthalmologic Procedure	off-label use

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10293047	Nov. 15, 2037	OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10632197	Nov. 15, 2037	OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10842872	Nov. 15, 2037	PROCEDURES IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC.

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6.04		DRUG MATRIX
Protein arginine N-methyltransferase 1	Enzyme	Q99873	ANM1_HUMAN		IC50	4.12		CHEMBL
Solute carrier family 22 member 6	Transporter		S22A6_MOUSE		Ki	5.53		CHEMBL
Solute carrier family 22 member 20	Transporter		S22AK_MOUSE		Ki	4		CHEMBL

External reference:

ID	Source
4019760	VUID
N0000147851	NUI
D01261	KEGG_DRUG
4018582	VANDF
4019760	VANDF
C0060520	UMLSCUI
CHEBI:172923	CHEBI
FLU	PDB_CHEM_ID
CHEMBL4297067	ChEMBL_ID
CHEMBL177756	ChEMBL_ID
DB00693	DRUGBANK_ID
CHEMBL1628233	ChEMBL_ID
D019793	MESH_DESCRIPTOR_UI
16850	PUBCHEM_CID
TPY09G7XIR	UNII
25138	RXNORM
149	MMSL
20713	MMSL
4740	MMSL
80888	MMSL
82367	MMSL
NOCODE	MMSL
d05815	MMSL
002214	NDDF
004884	NDDF
010152	NDDF
25351006	SNOMEDCT_US
350086004	SNOMEDCT_US
85596006	SNOMEDCT_US
2321-07-5	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FLUORESCITE	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0092	INJECTION, SOLUTION	100 mg	OPHTHALMIC	NDA	19 sections
FLUORESCITE	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0092	INJECTION, SOLUTION	100 mg	OPHTHALMIC	NDA	19 sections
BioGlo	HUMAN PRESCRIPTION DRUG LABEL	1	17238-900	STRIP	1 mg	OPHTHALMIC	unapproved drug other	6 sections
BioGlo	HUMAN PRESCRIPTION DRUG LABEL	1	17238-900	STRIP	1 mg	OPHTHALMIC	unapproved drug other	6 sections
AK-FLUOR	HUMAN PRESCRIPTION DRUG LABEL	1	17478-250	INJECTION	250 mg	INTRAVENOUS	NDA	22 sections
AK-FLUOR	HUMAN PRESCRIPTION DRUG LABEL	1	17478-250	INJECTION	250 mg	INTRAVENOUS	NDA	22 sections
AK-FLUOR	HUMAN PRESCRIPTION DRUG LABEL	1	17478-253	INJECTION	100 mg	INTRAVENOUS	NDA	22 sections
AK-FLUOR	HUMAN PRESCRIPTION DRUG LABEL	1	17478-253	INJECTION	100 mg	INTRAVENOUS	NDA	22 sections
FUL-GLO	HUMAN PRESCRIPTION DRUG LABEL	1	17478-403	STRIP	0.60 mg	OPHTHALMIC	unapproved drug other	5 sections
FUL-GLO	HUMAN PRESCRIPTION DRUG LABEL	1	17478-403	STRIP	0.60 mg	OPHTHALMIC	unapproved drug other	5 sections
FUL-GLO	HUMAN PRESCRIPTION DRUG LABEL	1	17478-404	STRIP	1 mg	OPHTHALMIC	Unapproved drug other	6 sections
FUL-GLO	HUMAN PRESCRIPTION DRUG LABEL	1	17478-404	STRIP	1 mg	OPHTHALMIC	Unapproved drug other	6 sections
FLURESS	HUMAN PRESCRIPTION DRUG LABEL	2	17478-640	SOLUTION/ DROPS	2.50 mg	OPHTHALMIC	unapproved drug other	15 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	24208-734	SOLUTION/ DROPS	2.60 mg	OPHTHALMIC	NDA	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	24208-734	SOLUTION/ DROPS	2.60 mg	OPHTHALMIC	NDA	21 sections
AK-FLUOR	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4535	INJECTION	100 mg	INTRAVENOUS	NDA	22 sections
FLUORESCEIN	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1533	INJECTION	100 mg	INTRAVENOUS	NDA	14 sections
GloStrips	HUMAN PRESCRIPTION DRUG LABEL	1	51801-003	STRIP	0.60 mg	OPHTHALMIC	UNAPPROVED DRUG OTHER	5 sections
Dry Eye Test	HUMAN PRESCRIPTION DRUG LABEL	1	51801-008	STRIP	0.12 mg	OPHTHALMIC	UNAPPROVED DRUG OTHER	7 sections
GloStrips	HUMAN PRESCRIPTION DRUG LABEL	1	51801-009	STRIP	1 mg	OPHTHALMIC	UNAPPROVED DRUG OTHER	6 sections
Flurox	HUMAN PRESCRIPTION DRUG LABEL	2	54799-508	SOLUTION	2.50 mg	OPHTHALMIC	unapproved drug other	12 sections
Fluorescein Sodium and Proparacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	59390-205	SOLUTION/ DROPS	2.50 mg	OPHTHALMIC	UNAPPROVED DRUG OTHER	10 sections
Fluorescein Sodium and Proparacaine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	59390-205	SOLUTION/ DROPS	2.50 mg	OPHTHALMIC	UNAPPROVED DRUG OTHER	10 sections
ALTAFLUOR	HUMAN PRESCRIPTION DRUG LABEL	2	59390-218	SOLUTION	2.50 mg	OPHTHALMIC	NDA	21 sections
ALTAFLUOR	HUMAN PRESCRIPTION DRUG LABEL	2	59390-218	SOLUTION	2.50 mg	OPHTHALMIC	NDA	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	68682-732	SOLUTION/ DROPS	2.60 mg	OPHTHALMIC	NDA authorized generic	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	82260-734	SOLUTION/ DROPS	2.60 mg	OPHTHALMIC	NDA authorized generic	21 sections