biotin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	373	58-85-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: biotin coenzyme R D-Biotin	A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk. Molecular weight: 244.31 Formula: C10H16N2O3S CLOGP: -0.08 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 78.43 ALOGS: -2.30 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

biotin
coenzyme R
D-Biotin

A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.

Molecular weight: 244.31
Formula: C10H16N2O3S
CLOGP: -0.08
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 78.43
ALOGS: -2.30
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.22 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	43 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Feb. 20, 1953	FDA	HOSPIRA

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

Source	Code	Description
ATC	A11HA05	ALIMENTARY TRACT AND METABOLISM VITAMINS OTHER PLAIN VITAMIN PREPARATIONS Other plain vitamin preparations
CHEBI has role	CHEBI:75769	B vitamin
CHEBI has role	CHEBI:50733	nutraceutical
MeSH PA	D018977	Micronutrients
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Biotin deficiency disease	indication	49607006
Biotinidase deficiency	off-label use	8808004	DOID:856
Propionic acidemia	off-label use	69080001	DOID:14701
Holocarboxylase synthase deficiency	off-label use	360369003	DOID:859
Constipation	contraindication	14760008	DOID:2089
Sarcoidosis	contraindication	31541009	DOID:11335
Dehydration	contraindication	34095006
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Kidney disease	contraindication	90708001	DOID:557
Kidney stone	contraindication	95570007
Osteolysis	contraindication	203522001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.79	acidic
pKa2	13.37	acidic

Orange Book patent data (new drug applications)

None

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
Insulin-degrading enzyme	Enzyme	P14735	IDE_HUMAN		EC50	5.60		CHEMBL

External reference:

ID	Source
D001710	MESH_DESCRIPTOR_UI
4017638	VUID
N0000146018	NUI
C0005575	UMLSCUI
D00029	KEGG_DRUG
6SO6U10H04	UNII
1203	INN_ID
13813003	SNOMEDCT_US
8919000	SNOMEDCT_US
4017638	VANDF
118935	MMSL
11819	MMSL
d06867	MMSL
001035	NDDF
1588	RXNORM
171548	PUBCHEM_CID
CHEBI:15956	CHEBI
CHEMBL857	ChEMBL_ID
DB00121	DRUGBANK_ID
BTN	PDB_CHEM_ID
4787	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Strovite Forte	HUMAN PRESCRIPTION DRUG LABEL	11	0642-0204	TABLET, COATED	0.15 mg	ORAL	UNAPPROVED DRUG OTHER	11 sections
Strovite One	HUMAN PRESCRIPTION DRUG LABEL	17	0642-0207	TABLET	100 ug	ORAL	UNAPPROVED DRUG OTHER	10 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	15	0682-3001	TABLET, COATED	150 ug	ORAL	UNAPPROVED DRUG OTHER	9 sections
Dialyvite Supreme D	HUMAN PRESCRIPTION DRUG LABEL	10	10542-009	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite	HUMAN PRESCRIPTION DRUG LABEL	8	10542-010	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite 5000	HUMAN PRESCRIPTION DRUG LABEL	9	10542-011	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite with Zinc	HUMAN PRESCRIPTION DRUG LABEL	8	10542-012	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Dialyvite 3000	HUMAN PRESCRIPTION DRUG LABEL	9	10542-014	TABLET, COATED	300 ug	ORAL	Unapproved drug other	7 sections
Quflora FE Pediatric Drops	HUMAN PRESCRIPTION DRUG LABEL	12	15370-102	LIQUID	3 ug	ORAL	UNAPPROVED DRUG OTHER	8 sections
Dialyvite	HUMAN PRESCRIPTION DRUG LABEL	8	17856-0010	TABLET, COATED	300 ug	ORAL	Unapproved drug other	8 sections
PNV-Select	HUMAN PRESCRIPTION DRUG LABEL	17	42192-320	TABLET, FILM COATED	300 ug	ORAL	unapproved drug other	11 sections
PNV-Omega	HUMAN PRESCRIPTION DRUG LABEL	13	42192-332	CAPSULE, GELATIN COATED	250 ug	ORAL	unapproved drug other	9 sections
HairQ-Plus	HUMAN OTC DRUG LABEL	1	49658-2001	SHAMPOO	0.06 mL	TOPICAL	unapproved drug other	7 sections
HairQ-Plus	HUMAN OTC DRUG LABEL	1	49658-4001	SOLUTION	0.06 mL	TOPICAL	unapproved drug other	7 sections
Bonogen	HUMAN OTC DRUG LABEL	3	50653-1001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	1 sections
Bonogen Plus	HUMAN OTC DRUG LABEL	3	50653-2001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	1 sections
Bonogen Activator	HUMAN OTC DRUG LABEL	1	50653-3001	LIQUID	0.00 mL	TOPICAL	unapproved drug other	1 sections
Born Hair	HUMAN OTC DRUG LABEL	3	50653-4001	SHAMPOO	0.06 g	TOPICAL	unapproved drug other	7 sections
IROSPAN 24/6	HUMAN PRESCRIPTION DRUG LABEL	20	50967-126	KIT	300 ug	None	unapproved drug other	9 sections
IROSPAN 24/6	HUMAN PRESCRIPTION DRUG LABEL	20	50967-126	KIT	300 ug	None	unapproved drug other	9 sections
Doll Lash	HUMAN OTC DRUG LABEL	3	51329-1001	LIQUID	0.06 mL	TOPICAL	unapproved drug other	7 sections
Concept OB	HUMAN PRESCRIPTION DRUG LABEL	15	52747-620	CAPSULE	300 ug	ORAL	unapproved drug other	1 sections
Concept DHA	HUMAN PRESCRIPTION DRUG LABEL	14	52747-621	CAPSULE, LIQUID FILLED	300 ug	ORAL	unapproved drug other	1 sections
Integra Plus	HUMAN PRESCRIPTION DRUG LABEL	9	52747-712	CAPSULE	300 ug	ORAL	unapproved drug other	2 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	15	52796-173	TABLET, CHEWABLE	40 ug	ORAL	UNAPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	15	52796-174	TABLET, CHEWABLE	40 ug	ORAL	UNAPPROVED DRUG OTHER	6 sections
Floriva	HUMAN PRESCRIPTION DRUG LABEL	15	52796-177	TABLET, CHEWABLE	40 ug	ORAL	UNAPPROVED DRUG OTHER	7 sections
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION	HUMAN PRESCRIPTION DRUG LABEL	12	54643-5646	INJECTION, SOLUTION	20 ug	INTRAVENOUS	NDA	14 sections
Pediatric Infuvite Multiple Vitamins	HUMAN PRESCRIPTION DRUG LABEL	12	54643-5647	KIT	20 ug	None	NDA	14 sections
Adult Infuvite Multiple Vitamins for Infusion	HUMAN PRESCRIPTION DRUG LABEL	13	54643-5649	INJECTION, SOLUTION	60 ug	INTRAVENOUS	NDA	11 sections