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Biotin

Generic Name
Biotin
Brand Names
Concept Ob, Infuvite, Infuvite Pediatric, Irospan 24/6 Kit, Mvi Pediatric
Drug Type
Small Molecule
Chemical Formula
C10H16N2O3S
CAS Number
58-85-5
Unique Ingredient Identifier
6SO6U10H04

Overview

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.

Background

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.

Indication

For nutritional supplementation, also for treating dietary shortage or imbalance.

Associated Conditions

  • Vitamin Deficiency

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Shenzhen Joyuflsh Technology Co.,Ltd.
83766-106
TOPICAL
0.5 g in 100 mL
5/26/2025
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
150 ug in 1 1
5/2/2014
BonGeo Pharmaceuticals, Inc.
52796-174
ORAL
40 ug in 1 1
2/2/2024
Sandoz Inc
54643-9023
INTRAVENOUS
20 ug in 5 mL
10/28/2016
Sandoz Inc
54643-9015
INTRAVENOUS
60 ug in 10 mL
10/28/2016
Trivia Pharmaceuticals, LLC
84781-012
ORAL
30 ug in 1 1
6/23/2025
Avion Pharmaceuticals, LLC
75854-313
ORAL
280 ug in 1 1
1/7/2021
Hillestad Pharmaceuticals USA
10542-009
ORAL
300 ug in 1 1
10/24/2019
Carilion Materials Management
68151-1928
ORAL
150 ug in 1 1
11/11/2013
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
73317-8242
ORAL
150 ug in 1 1
9/25/2020

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
TAMIPOOL FOR INJECTION
SIN11849P
INJECTION, POWDER, FOR SOLUTION
60 mcg/vial
3/15/2002
CERNEVIT FOR INJECTION
SIN11975P
INJECTION, POWDER, FOR SOLUTION
0.069 mg/vial
6/5/2002
SOLUVIT N FOR INFUSION
SIN05209P
INJECTION, POWDER, FOR SOLUTION
60 mcg/vial
11/14/1990

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
CERNEVIT FOR INJ
N/A
N/A
N/A
4/18/2008
BIHAKU TAB
N/A
N/A
N/A
7/1/1994
HUAZIN INJ
N/A
N/A
N/A
4/28/1982

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Energy Multi
453128
Medicine
A
6/21/2024
Cellula-T oral powder jar
43995
Hong Sp & Hs
Medicine
A
4/13/1993
BLACKMORES SUPERKIDS MULTI CHEWABLES
289492
Medicine
A
5/30/2017
Super B Complex tablets
126510
Medicine
A
3/28/2006
MaxN-Fuze Multivitamins
288444
Max Health & Living Australia Pty Ltd
Medicine
A
5/1/2017
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs
139048
Medicine
A
5/21/2007
Caruso's Hair Food
130857
Medicine
A
8/30/2006
Berocca Performance Original effervescent tablets
193893
Medicine
A
1/17/2012
Threshold Controlled B-Complex
276600
Medicine
A
6/15/2016
Men's Multi
326959
Medicine
A
12/2/2019
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