MedPath

Riboflavin

Generic Name
Riboflavin
Brand Names
Alertonic, Concept Ob, Irospan 24/6 Kit, Mvc-fluoride, Natafort, Pregvit, Tandem Plus, Vitafol-one
Drug Type
Small Molecule
Chemical Formula
C17H20N4O6
CAS Number
83-88-5
Unique Ingredient Identifier
TLM2976OFR

Overview

Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as flavin mononucleotide and flavin-adenine dinucleotide.

Indication

For the treatment of ariboflavinosis (vitamin B2 deficiency).

Associated Conditions

  • Ariboflavinosis
  • Beriberi
  • Constipation
  • Functional Gastrointestinal Disorders (FGID)
  • Joint Pain
  • Metabolic cardiomyopathy
  • Migraine
  • Myalgia
  • Neuropathic Pain
  • Peripheral neuritis
  • Peripheral paralysis
  • Vitamin B complex deficiency
  • Vitamin B1 deficiency
  • Vitamin Deficiency
  • Wernicke's encephalopathy

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
3 mg in 1 1
4/12/2022
CarWin Pharmaceutical Associates, LLC
15370-105
ORAL
1.3 mg in 1 1
1/10/2024
Method Pharmaceuticals, LLC
58657-164
ORAL
1.2 mg in 1 1
12/9/2023
Exeltis USA, Inc.
0642-7473
ORAL
1.8 mg in 1 1
2/14/2023
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
20 mg in 1 1
5/2/2014
Centurion Labs, LLC
23359-105
ORAL
3 mg in 1 1
1/22/2024
PureTek Corporation
59088-193
ORAL
3.4 mg in 1 1
1/11/2023
BonGeo Pharmaceuticals, Inc.
52796-174
ORAL
1.5 mg in 1 1
2/2/2024
Cameron Pharmaceuticals
42494-432
ORAL
1.2 mg in 1 1
9/18/2023
Carilion Materials Management
68151-2640
ORAL
3 mg in 1 1
4/1/2013

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
ENZYPLEX TABLET
SIN06211P
ENTERIC COATED TABLET
5 mg
5/3/1991
IBERET-FOLIC-500 TABLET
SIN05447P
TABLET, FILM COATED
6 mg
2/19/1991
FBC FILMTAB
SIN05814P
TABLET, FILM COATED
2 mg
5/3/1991
CERNEVIT FOR INJECTION
SIN11975P
INJECTION, POWDER, FOR SOLUTION
4.14 mg/vial
6/5/2002

NMPA Drug Approvals

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

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
Men's Multi
326959
Medicine
A
12/2/2019
Super B Complex tablets
126510
Medicine
A
3/28/2006
BLACKMORES SUPERKIDS MULTI CHEWABLES
289492
Medicine
A
5/30/2017
BLACKMORES B+C TABLETS
215811
Medicine
A
10/9/2013
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
MaxN-Fuze Multivitamins
288444
Max Health & Living Australia Pty Ltd
Medicine
A
5/1/2017
Berocca Performance Original effervescent tablets
193893
Medicine
A
1/17/2012

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CENTURY PLUS
vita health products inc
N/A
Tablet - Oral
3.2 MG / TAB
2/5/1998
STRESS B COMPLEX WITH C AND E TAB
02008947
Tablet - Oral
10 MG / TAB
12/31/1993
STRESS B CAPSULES WITH VITAMIN C
rheingold food international ltd.
00694509
Capsule - Oral
50 MG / CAP
12/31/1987
MULTIPLE VITAMINS PLUS IRON FOR WOMEN
pharmetics (2011) inc
02239678
Tablet - Oral
1.7 MG / TAB
8/16/1999
MOR-VITES TAB
pharmetics (2011) inc
01911236
Tablet - Oral
3 MG
12/31/1992
B2 TAB 100MG
vita health products inc
00450650
Tablet - Oral
100 MG
12/31/1979
VITAMIN B2 100MG
great earth companies, inc.
02230623
Tablet - Oral
100 MG
8/25/1998
LIQUI B COMPLEX PLUS
twin laboratories inc.
01984411
Liquid - Oral
10 MG / ML
12/31/1995
POLYMINE AVEC ZINC ET CUIVRE
les laboratoires vachon inc.
00630888
Tablet - Oral
10 MG
12/31/1985
Q.T. #4 VITAMIN AND MINERAL DIETARY SUPPLEMENT
garden state nutritionals
02238953
Tablet - Oral
0.57 MG
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
BECOZYME C FORTE COMPRIMIDOS RECUBIERTOS
Bayer Hispania S.L.
40869
COMPRIMIDO RECUBIERTO
Sin Receta
Commercialized
ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA
Bayer Hispania S.L.
67267
COMPRIMIDO RECUBIERTO CON PELÍCULA
Sin Receta
Not Commercialized
HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES
Laboratorios Menarini S.A.
44019
COMPRIMIDO MASTICABLE
Sin Receta
Not Commercialized
HIDROPOLIVIT GOTAS ORALES EN SOLUCION
Laboratorios Menarini S.A.
44000
GOTAS ORALES EN SOLUCIÓN
Sin Receta
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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