MedPath

Nicotinamide

Generic Name
Nicotinamide
Brand Names
Alertonic, Fortaplex, Infuvite, Infuvite Pediatric, Mvc-fluoride, Mvi Pediatric, Natafort, Neo-bex, Nicomide, Pregvit, Tandem Plus
Drug Type
Small Molecule
Chemical Formula
C6H6N2O
CAS Number
98-92-0
Unique Ingredient Identifier
25X51I8RD4

Overview

An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Indication

用于防治糙皮病等烟酸缺乏病,也用于防治心脏传导阻滞。

Associated Conditions

  • Gastrointestinal insufficiency
  • Hepatic Insufficiency
  • Macrocytic anemia
  • Secondary anemia
  • Vitamin Deficiency
  • Severe debilitation

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/03
Not Applicable
Completed
Federal University of Rio Grande do Sul
2024/10/15
Phase 2
Recruiting
2024/09/19
Phase 2
Recruiting
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2024/06/20
Phase 2
Recruiting
University of Chile
2024/02/28
Phase 1
Recruiting
2023/08/23
Phase 2
Recruiting
University Hospital, Angers
2023/07/24
Phase 3
Completed
KRL Hospital, Islamabad
2023/07/21
Phase 3
Recruiting
2023/01/27
Early Phase 1
Not yet recruiting
2022/08/24
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
20 mg in 1 1
4/12/2022
Sincerus Florida, LLC
72934-1017
TOPICAL
2 g in 100 g
4/23/2019
CarWin Pharmaceutical Associates, LLC
15370-105
ORAL
5 mg in 1 1
1/10/2024
Sincerus Florida, LLC
72934-2166
TOPICAL
4 g in 100 g
5/13/2019
Sincerus Florida, LLC
72934-1066
TOPICAL
4 g in 100 g
4/23/2019
Sincerus Florida, LLC
72934-1200
TOPICAL
4 g in 100 g
7/2/2020
Exeltis USA, Inc.
0642-7473
ORAL
15 mg in 1 1
2/14/2023
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
100 mg in 1 1
5/2/2014
Sincerus Florida, LLC
72934-5069
TOPICAL
4 g in 100 g
5/22/2019
Sincerus Florida, LLC
72934-1088
TOPICAL
5 g in 100 g
5/17/2019

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
10 mg
5/3/1991
CERNEVIT FOR INJECTION
SIN11975P
INJECTION, POWDER, FOR SOLUTION
46 mg/vial
6/5/2002
IBERET-FOLIC-500 TABLET
SIN05447P
TABLET, FILM COATED
30 mg
2/19/1991
TAMIPOOL FOR INJECTION
SIN11849P
INJECTION, POWDER, FOR SOLUTION
40 mg/vial
3/15/2002
SOLUVIT N FOR INFUSION
SIN05209P
INJECTION, POWDER, FOR SOLUTION
40 mg/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
MULTIMAX SYRUP
N/A
N/A
N/A
7/8/2014
CERNEVIT FOR INJ
N/A
N/A
N/A
4/18/2008
BIOCATALIN INJECTABLE SOLN (VET)
N/A
N/A
N/A
8/9/1984
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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CENTURY PLUS
vita health products inc
N/A
Tablet - Oral
40 MG / TAB
2/5/1998
STRESS B CAPSULES WITH VITAMIN C
rheingold food international ltd.
00694509
Capsule - Oral
50 MG / CAP
12/31/1987
STRESS B WITH 1000 MG VITAMIN C
holista health (canada) inc.
02246252
Tablet - Oral
25 MG
11/13/2002
STRESS B PLUS VITAMINS & MINERALS
great earth companies, inc.
02231749
Tablet (Extended-Release) - Oral
160 MG / TAB
9/25/1998
MULTIPLE VITAMINS PLUS IRON FOR WOMEN
pharmetics (2011) inc
02239678
Tablet - Oral
20 MG / TAB
8/16/1999
MOR-VITES TAB
pharmetics (2011) inc
01911236
Tablet - Oral
20 MG
12/31/1992
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
100 MG
12/31/1985
MULTIVITAMINS AND MINERALS - FORTE
vita health products inc
02239947
Tablet - Oral
40 MG / TAB
2/1/2000
Q.T. #4 VITAMIN AND MINERAL DIETARY SUPPLEMENT
garden state nutritionals
02238953
Tablet - Oral
6 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
CERNEVIT POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN
Baxter S.L.
60022
LIOFILIZADO PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA
Bayer Hispania S.L.
67267
COMPRIMIDO RECUBIERTO CON PELÍCULA
Sin Receta
Not Commercialized
VIANT POLVO PARA SOLUCION PARA PERFUSION
83664
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES
Laboratorios Menarini S.A.
44019
COMPRIMIDO MASTICABLE
Sin Receta
Not Commercialized
SOLUVIT LIOFILIZADO PARA SOLUCION PARA PERFUSION
Fresenius Kabi España, S.A.U.
61228
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
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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