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Isoniazid

Generic Name
Isoniazid
Brand Names
Isonarif, Isotamine, Isotamine B, Rifamate, Rifater
Drug Type
Small Molecule
Chemical Formula
C6H7N3O
CAS Number
54-85-3
Unique Ingredient Identifier
V83O1VOZ8L

Overview

Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

Indication

Isoniazid is used for the treatment of all forms of tuberculosis in which organisms are susceptible. It is also used in combination with rifampin and pyrazinamide.

Associated Conditions

  • Active Tuberculosis
  • Mycobacterium kansasii infection
  • Late phase Tuberculosis

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Blenheim Pharmacal, Inc.
10544-218
ORAL
300 mg in 1 1
4/20/2010
Physicians Total Care, Inc.
54868-2416
ORAL
300 mg in 1 1
3/4/2013
Department of State Health Services, Pharmacy Branch
55695-033
ORAL
300 mg in 1 1
3/11/2016
Rebel Distributors Corp
21695-627
ORAL
300 mg in 1 1
1/20/2010
Contract Pharmacy Services-PA
67046-333
ORAL
300 mg in 1 1
10/20/2006
Sandoz Inc
0781-3056
INTRAMUSCULAR
100 mg in 1 mL
10/11/2022
VersaPharm Incorporated
61748-016
ORAL
100 mg in 1 1
8/12/2010
Liberty Pharmaceuticals, Inc.
0440-1655
ORAL
300 mg in 1 1
4/3/2014
H.J. Harkins Company, Inc.
52959-145
ORAL
300 mg in 1 1
1/20/2010
Aphena Pharma Solutions - Tennessee, LLC
71610-395
ORAL
300 mg in 1 1
3/23/2020

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
PDP-ISONIAZID TABLET 300 mg
SIN06651P
TABLET
300 mg
10/29/1991
ISONIAZID TABLET 100 mg
ATLANTIC LABORATORIES CORPN LTD
SIN01302P
TABLET
100 mg
5/19/1988

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
PHARMASERVE INAH TAB 100MG
N/A
N/A
N/A
2/16/1995

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
NOUMED ISONIAZID 100mg tablet bottle
483125
Medicine
A
3/19/2025
ISONIAZID 100mg tablet bottle
13455
Medicine
A
8/30/1991
Rifinah 300/150mg
345792
Medicine
A
10/12/2020

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-ISONIAZID
02514907
Tablet - Oral
100 MG
N/A
PDP-ISONIAZID
pendopharm division of pharmascience inc
00577790
Tablet - Oral
100 MG
12/31/1984
ISONIAZID TAB 300MG
sands pharm
00310247
Tablet - Oral
300 MG / TAB
12/31/1974
ISONIAZID SYRUP 50MG/5ML
carolina medical products company
00722464
Syrup - Oral
50 MG / 5 ML
12/31/1987
ISOTAMINE
bausch health, canada inc.
00261289
Powder - Oral
500 G / BOTTLE
12/31/1976
PMS-ISONIAZID
02514893
Tablet - Oral
50 MG
N/A
PMS-ISONIAZID
02514923
Solution - Oral
50 MG / 5 ML
N/A
ISOTAMINE
bausch health, canada inc.
00261270
Tablet - Oral
100 MG
12/31/1972
ISOTAMINE B 300
bausch health, canada inc.
00236799
Tablet - Oral
300 MG
12/31/1967
ISONIAZIDE 100MG TABLETS
02232756
Tablet - Oral
100 MG / TAB
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CEMIDON B6 300 MG/50 MG COMPRIMIDOS
Chiesi España S.A.U.
63335
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
RIFINAH 300 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA
Sanofi Aventis S.A.
54213
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
CEMIDON B6 150 MG/25 MG COMPRIMIDOS
Chiesi España S.A.U.
40689
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
CEMIDON B6 50 MG/15 MG COMPRIMIDOS
Chiesi España S.A.U.
38394
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
RIMSTAR COMPRIMIDOS RECUBIERTOS CON PELICULA
65904
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
CEMIDON 60 MG/ML SOLUCIÓN INYECTABLE
Chiesi España S.A.U.
18697
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
RIFATER COMPRIMIDOS RECUBIERTOS
Sanofi Aventis S.A.
58299
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
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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