Isoniazid
Isoniazid, Rifamate, Rifater (isoniazid) is a small molecule pharmaceutical. Isoniazid was first approved as Nydrazid on 1982-01-01. It is used to treat mycobacterium infections and tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Isoniazid (discontinued: Dow-isoniazid, Hyzyd, Inh, Isoniazid, Laniazid, Nydrazid, Rimifon, Stanozide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isoniazid
Tradename
Company
Number
Date
Products
NYDRAZIDBristol Myers SquibbN-008392 DISCN1982-01-01
1 products
ISONIAZIDEpic PharmaN-008678 DISCN1982-01-01
2 products, RLD
ISONIAZIDEli LillyN-008499 DISCN1982-01-01
2 products
ISONIAZIDPanray CorporationN-008428 DISCN1982-01-01
3 products
RIMIFONRocheN-008420 DISCN1982-01-01
3 products
NYDRAZIDSandozN-008662 DISCN1982-01-01
1 products
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Isoniazid
+
Pyrazinamide
+
Rifampin
Tradename
Company
Number
Date
Products
RIFATERSanofiN-050705 DISCN1994-05-31
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
albuterol sulfate inhalation solutionANDA2024-12-17
albuterol sulfate inhalation solution, 0.5%ANDA2025-03-24
ammoniaunapproved drug other2021-09-02
ammonia inhalantunapproved drug other2020-04-27
ammonia inhalantsunapproved drug other2024-10-28
amoray premium vaporizing inhalerOTC monograph final2016-03-31
arformoterol tartrate inhalationANDA2023-01-24
arformoterol tartrate inhalation solutionANDA2025-02-11
berinertBiologic Licensing Application2009-11-10
budesonideANDA2025-02-10
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J04: Antimycobacterials
J04A: Drugs for treatment of tuberculosis
J04AC: Hydrazides for tuberculosis treatment
J04AC01: Isoniazid
J04AC51: Isoniazid, combinations
J04AM: Combinations of drugs for treatment of tuberculosis
J04AM01: Streptomycin and isoniazid
J04AM02: Rifampicin and isoniazid
J04AM03: Ethambutol and isoniazid
J04AM04: Thioacetazone and isoniazid
J04AM05: Rifampicin, pyrazinamide and isoniazid
J04AM06: Rifampicin, pyrazinamide, ethambutol and isoniazid
J04AM07: Rifampicin, ethambutol and isoniazid
J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
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Clinical
Clinical Trials
379 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A191415
Pulmonary tuberculosisD014397EFO_1000049A15213
Hemophilia aD006467EFO_0007267D6611
Hemophilia bD002836D6711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Latent tuberculosisD055985Z22.7111
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIsoniazid
INNisoniazid
Description
Isoniazide is a carbohydrazide obtained by formal condensation between pyridine-4-carboxylic acid and hydrazine. It has a role as an antitubercular agent and a drug allergen. It is functionally related to an isonicotinic acid.
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Classification
Small molecule
Drug class
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Structure (InChI/SMILES or Protein Sequence)
NNC(=O)c1ccncc1
Identifiers
PDB
CAS-ID54-85-3
RxCUI
ChEMBL IDCHEMBL64
ChEBI ID6030
PubChem CID3767
DrugBankDB00951
UNII IDV83O1VOZ8L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Isoniazid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 57,384 documents
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Safety
Black-box Warning
Black-box warning for: Feiba, Isoniazid, Provocholine, Provocholine provocholine inhalation solution
Adverse Events
Top Adverse Reactions
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46,962 adverse events reported
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