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AboutPricing
Drug ReportsRanitidine
Ranitidine
Ranitidine (ranitidine) is a small molecule pharmaceutical. Ranitidine was first approved as Zantac 150 on 1983-06-09. It is used to treat duodenal ulcer, gastroesophageal reflux, peptic esophagitis, stomach ulcer, and zollinger-ellison syndrome in the USA. The pharmaceutical is active against histamine H2 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
Trade Name
FDA
EMA
Ranitidine (discontinued: Ranitidine, Tritec, Zantac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ranitidine hydrochloride
Tradename
Company
Number
Date
Products
ZANTAC 75SanofiN-020520 DISCN1995-12-19
1 products, RLD
ZANTAC 75SanofiN-020745 DISCN1998-02-26
1 products, RLD
ZANTAC 150SanofiN-021698 DISCN2004-08-31
2 products, RLD
ZANTAC 150GSKN-018703 DISCN1983-06-09
1 products, RLD
ZANTAC 300GSKN-018703 DISCN1985-12-09
1 products, RLD
ZANTACGSKN-019675 DISCN1988-12-30
1 products, RLD
ZANTAC 150GSKN-020251 DISCN1994-03-31
2 products
ZANTAC 25GSKN-020251 DISCN2004-04-01
1 products
ZANTAC 150GSKN-020095 DISCN1994-03-08
1 products, RLD
ZANTAC 300GSKN-020095 DISCN1994-03-08
1 products, RLD
ZANTACPAI PharmaN-019090 DISCN1984-10-19
1 products, RLD
ZANTAC IN PLASTIC CONTAINERPAI PharmaN-019593 DISCN1986-12-17
2 products
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Ranitidine bismuth citrate
Tradename
Company
Number
Date
Products
TRITECGSKN-020559 DISCN1996-08-08
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
acid reducerANDA2014-12-10
aptidineANDA2013-02-21
deramsilkrx anodynexa pakANDA2015-07-13
dermasilkrx diclopakANDA2015-08-05
equalineANDA2015-04-01
gabitidineunapproved drug other2011-08-01
inflammation reduction packANDA2015-11-18
ranitidineANDA2025-05-23
ranitidine - acid reducerANDA2015-10-06
ranitidine hydrochlorideANDA2020-08-18
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gastroesophageal refluxEFO_0003948D005764K21
peptic esophagitisEFO_1001095D004942—
stomach ulcer—D013276K25
duodenal ulcerEFO_0004607D004381K26
zollinger-ellison syndrome—D015043E16.4
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BA: H2-receptor antagonists
— A02BA02: Ranitidine
— A02BA07: Ranitidine bismuth citrate
HCPCS
Code
Description
J2780
Injection, ranitidine hydrochloride, 25 mg
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRanitidine
INNranitidine
Description
Ranitidine is a member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease. It has a role as an anti-ulcer drug, a H2-receptor antagonist, an environmental contaminant, a xenobiotic and a drug allergen. It is a member of furans, a tertiary amino compound, a C-nitro compound and an organic sulfide.
Classification
Small molecule
Drug classH2-receptor antagonists (cimetidine type)
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Structure (InChI/SMILES or Protein Sequence)
CNC(=C[N+](=O)[O-])NCCSCc1ccc(CN(C)C)o1
Identifiers
PDB—
CAS-ID66357-35-5
RxCUI—
ChEMBL IDCHEMBL1790041
ChEBI ID—
PubChem CID3001055
DrugBankDB00863
UNII ID884KT10YB7 (ChemIDplus, GSRS)
Target
Agency Approved
HRH2
HRH2
Organism
Homo sapiens
Gene name
HRH2
Gene synonyms
NCBI Gene ID
3274
Protein name
histamine H2 receptor
Protein synonyms
gastric receptor 1, Gastric receptor I
Uniprot ID
P25021
Mouse ortholog
Hrh2 (15466)
histamine H2 receptor (Q9D282)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Ranitidine – Amneal Pharmaceuticals
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Estimated US medical usage
Ranitidine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,002 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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429,979 adverse events reported
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