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 |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
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 75 | Sanofi | N-020520 DISCN | 1995-12-19 | 1 products, RLD |
| ZANTAC 75 | Sanofi | N-020745 DISCN | 1998-02-26 | 1 products, RLD |
| ZANTAC 150 | Sanofi | N-021698 DISCN | 2004-08-31 | 2 products, RLD |
| ZANTAC 150 | GSK | N-018703 DISCN | 1983-06-09 | 1 products, RLD |
| ZANTAC 300 | GSK | N-018703 DISCN | 1985-12-09 | 1 products, RLD |
| ZANTAC | GSK | N-019675 DISCN | 1988-12-30 | 1 products, RLD |
| ZANTAC 150 | GSK | N-020251 DISCN | 1994-03-31 | 2 products |
| ZANTAC 25 | GSK | N-020251 DISCN | 2004-04-01 | 1 products |
| ZANTAC 150 | GSK | N-020095 DISCN | 1994-03-08 | 1 products, RLD |
| ZANTAC 300 | GSK | N-020095 DISCN | 1994-03-08 | 1 products, RLD |
| ZANTAC | PAI Pharma | N-019090 DISCN | 1984-10-19 | 1 products, RLD |
| ZANTAC IN PLASTIC CONTAINER | PAI Pharma | N-019593 DISCN | 1986-12-17 | 2 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acid reducer | ANDA | 2014-12-10 |
| aptidine | ANDA | 2013-02-21 |
| deramsilkrx anodynexa pak | ANDA | 2015-07-13 |
| dermasilkrx diclopak | ANDA | 2015-08-05 |
| equaline | ANDA | 2015-04-01 |
| gabitidine | unapproved drug other | 2011-08-01 |
| inflammation reduction pack | ANDA | 2015-11-18 |
| ranitidine | ANDA | 2025-05-23 |
| ranitidine - acid reducer | ANDA | 2015-10-06 |
| ranitidine hydrochloride | ANDA | 2020-08-18 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J2780 | Injection, ranitidine hydrochloride, 25 mg |
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | 1 | 3 | 1 | 2 | 7 |
| Neoplasms | D009369 | — | C80 | 3 | 3 | — | 1 | — | 6 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 3 | 2 | 5 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 3 | 2 | — | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | 1 | — | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | 1 | 1 | 3 |
| Vomiting | D014839 | — | R11.1 | — | — | — | 1 | 1 | 2 |
| Nausea | D009325 | — | R11.0 | — | — | — | 1 | 1 | 2 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | — | 2 |
| Pleural effusion | D010996 | — | J90 | — | 1 | — | 1 | — | 2 |
Show 26 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 4 | 1 | — | 1 | 5 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 1 | — | 3 | — | — | 4 |
| Esophageal neoplasms | D004938 | — | C15 | — | 2 | 1 | — | — | 3 |
| Stomach ulcer | D013276 | — | K25 | — | — | 3 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 1 | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | — | — | 1 | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | 1 | 1 | — | — | 1 |
| Cough | D003371 | — | R05 | — | — | 1 | — | — | 1 |
| Bronchial hyperreactivity | D016535 | — | — | — | — | 1 | — | — | 1 |
| Metaplasia | D008679 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 2 | 1 | — | — | 1 | 4 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 1 | — | — | 1 | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 3 | — | — | — | 3 |
| Peritoneal neoplasms | D010534 | — | — | 1 | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | — | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 2 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 2 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | — | 2 |
Show 37 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Covid-19 | D000086382 | — | U07.1 | 1 | — | — | — | 1 | 2 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | — | — | — | 1 | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | — | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
Show 12 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Surgical anastomosis | D000714 | — | — | — | — | — | — | 2 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Respiratory sounds | D012135 | — | R06.1 | — | — | — | — | 1 | 1 |
Show 15 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ranitidine |
| INN | ranitidine |
| 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 class | H2-receptor antagonists (cimetidine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC(=C[N+](=O)[O-])NCCSCc1ccc(CN(C)C)o1 |
Identifiers
| PDB | — |
| CAS-ID | 66357-35-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1790041 |
| ChEBI ID | — |
| PubChem CID | 3001055 |
| DrugBank | DB00863 |
| UNII ID | 884KT10YB7 (ChemIDplus, GSRS) |
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Ranitidine – Amneal Pharmaceuticals
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Ranitidine
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Trends
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Safety
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Adverse Events
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429,979 adverse events reported
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