Ranitidine
Zantac (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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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 300 | GSK | N-018703 DISCN | 1985-12-09 | 1 products, RLD |
| ZANTAC 150 | GSK | N-018703 DISCN | 1983-06-09 | 1 products, RLD |
| ZANTAC | GSK | N-019675 DISCN | 1988-12-30 | 1 products, RLD |
| ZANTAC 25 | GSK | N-020251 DISCN | 2004-04-01 | 1 products |
| ZANTAC 150 | GSK | N-020251 DISCN | 1994-03-31 | 2 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 |
|---|---|---|
| ranitidine | ANDA | 2023-01-27 |
| zantac 360 cool mint | ANDA | 2022-12-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duodenal ulcer | EFO_0004607 | D004381 | K26 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| peptic esophagitis | EFO_1001095 | D004942 | — |
| stomach ulcer | — | D013276 | K25 |
| zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
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Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2780 | Injection, ranitidine hydrochloride, 25 mg |
Clinical
Clinical Trials
60 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 1 | 1 | — | 1 | — | 3 | |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 2 | 1 | 3 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | 1 | — | — | 1 | — | 2 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 2 | — | 2 | |
| Drug interactions | D004347 | 1 | — | — | 1 | — | 2 | ||
| Prostatic neoplasms | D011471 | C61 | — | — | — | 1 | — | 1 | |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | — | 1 | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | 1 | — | 1 |
| Postoperative pain | D010149 | G89.18 | — | — | — | 1 | — | 1 | |
| Intestinal pseudo-obstruction | D007418 | EFO_1000988 | K56.0 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | 1 | 3 | — | 1 | 5 |
| Stomach ulcer | D013276 | K25 | — | — | 3 | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 1 | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | — | 1 |
| Cough | D003371 | HP_0012735 | R05 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | — | — | — | 2 |
| Immune system diseases | D007154 | D89.9 | 1 | 1 | — | — | — | 1 | |
| Renal cell carcinoma | D002292 | — | 1 | — | — | — | 1 | ||
| Postpartum hemorrhage | D006473 | O72 | — | 1 | — | — | — | 1 | |
| Job syndrome | D007589 | EFO_0003775 | D82.4 | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | C90.0 | — | 1 | — | — | — | 1 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | — | — | — | 1 |
| Blood protein disorders | D001796 | — | 1 | — | — | — | 1 | ||
| Plasma cell neoplasms | D054219 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 8 | — | — | — | — | 8 | ||
| Pharmacokinetics | D010599 | 3 | — | — | — | 1 | 4 | ||
| 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 | ||
| Pure autonomic failure | D054970 | 1 | — | — | — | — | 1 | ||
| Orthostatic hypotension | D007024 | I95.1 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory sounds | D012135 | HP_0010307 | R06.1 | — | — | — | — | 1 | 1 |
| Laryngomalacia | D055092 | HP_0001601 | — | — | — | — | 1 | 1 | |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | 1 | 1 | ||
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | 1 | 1 |
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) |
Target
Variants
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Financial
Ranitidine - Amneal Pharmaceuticals
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Trends
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Safety
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Adverse Events
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510 adverse events reported
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