Stem definition | Drug id | CAS RN |
---|---|---|
1948 | 10102-43-9 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 23, 1999 | FDA | INO |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Intraventricular haemorrhage neonatal | 140.71 | 53.43 | 19 | 1318 | 143 | 50603644 |
Oxygen saturation decreased | 108.87 | 53.43 | 48 | 1289 | 73200 | 50530587 |
Device failure | 83.64 | 53.43 | 21 | 1316 | 5507 | 50598280 |
Patent ductus arteriosus | 75.53 | 53.43 | 18 | 1319 | 3802 | 50599985 |
Product use issue | 57.06 | 53.43 | 40 | 1297 | 149435 | 50454352 |
Pneumothorax | 56.30 | 53.43 | 19 | 1318 | 14015 | 50589772 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Product use issue | 141.13 | 59.37 | 62 | 1368 | 51382 | 29521715 |
Oxygen saturation decreased | 109.78 | 59.37 | 50 | 1380 | 44887 | 29528210 |
Device delivery system issue | 94.48 | 59.37 | 16 | 1414 | 318 | 29572779 |
No adverse event | 89.15 | 59.37 | 33 | 1397 | 17445 | 29555652 |
Neonatal disorder | 74.47 | 59.37 | 15 | 1415 | 788 | 29572309 |
Off label use | 70.72 | 59.37 | 79 | 1351 | 300721 | 29272376 |
Device issue | 68.05 | 59.37 | 22 | 1408 | 7758 | 29565339 |
Hypertrophic cardiomyopathy | 67.27 | 59.37 | 14 | 1416 | 865 | 29572232 |
Device failure | 65.80 | 59.37 | 16 | 1414 | 2000 | 29571097 |
Pulmonary haemorrhage | 64.27 | 59.37 | 22 | 1408 | 9248 | 29563849 |
Product use in unapproved indication | 64.12 | 59.37 | 44 | 1386 | 86831 | 29486266 |
Pulmonary hypertension | 62.58 | 59.37 | 26 | 1404 | 18582 | 29554515 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Product use issue | 206.26 | 51.81 | 95 | 1721 | 151620 | 64345296 |
Product use in unapproved indication | 118.60 | 51.81 | 69 | 1747 | 176549 | 64320367 |
Oxygen saturation decreased | 111.37 | 51.81 | 56 | 1760 | 107120 | 64389796 |
Off label use | 101.22 | 51.81 | 105 | 1711 | 632701 | 63864215 |
Device failure | 71.99 | 51.81 | 19 | 1797 | 5673 | 64491243 |
Right ventricular failure | 68.82 | 51.81 | 25 | 1791 | 21446 | 64475470 |
Cardiac arrest | 62.72 | 51.81 | 44 | 1772 | 154020 | 64342896 |
Pulmonary arterial hypertension | 57.71 | 51.81 | 23 | 1793 | 25344 | 64471572 |
Pulmonary hypertension | 55.04 | 51.81 | 26 | 1790 | 43113 | 64453803 |
None
Source | Code | Description |
---|---|---|
ATC | R07AX01 | RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products |
FDA PE | N0000009909 | Vasodilation |
MeSH PA | D018927 | Anti-Asthmatic Agents |
MeSH PA | D000975 | Antioxidants |
MeSH PA | D001993 | Bronchodilator Agents |
MeSH PA | D002317 | Cardiovascular Agents |
MeSH PA | D045462 | Endothelium-Dependent Relaxing Factors |
MeSH PA | D016166 | Free Radical Scavengers |
MeSH PA | D064426 | Gasotransmitters |
MeSH PA | D018377 | Neurotransmitter Agents |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D019141 | Respiratory System Agents |
MeSH PA | D014665 | Vasodilator Agents |
FDA EPC | N0000175940 | Vasodilator |
CHEBI has role | CHEBI:25512 | neurotransmitters |
CHEBI has role | CHEBI:35523 | bronchodilator |
CHEBI has role | CHEBI:35620 | vasodilator agents |
CHEBI has role | CHEBI:48578 | free radical scavengers |
CHEBI has role | CHEBI:62488 | signal molecules |
CHEBI has role | CHEBI:75771 | Mus musculus metabolites |
CHEBI has role | CHEBI:76971 | Escherichia coli metabolites |
CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Pulmonary hypertension | indication | 70995007 | DOID:6432 |
Persistent pulmonary hypertension of the newborn | indication | 233815004 | DOID:13042 |
Methemoglobinemia | contraindication | 38959009 | DOID:10783 |
Left heart failure | contraindication | 85232009 | |
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus | contraindication |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 10124142 | Aug. 18, 2025 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 8226916 | Aug. 18, 2025 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 8609028 | Aug. 18, 2025 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 9956373 | Aug. 18, 2025 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 10814092 | Oct. 17, 2025 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 8057742 | Jan. 18, 2026 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 7947227 | Oct. 17, 2026 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8282966 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8293284 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8431163 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8795741 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8846112 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8282966 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8293284 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8431163 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8795741 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8846112 | June 30, 2029 | A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE |
800PPM | GENOSYL | VERO BIOTECH | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 9604028 | Aug. 13, 2029 | A METHOD FOR DELIVERING NITRIC OXIDE TO A PATIENT WITH PULMONARY HYPERTENSION OR HYPOXIA |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8291904 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8573210 | Jan. 6, 2031 | A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8776794 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | DISCN | GAS | INHALATION | 8776795 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8291904 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8573210 | Jan. 6, 2031 | A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8776794 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 8776795 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9265911 | Jan. 6, 2031 | A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9295802 | Jan. 6, 2031 | A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9408993 | Jan. 6, 2031 | A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9279794 | Feb. 19, 2034 | A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY COMPENSATING LONG-TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS USED IN SYSTEMS FOR DELIVERING THERAPEUTIC NITRIC OXIDE TO A PATIENT |
800PPM | INOMAX | MALLINCKRODT HOSP | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9770570 | May 3, 2036 | A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY MEASURING AND DISPLAYING AN INDICATION OF THE CALCULATED DELIVERY CONCENTRATION OF NITIRIC OXIDE AS COMPARED TO THE DESIRED DELIVERY CONCENTRATION OF NITRIC OXIDE |
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Soluble guanylate cyclase | Enzyme | ACTIVATOR | CHEMBL | CHEMBL |
ID | Source |
---|---|
31C4KY9ESH | UNII |
4021248 | VUID |
N0000148689 | NUI |
D00074 | KEGG_DRUG |
4021248 | VANDF |
C0028128 | UMLSCUI |
CHEBI:16480 | CHEBI |
NO | PDB_CHEM_ID |
CHEMBL1200689 | ChEMBL_ID |
145068 | PUBCHEM_CID |
DB00435 | DRUGBANK_ID |
D009569 | MESH_DESCRIPTOR_UI |
405139 | RXNORM |
17479 | MMSL |
47106 | MMSL |
d04508 | MMSL |
012088 | NDDF |
409378005 | SNOMEDCT_US |
6710000 | SNOMEDCT_US |
CHEMBL1234579 | ChEMBL_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Noxivent 101 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59579-101 | GAS | 100 mg | RESPIRATORY (INHALATION) | ANDA | 16 sections |
Noxivent 102 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59579-102 | GAS | 800 mg | RESPIRATORY (INHALATION) | ANDA | 16 sections |
INOmax | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64693-002 | GAS | 0.98 mg | RESPIRATORY (INHALATION) | NDA | 23 sections |
Nitric Oxide Nitrogen Mix | HUMAN PRESCRIPTION DRUG LABEL | 2 | 67989-011 | GAS | 5 mL | RESPIRATORY (INHALATION) | unapproved medical gas | 1 sections |
GENOSYL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72385-001 | GAS | 0.98 mg | RESPIRATORY (INHALATION) | NDA | 23 sections |
NOW st | HUMAN OTC DRUG LABEL | 1 | 80519-301 | LIQUID | 1.12 g | TOPICAL | unapproved drug other | 12 sections |