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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1948 | 10102-43-9 |
None
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 23, 1999 | FDA | INO | |
| Aug. 1, 2001 | EMA | LINDE HEALTHCARE AB |
| 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 |
|---|---|---|---|---|---|---|
| Vitamin B1 decreased | 192.87 | 67.11 | 30 | 2988 | 508 | 90624921 |
| Blood lactic acid decreased | 183.57 | 67.11 | 28 | 2990 | 414 | 90625015 |
| Oxygen saturation decreased | 176.25 | 67.11 | 81 | 2937 | 107402 | 90518027 |
| Hypoxia | 175.78 | 67.11 | 72 | 2946 | 72327 | 90553102 |
| Cardiac output increased | 170.77 | 67.11 | 27 | 2991 | 510 | 90624919 |
| Intraventricular haemorrhage neonatal | 134.15 | 67.11 | 20 | 2998 | 251 | 90625178 |
| Product use issue | 130.93 | 67.11 | 99 | 2919 | 329820 | 90295609 |
| Patent ductus arteriosus | 123.55 | 67.11 | 29 | 2989 | 4540 | 90620889 |
| Hyperlactacidaemia | 115.77 | 67.11 | 27 | 2991 | 4109 | 90621320 |
| Pulmonary hypertensive crisis | 108.66 | 67.11 | 18 | 3000 | 459 | 90624970 |
| Vitamin B1 increased | 102.42 | 67.11 | 15 | 3003 | 165 | 90625264 |
| Device failure | 102.06 | 67.11 | 27 | 2991 | 6870 | 90618559 |
| Underdose | 98.77 | 67.11 | 44 | 2974 | 53973 | 90571456 |
| Electrocardiogram abnormal | 95.74 | 67.11 | 28 | 2990 | 10270 | 90615159 |
| Right ventricular failure | 94.01 | 67.11 | 32 | 2986 | 19173 | 90606256 |
| Bronchopulmonary dysplasia | 90.41 | 67.11 | 16 | 3002 | 608 | 90624821 |
| Premature delivery | 81.98 | 67.11 | 35 | 2983 | 38727 | 90586702 |
| Pulmonary hypertension | 78.87 | 67.11 | 35 | 2983 | 42488 | 90582941 |
| Pneumothorax | 78.64 | 67.11 | 28 | 2990 | 19139 | 90606290 |
| Pulmonary haemorrhage | 75.41 | 67.11 | 22 | 2996 | 7991 | 90617438 |
| 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 | 358.74 | 57.44 | 145 | 2502 | 76606 | 42542082 |
| Oxygen saturation decreased | 182.78 | 57.44 | 86 | 2561 | 64601 | 42554087 |
| Device delivery system issue | 136.24 | 57.44 | 27 | 2620 | 1010 | 42617678 |
| No adverse event | 132.38 | 57.44 | 59 | 2588 | 38962 | 42579726 |
| Underdose | 126.15 | 57.44 | 45 | 2602 | 16621 | 42602067 |
| Device issue | 108.00 | 57.44 | 38 | 2609 | 13471 | 42605217 |
| Pulmonary hypertension | 97.40 | 57.44 | 41 | 2606 | 23528 | 42595160 |
| Product use in unapproved indication | 83.93 | 57.44 | 78 | 2569 | 184378 | 42434310 |
| Neonatal hypotension | 83.89 | 57.44 | 14 | 2633 | 194 | 42618494 |
| Respiratory failure | 80.10 | 57.44 | 65 | 2582 | 128067 | 42490621 |
| Condition aggravated | 79.87 | 57.44 | 89 | 2558 | 260665 | 42358023 |
| Drug ineffective | 79.55 | 57.44 | 140 | 2507 | 630057 | 41988631 |
| Device failure | 70.81 | 57.44 | 19 | 2628 | 2724 | 42615964 |
| Neonatal disorder | 70.61 | 57.44 | 15 | 2632 | 792 | 42617896 |
| Hypertrophic cardiomyopathy | 66.85 | 57.44 | 16 | 2631 | 1449 | 42617239 |
| Device malfunction | 66.54 | 57.44 | 26 | 2621 | 12301 | 42606387 |
| Pulmonary haemorrhage | 64.93 | 57.44 | 25 | 2622 | 11372 | 42607316 |
| Pulmonary hypertensive crisis | 63.25 | 57.44 | 11 | 2636 | 197 | 42618491 |
| Off label use | 59.60 | 57.44 | 125 | 2522 | 638210 | 41980478 |
| Right ventricular failure | 58.16 | 57.44 | 22 | 2625 | 9533 | 42609155 |
| 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 | 443.22 | 54.92 | 218 | 3805 | 311477 | 110273799 |
| Oxygen saturation decreased | 219.49 | 54.92 | 109 | 3914 | 156873 | 110428403 |
| Vitamin B1 decreased | 173.48 | 54.92 | 30 | 3993 | 909 | 110584367 |
| Blood lactic acid decreased | 173.08 | 54.92 | 28 | 3995 | 560 | 110584716 |
| Hypoxia | 166.39 | 54.92 | 85 | 3938 | 129430 | 110455846 |
| Cardiac output increased | 164.88 | 54.92 | 27 | 3996 | 584 | 110584692 |
| Product use in unapproved indication | 158.04 | 54.92 | 130 | 3893 | 447247 | 110138029 |
| Right ventricular failure | 130.07 | 54.92 | 45 | 3978 | 25909 | 110559367 |
| Vitamin B1 increased | 101.08 | 54.92 | 15 | 4008 | 165 | 110585111 |
| Drug ineffective | 100.82 | 54.92 | 189 | 3834 | 1520351 | 109064925 |
| Respiratory failure | 100.56 | 54.92 | 74 | 3949 | 215258 | 110370018 |
| Cardiac arrest | 99.58 | 54.92 | 71 | 3952 | 196682 | 110388594 |
| Hyperlactacidaemia | 94.76 | 54.92 | 27 | 3996 | 8259 | 110577017 |
| Pulmonary hypertension | 94.04 | 54.92 | 44 | 3979 | 55176 | 110530100 |
| Off label use | 91.39 | 54.92 | 180 | 3843 | 1500005 | 109085271 |
| Pulmonary hypertensive crisis | 87.12 | 54.92 | 15 | 4008 | 442 | 110584834 |
| Device issue | 82.85 | 54.92 | 35 | 3988 | 34500 | 110550776 |
| Electrocardiogram abnormal | 80.59 | 54.92 | 29 | 3994 | 18680 | 110566596 |
| Device failure | 80.23 | 54.92 | 23 | 4000 | 7184 | 110578092 |
| Drug ineffective for unapproved indication | 78.47 | 54.92 | 48 | 3975 | 102790 | 110482486 |
| Premature delivery | 76.67 | 54.92 | 32 | 3991 | 30600 | 110554676 |
| Device delivery system issue | 69.37 | 54.92 | 16 | 4007 | 2117 | 110583159 |
| Pulmonary arterial pressure increased | 69.08 | 54.92 | 19 | 4004 | 5108 | 110580168 |
| Pulmonary arterial hypertension | 68.24 | 54.92 | 30 | 3993 | 32538 | 110552738 |
| Pulmonary congestion | 66.42 | 54.92 | 29 | 3994 | 30937 | 110554339 |
| Pulmonary haemorrhage | 65.26 | 54.92 | 24 | 3999 | 16432 | 110568844 |
| Condition aggravated | 63.40 | 54.92 | 103 | 3920 | 734733 | 109850543 |
| No adverse event | 62.88 | 54.92 | 37 | 3986 | 73802 | 110511474 |
| Pneumothorax | 56.61 | 54.92 | 27 | 3996 | 35258 | 110550018 |
| Hypotension | 55.75 | 54.92 | 81 | 3942 | 523768 | 110061508 |
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 | D000975 | Antioxidants |
| MeSH PA | D001993 | Bronchodilator Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D014665 | Vasodilator Agents |
| MeSH PA | D016166 | Free Radical Scavengers |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018927 | Anti-Asthmatic Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| MeSH PA | D045462 | Endothelium-Dependent Relaxing Factors |
| MeSH PA | D064426 | Gasotransmitters |
| FDA EPC | N0000175940 | Vasodilator |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:25512 | neurotransmitter |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
| CHEBI has role | CHEBI:35523 | bronchodilator agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:35718 | antifungal agent |
| CHEBI has role | CHEBI:38068 | antimalarial |
| CHEBI has role | CHEBI:48578 | radical scavenger |
| CHEBI has role | CHEBI:49201 | anti-ulcer drug |
| CHEBI has role | CHEBI:62488 | signalling molecule |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:70868 | antileishmanial agent |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| CHEBI has role | CHEBI:76971 | <em>Escherichia coli</em> metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:86327 | antifungal drug |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
| 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 INC | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 8057742 | Jan. 18, 2026 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
| 800PPM | GENOSYL | VERO BIOTECH INC | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 |
| 4880PPM | INOMAX | MALLINCKRODT IRELAND | N020845 | Jan. 17, 2023 | RX | GAS | INHALATION | 11931377 | June 30, 2029 | A METHOD FOR TREATING A PEDIATRIC PATIENT WHO IS EXPERIENCING IDIOPATHIC PULMONARY ARTERIAL HYPERTENSION RESULTING IN OXYGEN DESATURATION, WHEREIN THE PATIENT IS NOT DEPENDENT ON RIGHT-TO-LEFT SHUNTING OF BLOOD |
| 800PPM | INOMAX | MALLINCKRODT IRELAND | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 11931377 | June 30, 2029 | A METHOD FOR TREATING A PEDIATRIC PATIENT WHO IS EXPERIENCING IDIOPATHIC PULMONARY ARTERIAL HYPERTENSION RESULTING IN OXYGEN DESATURATION, WHEREIN THE PATIENT IS NOT DEPENDENT ON RIGHT-TO-LEFT SHUNTING OF BLOOD |
| 800PPM | INOMAX | MALLINCKRODT IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 INC | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | 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 IRELAND | N020845 | Dec. 23, 1999 | RX | GAS | INHALATION | 9279794 | Feb. 19, 2035 | 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 IRELAND | 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 NITRIC OXIDE AS COMPARED TO THE DESIRED DELIVERY CONCENTRATION OF NITRIC OXIDE |
| 800PPM | GENOSYL | VERO BIOTECH INC | N202860 | Dec. 20, 2019 | RX | GAS | INHALATION | 11672938 | July 22, 2040 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT |
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 |
| 31C4KY9ESH | INXIGHT DRUGS |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |
| INOMAX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64693-003 | GAS | 6 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 |
| GENOSYL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72385-002 | GAS | 0.98 mg | RESPIRATORY (INHALATION) | NDA | 26 sections |
| GENOSYL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72385-003 | GAS | 0.98 mg | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Noxivent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72385-102 | GAS | 800 mg | RESPIRATORY (INHALATION) | ANDA | 16 sections |
| NOW st | HUMAN OTC DRUG LABEL | 1 | 80519-301 | LIQUID | 1.12 g | TOPICAL | unapproved drug other | 12 sections |
| Ulspira | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82605-006 | GAS | 0.80 mL | RESPIRATORY (INHALATION) | ANDA | 15 sections |
| Ulspira | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82605-008 | GAS | 0.80 mL | RESPIRATORY (INHALATION) | ANDA | 2 sections |