midazolam Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| diazepam derivatives | 1802 | 59467-70-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 15 | mg | O |
| 15 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 10.30 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 5.60 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.26 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 44 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.10 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 5.30 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.02 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 3.10 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 20, 1985 | FDA |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 579.54 | 60.10 | 257 | 1605 | 101367 | 2254856 |
| Hypotension | 444.92 | 60.10 | 156 | 1706 | 32280 | 2323943 |
| Cardiac arrest | 307.88 | 60.10 | 98 | 1764 | 14832 | 2341391 |
| Anaphylactic reaction | 299.81 | 60.10 | 87 | 1775 | 9618 | 2346605 |
| Status epilepticus | 212.05 | 60.10 | 50 | 1812 | 2428 | 2353795 |
| Toxicity to various agents | 196.38 | 60.10 | 87 | 1775 | 32667 | 2323556 |
| Tachycardia | 186.13 | 60.10 | 69 | 1793 | 16340 | 2339883 |
| Oxygen saturation decreased | 186.04 | 60.10 | 57 | 1805 | 7529 | 2348694 |
| Unresponsive to stimuli | 160.34 | 60.10 | 46 | 1816 | 4830 | 2351393 |
| Drug interaction | 154.05 | 60.10 | 71 | 1791 | 29092 | 2327131 |
| Bradycardia | 147.05 | 60.10 | 51 | 1811 | 9930 | 2346293 |
| Seizure | 143.15 | 60.10 | 64 | 1798 | 24402 | 2331821 |
| Exposure during pregnancy | 134.96 | 60.10 | 62 | 1800 | 25157 | 2331066 |
| Anaphylactic shock | 134.47 | 60.10 | 39 | 1823 | 4247 | 2351976 |
| Agitation | 130.74 | 60.10 | 48 | 1814 | 11003 | 2345220 |
| Intestinal ischaemia | 114.40 | 60.10 | 26 | 1836 | 1065 | 2355158 |
| Multiple organ dysfunction syndrome | 112.28 | 60.10 | 39 | 1823 | 7602 | 2348621 |
| Respiratory failure | 110.86 | 60.10 | 45 | 1817 | 13483 | 2342740 |
| Circulatory collapse | 108.50 | 60.10 | 32 | 1830 | 3688 | 2352535 |
| Hypoxia | 108.01 | 60.10 | 36 | 1826 | 6191 | 2350032 |
| Respiratory depression | 106.15 | 60.10 | 28 | 1834 | 2142 | 2354081 |
| Generalised tonic-clonic seizure | 100.95 | 60.10 | 33 | 1829 | 5339 | 2350884 |
| Maternal exposure during pregnancy | 96.83 | 60.10 | 42 | 1820 | 14821 | 2341402 |
| Delirium | 93.77 | 60.10 | 31 | 1831 | 5192 | 2351031 |
| Serotonin syndrome | 88.31 | 60.10 | 27 | 1835 | 3513 | 2352710 |
| Labile blood pressure | 87.94 | 60.10 | 16 | 1846 | 207 | 2356016 |
| Propofol infusion syndrome | 84.46 | 60.10 | 14 | 1848 | 100 | 2356123 |
| Anaesthetic complication neurological | 84.36 | 60.10 | 12 | 1850 | 24 | 2356199 |
| Bronchospasm | 83.74 | 60.10 | 25 | 1837 | 2999 | 2353224 |
| Respiratory acidosis | 83.01 | 60.10 | 19 | 1843 | 802 | 2355421 |
| Completed suicide | 82.90 | 60.10 | 42 | 1820 | 20992 | 2335231 |
| Shock | 80.91 | 60.10 | 26 | 1836 | 3978 | 2352245 |
| Cardiogenic shock | 79.54 | 60.10 | 23 | 1839 | 2468 | 2353755 |
| Loss of consciousness | 78.42 | 60.10 | 39 | 1823 | 18728 | 2337495 |
| Apnoea | 77.64 | 60.10 | 20 | 1842 | 1391 | 2354832 |
| Sedation | 76.91 | 60.10 | 24 | 1838 | 3338 | 2352885 |
| Anaesthetic complication | 76.56 | 60.10 | 16 | 1846 | 439 | 2355784 |
| Mitochondrial DNULL mutation | 75.98 | 60.10 | 10 | 1852 | 7 | 2356216 |
| Myoclonus | 75.18 | 60.10 | 22 | 1840 | 2461 | 2353762 |
| Upper airway obstruction | 73.98 | 60.10 | 13 | 1849 | 136 | 2356087 |
| Drug abuse | 71.84 | 60.10 | 32 | 1830 | 11994 | 2344229 |
| Foetal death | 71.62 | 60.10 | 20 | 1842 | 1892 | 2354331 |
| Diabetic macroangiopathy | 71.34 | 60.10 | 9 | 1853 | 2 | 2356221 |
| Delayed recovery from anaesthesia | 70.69 | 60.10 | 13 | 1849 | 179 | 2356044 |
| Cardio-respiratory arrest | 69.98 | 60.10 | 29 | 1833 | 9117 | 2347106 |
| Intra-abdominal pressure increased | 69.97 | 60.10 | 10 | 1852 | 21 | 2356202 |
| Respiratory arrest | 69.87 | 60.10 | 26 | 1836 | 6152 | 2350071 |
| Sinus tachycardia | 68.85 | 60.10 | 22 | 1840 | 3303 | 2352920 |
| Electrocardiogram ST segment depression | 67.13 | 60.10 | 15 | 1847 | 567 | 2355656 |
| Procedural complication | 66.91 | 60.10 | 17 | 1845 | 1118 | 2355105 |
| Foetal growth restriction | 66.84 | 60.10 | 17 | 1845 | 1123 | 2355100 |
| Pneumatosis | 66.67 | 60.10 | 11 | 1851 | 76 | 2356147 |
| Blood pressure decreased | 66.35 | 60.10 | 28 | 1834 | 9208 | 2347015 |
| Encephalopathy | 65.85 | 60.10 | 23 | 1839 | 4538 | 2351685 |
| Somnolence | 64.75 | 60.10 | 37 | 1825 | 23448 | 2332775 |
| Anaesthetic complication pulmonary | 63.96 | 60.10 | 9 | 1853 | 16 | 2356207 |
| Unwanted awareness during anaesthesia | 63.71 | 60.10 | 10 | 1852 | 48 | 2356175 |
| Systemic inflammatory response syndrome | 62.74 | 60.10 | 15 | 1847 | 766 | 2355457 |
| Diabetes insipidus | 61.91 | 60.10 | 13 | 1849 | 365 | 2355858 |
| Blood lactic acid increased | 61.46 | 60.10 | 15 | 1847 | 836 | 2355387 |
| Kounis syndrome | 60.57 | 60.10 | 12 | 1850 | 250 | 2355973 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Hypotension | 456.06 | 51.49 | 177 | 1687 | 29477 | 1715440 |
| Drug ineffective | 383.80 | 51.49 | 197 | 1667 | 63604 | 1681313 |
| Anaphylactic reaction | 283.03 | 51.49 | 84 | 1780 | 6029 | 1738888 |
| Toxicity to various agents | 261.16 | 51.49 | 119 | 1745 | 29022 | 1715895 |
| Sedation | 249.01 | 51.49 | 67 | 1797 | 3350 | 1741567 |
| Respiratory depression | 221.29 | 51.49 | 56 | 1808 | 2191 | 1742726 |
| Oxygen saturation decreased | 198.67 | 51.49 | 63 | 1801 | 5612 | 1739305 |
| Cardiac arrest | 180.64 | 51.49 | 77 | 1787 | 15853 | 1729064 |
| Coma | 171.76 | 51.49 | 60 | 1804 | 7202 | 1737715 |
| Status epilepticus | 167.29 | 51.49 | 44 | 1820 | 2002 | 1742915 |
| Tachycardia | 166.46 | 51.49 | 68 | 1796 | 12560 | 1732357 |
| Seizure | 165.31 | 51.49 | 78 | 1786 | 20363 | 1724554 |
| Bradycardia | 164.09 | 51.49 | 64 | 1800 | 10470 | 1734447 |
| Respiratory arrest | 156.51 | 51.49 | 53 | 1811 | 5786 | 1739131 |
| Drug abuse | 138.08 | 51.49 | 61 | 1803 | 13628 | 1731289 |
| Agitation | 130.39 | 51.49 | 55 | 1809 | 10971 | 1733946 |
| Hyperthermia malignant | 126.33 | 51.49 | 25 | 1839 | 304 | 1744613 |
| Respiratory failure | 122.10 | 51.49 | 57 | 1807 | 14448 | 1730469 |
| Delirium | 118.13 | 51.49 | 44 | 1820 | 6318 | 1738599 |
| Cardio-respiratory arrest | 115.32 | 51.49 | 48 | 1816 | 9245 | 1735672 |
| Unresponsive to stimuli | 108.33 | 51.49 | 38 | 1826 | 4591 | 1740326 |
| Anaesthetic complication neurological | 100.45 | 51.49 | 15 | 1849 | 23 | 1744894 |
| Anaphylactic shock | 96.35 | 51.49 | 31 | 1833 | 2868 | 1742049 |
| Pulseless electrical activity | 93.26 | 51.49 | 24 | 1840 | 996 | 1743921 |
| Dyskinesia | 91.81 | 51.49 | 32 | 1832 | 3787 | 1741130 |
| Metabolic acidosis | 91.66 | 51.49 | 35 | 1829 | 5367 | 1739550 |
| Drug reaction with eosinophilia and systemic symptoms | 90.18 | 51.49 | 34 | 1830 | 5036 | 1739881 |
| Blood pressure decreased | 89.79 | 51.49 | 38 | 1826 | 7608 | 1737309 |
| Procedural complication | 86.35 | 51.49 | 23 | 1841 | 1093 | 1743824 |
| Rhabdomyolysis | 85.28 | 51.49 | 41 | 1823 | 11049 | 1733868 |
| Depressed level of consciousness | 84.91 | 51.49 | 35 | 1829 | 6557 | 1738360 |
| Circulatory collapse | 83.13 | 51.49 | 29 | 1835 | 3438 | 1741479 |
| Somnolence | 82.85 | 51.49 | 46 | 1818 | 16693 | 1728224 |
| Hyperthermia | 81.25 | 51.49 | 24 | 1840 | 1667 | 1743250 |
| Acidosis hyperchloraemic | 78.83 | 51.49 | 13 | 1851 | 49 | 1744868 |
| Hypoxia | 74.54 | 51.49 | 31 | 1833 | 5932 | 1738985 |
| Apnoea | 71.51 | 51.49 | 21 | 1843 | 1428 | 1743489 |
| Confusional state | 70.11 | 51.49 | 45 | 1819 | 21233 | 1723684 |
| Diabetes insipidus | 64.40 | 51.49 | 15 | 1849 | 407 | 1744510 |
| Intestinal ischaemia | 64.22 | 51.49 | 18 | 1846 | 1035 | 1743882 |
| Neonatal respiratory depression | 62.77 | 51.49 | 11 | 1853 | 64 | 1744853 |
| Mental status changes | 60.82 | 51.49 | 27 | 1837 | 6048 | 1738869 |
| Product administered to patient of inappropriate age | 59.17 | 51.49 | 16 | 1848 | 804 | 1744113 |
| Post procedural complication | 57.38 | 51.49 | 20 | 1844 | 2360 | 1742557 |
| Drug interaction | 56.80 | 51.49 | 44 | 1820 | 27914 | 1717003 |
| Aggression | 56.31 | 51.49 | 28 | 1836 | 8087 | 1736830 |
| Rash maculo-papular | 55.69 | 51.49 | 22 | 1842 | 3681 | 1741236 |
| Hypoventilation | 55.53 | 51.49 | 14 | 1850 | 533 | 1744384 |
| Ventricular fibrillation | 54.51 | 51.49 | 20 | 1844 | 2736 | 1742181 |
| Overdose | 54.16 | 51.49 | 35 | 1829 | 16666 | 1728251 |
| Respiratory distress | 51.86 | 51.49 | 23 | 1841 | 5134 | 1739783 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05CD08 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine derivatives |
| MeSH PA | D000759 | Adjuvants, Anesthesia |
| FDA EPC | N0000175694 | Benzodiazepine |
| FDA CS | M0002356 | Benzodiazepines |
| MeSH PA | D000777 | Anesthetics |
| MeSH PA | D018686 | Anesthetics, Intravenous |
| CHEBI has role | CHEBI:91016 | GABAA receptor agonist |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:35474 | anxiolytic drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:51371 | muscle relaxant |
| CHEBI has role | CHEBI:35717 | sedative |
| CHEBI has role | CHEBI:38869 | general anaesthetic |
| CHEBI has role | CHEBI:35488 | central nervous system depressant |
| MeSH PA | D014151 | Anti-Anxiety Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D018682 | GABA Agents |
| MeSH PA | D018757 | GABA Modulators |
| MeSH PA | D006993 | Hypnotics and Sedatives |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D014149 | Tranquilizing Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Feeling agitated | indication | 24199005 | |
| Anxiety | indication | 48694002 | |
| General anesthesia | indication | 50697003 | |
| Sedation | indication | 72641008 | |
| Conscious sedation | indication | 314271007 | |
| Local anesthesia | indication | 386761002 | |
| Induce Anterograde Amnesia | indication | ||
| Sedation in Intubated Patients | indication | ||
| Preoperative Anxiety | indication | ||
| Sedation as Adjunct to Anesthesia | indication | ||
| Insomnia | off-label use | 193462001 | |
| Status epilepticus | off-label use | 230456007 | DOID:1824 |
| Cocaine-Associated Acute Ischemic Heart Disease | off-label use | ||
| Chronic obstructive lung disease | contraindication | 13645005 | DOID:3083 |
| Cirrhosis of liver | contraindication | 19943007 | DOID:5082 |
| Shock | contraindication | 27942005 | |
| End stage renal disease | contraindication | 46177005 | DOID:784 |
| Chronic heart failure | contraindication | 48447003 | |
| Pregnancy, function | contraindication | 289908002 | |
| Coma | contraindication | 371632003 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Hemodynamic instability | contraindication | 422773005 | |
| Peripheral Vasoconstriction | contraindication |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 6.07 | Basic |
| pKa2 | 2.36 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | 8217033 | Jan. 18, 2028 | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | 9289432 | Jan. 18, 2028 | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | 9687495 | Jan. 18, 2028 | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | May 21, 2022 | NEW PRODUCT |
| EQ 50MG BASE/10ML (EQ 5MG BASE/ML) | SEIZALAM | MERIDIAN MEDCL TECHN | N209566 | Sept. 14, 2018 | RX | SOLUTION | INTRAMUSCULAR | Sept. 14, 2025 | TREATMENT OF STATUS EPILEPTICUS IN ADULTS |
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | May 17, 2026 | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor alpha-1/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.74 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-3/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.44 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-5/beta-3/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.26 | WOMBAT-PK | CHEMBL | |||
| GABA-A receptor alpha-5/beta-3/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 9.12 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-3/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 7.61 | WOMBAT-PK | CHEMBL | |||
| GABA-A receptor alpha-1/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 7.75 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-5/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 9.12 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-5/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.26 | WOMBAT-PK | CHEMBL | |||
| Multidrug resistance protein 1 | Transporter | Km | 4.35 | WOMBAT-PK | |||||
| Cytochrome P450 3A4 | Enzyme | Km | 6 | WOMBAT-PK | |||||
| Thyrotropin-releasing hormone receptor | GPCR | ANTAGONIST | Ki | 5.49 | IUPHAR | ||||
| GABA-A receptor; anion channel | Ion channel | Ki | 8.70 | CHEMBL | |||||
| Translocator protein | Membrane receptor | Ki | 8.70 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019839 | VUID |
| N0000147927 | NUI |
| C0026056 | UMLSCUI |
| D00550 | KEGG_DRUG |
| 26800000 | SNOMEDCT_US |
| 4019839 | VANDF |
| 6960 | RXNORM |
| 373476007 | SNOMEDCT_US |
| d00301 | MMSL |
| 130935 | MMSL |
| 24970 | MMSL |
| 004585 | NDDF |
| CHEMBL655 | ChEMBL_ID |
| DB00683 | DRUGBANK_ID |
| CHEMBL1200420 | ChEMBL_ID |
| R60L0SM5BC | UNII |
| 4497 | INN_ID |
| 08J | PDB_CHEM_ID |
| CHEBI:6931 | CHEBI |
| 59467-96-8 | SECONDARY_CAS_RN |
| 4192 | PUBCHEM_CID |
| D008874 | MESH_DESCRIPTOR_UI |
| 3342 | IUPHAR_LIGAND_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-3566 | SYRUP | 2 mg | ORAL | ANDA | 14 sections |
| MIDAZOLAM HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2305 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2306 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2307 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | ANDA | 15 sections |
| MIDAZOLAM HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2308 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2587 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2596 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0574-0150 | SYRUP | 2 mg | ORAL | ANDA | 15 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6056 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6057 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6059 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6060 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6061 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6063 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6190 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 15 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6209 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6210 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6211 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Seizalam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 11704-650 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | NDA | 18 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-523 | INJECTION | 1 mg | INTRAVENOUS | ANDA | 15 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-524 | INJECTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0146 | SYRUP | 2 mg | ORAL | ANDA | 15 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0205 | SYRUP | 2 mg | ORAL | ANDA | 12 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-3566 | SYRUP | 2 mg | ORAL | ANDA | 13 sections |
| Midazolam hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-600 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 14 sections |
| Midazolam hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-601 | INJECTION, SOLUTION | 5 mg | INTRAVENOUS | ANDA | 14 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-588 | INJECTION, SOLUTION | 2 mg | INTRAVENOUS | ANDA | 15 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-589 | INJECTION, SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-0683 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 16 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-0738 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 16 sections |