codeine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
725 76-57-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • codeine phosphate anhydrous
  • codeine anhydrous
  • codeine monohydrate
  • codeine
  • (-)-Codeine
  • morphine monomethyl ether
  • methylmorphine
  • codeine phosphate
  • codeine sulfate
  • codeine phosphate hydrate
  • codeine polistirex
  • N-Methylmorphine
An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.
  • Molecular weight: 299.37
  • Formula: C18H21NO3
  • CLOGP: 0.98
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 41.93
  • ALOGS: -2.72
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 435 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.04 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 15 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 1952 FDA ANI PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 13717.86 33.69 2949 2427 43694 2309015
Toxicity to various agents 1878.88 33.69 599 4777 32155 2320554
Completed suicide 855.38 33.69 299 5077 20735 2331974
Drug abuse 715.22 33.69 228 5148 11798 2340911
Rheumatoid arthritis 437.16 33.69 179 5197 18961 2333748
Rash 427.01 33.69 252 5124 59306 2293403
Granuloma skin 388.57 33.69 61 5315 62 2352647
Blood parathyroid hormone decreased 366.18 33.69 63 5313 159 2352550
Overdose 344.37 33.69 153 5223 19754 2332955
Drug ineffective 343.62 33.69 270 5106 101354 2251355
Drug intolerance 342.79 33.69 137 5239 13580 2339129
Panniculitis 310.87 33.69 63 5313 472 2352237
Vomiting 291.64 33.69 213 5163 71389 2281320
Nausea 291.35 33.69 256 5120 111933 2240776
Rheumatoid nodule 290.25 33.69 61 5315 557 2352152
Pain 283.95 33.69 198 5178 61659 2291050
Hypercalcaemia 247.47 33.69 71 5305 2521 2350188
Skin necrosis 243.27 33.69 59 5317 1072 2351637
Contraindicated product administered 241.06 33.69 72 5304 2949 2349760
Urticaria 230.69 33.69 124 5252 24137 2328572
Peripheral swelling 228.47 33.69 111 5265 17486 2335223
Drug eruption 218.73 33.69 68 5308 3191 2349518
Basal cell carcinoma 214.19 33.69 64 5312 2623 2350086
Substance abuse 205.72 33.69 45 5331 504 2352205
Loss of personal independence in daily activities 201.15 33.69 72 5304 5239 2347470
Infusion related reaction 200.73 33.69 85 5291 9711 2342998
Anaphylactic reaction 194.84 33.69 83 5293 9622 2343087
Skin ulcer 192.15 33.69 65 5311 3994 2348715
Hypersensitivity 186.94 33.69 107 5269 23486 2329223
Aspartate aminotransferase increased 186.31 33.69 87 5289 12525 2340184
Treatment failure 179.45 33.69 72 5304 7167 2345542
Ulcer 177.18 33.69 51 5325 1829 2350880
Somnolence 176.71 33.69 103 5273 23382 2329327
Contrast media allergy 174.23 33.69 34 5342 204 2352505
Malaise 170.22 33.69 140 5236 55445 2297264
Alanine aminotransferase increased 168.53 33.69 84 5292 13948 2338761
Rash pruritic 166.44 33.69 69 5307 7466 2345243
Inflammation 158.15 33.69 63 5313 6150 2346559
C-reactive protein increased 157.74 33.69 63 5313 6192 2346517
Intentional overdose 157.64 33.69 75 5301 11246 2341463
Drug dependence 156.94 33.69 52 5324 2993 2349716
Coma 151.03 33.69 68 5308 8988 2343721
Pruritus 134.25 33.69 110 5266 43230 2309479
Blood pressure systolic increased 128.79 33.69 42 5334 2297 2350412
Cardio-respiratory arrest 128.54 33.69 61 5315 9085 2343624
Arthralgia 122.38 33.69 115 5261 54170 2298539
Drug tolerance decreased 122.05 33.69 26 5350 254 2352455
Death 121.23 33.69 138 5238 81330 2271379
Tenosynovitis 116.47 33.69 28 5348 488 2352221
Respiratory depression 115.58 33.69 38 5338 2132 2350577
Respiratory arrest 111.33 33.69 49 5327 6129 2346580
Joint swelling 108.79 33.69 67 5309 16752 2335957
Dyspnoea 108.09 33.69 128 5248 78605 2274104
Constipation 105.11 33.69 72 5304 21557 2331152
Herpes zoster 104.36 33.69 54 5322 9671 2343038
Intentional product misuse 102.72 33.69 53 5323 9436 2343273
Asphyxia 102.49 33.69 29 5347 975 2351734
Serotonin syndrome 100.96 33.69 39 5337 3501 2349208
Accidental overdose 100.06 33.69 40 5336 3932 2348777
Abdominal discomfort 96.56 33.69 63 5313 17393 2335316
Poisoning deliberate 93.26 33.69 28 5348 1163 2351546
Gait disturbance 93.20 33.69 68 5308 22477 2330232
Red blood cell sedimentation rate increased 92.40 33.69 32 5344 2105 2350604
Red blood cell sedimentation rate abnormal 90.85 33.69 23 5353 500 2352209
Body temperature decreased 90.35 33.69 28 5348 1295 2351414
Drug interaction 90.10 33.69 74 5302 29089 2323620
Wrist surgery 89.20 33.69 18 5358 131 2352578
Headache 87.06 33.69 116 5260 80063 2272646
Dizziness 84.73 33.69 98 5278 58567 2294142
Hepatic steatosis 83.16 33.69 33 5343 3180 2349529
Toxicologic test abnormal 83.05 33.69 17 5359 134 2352575
Pancreatic fibrosis 82.95 33.69 12 5364 2 2352707
Upper respiratory tract infection 80.42 33.69 44 5332 8807 2343902
Poisoning 80.16 33.69 31 5345 2789 2349920
Renal papillary necrosis 80.05 33.69 14 5362 40 2352669
Cough 79.96 33.69 73 5303 33044 2319665
Abdominal pain upper 78.75 33.69 61 5315 22039 2330670
Therapeutic product effect decreased 77.50 33.69 46 5330 10743 2341966
Abdominal pain 75.71 33.69 72 5304 34302 2318407
Miosis 75.63 33.69 24 5352 1200 2351509
Hallucination 75.39 33.69 41 5335 8107 2344602
Arthropathy 73.83 33.69 39 5337 7277 2345432
Cardiac arrest 73.18 33.69 50 5326 14880 2337829
Arteriosclerosis coronary artery 72.48 33.69 23 5353 1150 2351559
C-reactive protein abnormal 72.24 33.69 21 5355 778 2351931
Musculoskeletal stiffness 72.12 33.69 46 5330 12201 2340508
Hypertension 69.33 33.69 62 5314 27299 2325410
Obliterative bronchiolitis 69.22 33.69 16 5360 233 2352476
Psoriasis 67.31 33.69 50 5326 16958 2335751
Visceral congestion 66.54 33.69 12 5364 43 2352666
Distributive shock 66.17 33.69 13 5363 81 2352628
Hypotension 65.88 33.69 65 5311 32371 2320338
Limb operation 65.40 33.69 18 5358 545 2352164
Pyrexia 64.87 33.69 82 5294 53626 2299083
Tachycardia 64.40 33.69 48 5328 16361 2336348
Depressed level of consciousness 64.13 33.69 36 5340 7568 2345141
Confusional state 63.33 33.69 56 5320 24288 2328421
Delirium 61.81 33.69 31 5345 5192 2347517
Aggression 61.36 33.69 30 5346 4756 2347953
Restless legs syndrome 61.13 33.69 24 5352 2247 2350462
Fall 60.21 33.69 74 5302 47025 2305684
Red blood cell sedimentation rate 59.68 33.69 10 5366 20 2352689
Finger deformity 58.25 33.69 18 5358 824 2351885
Swelling 57.92 33.69 45 5331 16305 2336404
Metabolic acidosis 57.76 33.69 31 5345 5967 2346742
Insomnia 56.71 33.69 54 5322 25733 2326976
Myocardial fibrosis 56.34 33.69 12 5364 117 2352592
Gallbladder cholesterolosis 54.45 33.69 12 5364 139 2352570
Hyperhidrosis 53.66 33.69 42 5334 15380 2337329
Acute kidney injury 52.75 33.69 54 5322 28068 2324641
Loss of consciousness 52.47 33.69 45 5331 18722 2333987
Musculoskeletal pain 52.41 33.69 36 5340 10794 2341915
Patient uncooperative 51.64 33.69 9 5367 25 2352684
Pneumonia 51.33 33.69 70 5306 49226 2303483
Bradypnoea 50.99 33.69 14 5362 420 2352289
Condition aggravated 50.43 33.69 56 5320 31923 2320786
Fatigue 50.22 33.69 93 5283 84780 2267929
Enthesopathy 47.86 33.69 11 5365 156 2352553
Stubbornness 47.42 33.69 8 5368 17 2352692
Needle issue 47.31 33.69 16 5360 978 2351731
Agitation 47.12 33.69 34 5342 11017 2341692
Syncope 46.23 33.69 40 5336 16835 2335874
Deformity 44.65 33.69 13 5363 484 2352225
Acute hepatic failure 44.49 33.69 20 5356 2622 2350087
White blood cell count abnormal 44.09 33.69 14 5362 701 2352008
Cerebral thrombosis 43.14 33.69 12 5364 378 2352331
Neck pain 43.04 33.69 28 5348 7669 2345040
Erythema 43.04 33.69 46 5330 25113 2327596
Sleep disorder 42.27 33.69 26 5350 6463 2346246
Postmortem blood drug level abnormal 42.12 33.69 7 5369 13 2352696
Blood pressure diastolic decreased 41.98 33.69 15 5361 1080 2351629
Synovitis 40.77 33.69 19 5357 2707 2350002
Skin depigmentation 38.56 33.69 9 5367 137 2352572
Abdominal hernia 38.02 33.69 12 5364 589 2352120
Back pain 37.61 33.69 48 5328 31611 2321098
Brain oedema 37.36 33.69 17 5359 2293 2350416
Sacroiliitis 37.28 33.69 10 5366 274 2352435
Hepatic enzyme increased 36.93 33.69 28 5348 9774 2342935
Diarrhoea 36.76 33.69 81 5295 83483 2269226
Drug withdrawal syndrome 36.16 33.69 24 5352 6797 2345912
Thirst 35.63 33.69 15 5361 1679 2351030
Sciatica 35.51 33.69 16 5360 2109 2350600
Blood pressure systolic decreased 35.33 33.69 12 5364 743 2351966
Visual impairment 34.50 33.69 29 5347 11726 2340983
Blood pressure increased 34.36 33.69 34 5342 16952 2335757
Cogwheel rigidity 33.93 33.69 9 5367 236 2352473
H1N1 influenza 33.72 33.69 9 5367 242 2352467

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 3329.05 52.65 750 2106 12939 1730986
Toxicity to various agents 2789.75 52.65 755 2101 28386 1715539
Drug hypersensitivity 1299.13 52.65 366 2490 14769 1729156
Completed suicide 531.67 52.65 190 2666 16122 1727803
Overdose 531.08 52.65 191 2665 16510 1727415
Intentional product misuse 479.52 52.65 145 2711 7213 1736712
Substance abuse 368.99 52.65 79 2777 924 1743001
Death 336.66 52.65 237 2619 87206 1656719
Poisoning 301.01 52.65 80 2776 2452 1741473
Drug dependence 213.50 52.65 65 2791 3262 1740663
Cardio-respiratory arrest 212.77 52.65 84 2772 9209 1734716
Respiratory arrest 192.61 52.65 69 2787 5770 1738155
Depressed level of consciousness 166.34 52.65 64 2792 6528 1737397
Intentional overdose 136.65 52.65 58 2798 7612 1736313
Cardiac arrest 131.66 52.65 71 2785 15859 1728066
Pulmonary oedema 114.61 52.65 49 2807 6537 1737388
Accidental overdose 106.96 52.65 41 2815 4123 1739802
Drug interaction 92.74 52.65 70 2786 27888 1716037
Asphyxia 90.51 52.65 26 2830 1057 1742868
Constipation 89.25 52.65 54 2802 14946 1728979
Respiratory depression 83.26 52.65 29 2827 2218 1741707
Unresponsive to stimuli 82.33 52.65 35 2821 4594 1739331
Pulmonary congestion 81.41 52.65 27 2829 1778 1742147
Pneumonia aspiration 81.19 52.65 36 2820 5230 1738695
Vomiting 79.27 52.65 73 2783 38242 1705683
Serotonin syndrome 66.39 52.65 26 2830 2762 1741163
Somnolence 62.32 52.65 45 2811 16694 1727231
Miosis 54.44 52.65 19 2837 1459 1742466

Pharmacologic Action:

SourceCodeDescription
ATC R05DA04 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
ATC N02AA59 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA79 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ07 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ09 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:60606 opioid receptor agonist
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:88188 drug allergen
MeSH PA D000996 Antitussive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Headache disorder indication 230461009
Sore throat symptom indication 267102003
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Muscle Spasm with Pain indication
Diarrhea off-label use 62315008
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Constipation contraindication 14760008 DOID:2089
Hyperbilirubinemia contraindication 14783006 DOID:2741
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Disorder of the central nervous system contraindication 23853001 DOID:331
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Sedation contraindication 72641008
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Decreased respiratory function contraindication 80954004
Disorder of brain contraindication 81308009 DOID:936
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Acute intermittent porphyria contraindication 234422006 DOID:3890
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Poor metabolizer due to cytochrome p450 CYP2C19 variant contraindication 424500005
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Acute exacerbation of asthma contraindication 708038006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
54.3MG TUXARIN ER MAINPOINTE N206323 June 22, 2015 RX TABLET, EXTENDED RELEASE ORAL 9066942 Jan. 3, 2032 TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 6.14 CHEMBL CHEMBL
Kappa-type opioid receptor GPCR AGONIST Ki 4.59 CHEMBL
Delta-type opioid receptor GPCR AGONIST Ki 4.28 CHEMBL
Opioid receptor GPCR IC50 8 CHEMBL

External reference:

IDSource
D003061 MESH_DESCRIPTOR_UI
4017509 VUID
N0000145894 NUI
C0009214 UMLSCUI
D00195 KEGG_DRUG
11QV9BS0CB UNII
6854-40-6 SECONDARY_CAS_RN
85990009 SNOMEDCT_US
4017509 VANDF
001550 NDDF
2670 RXNORM
387494007 SNOMEDCT_US
4490 MMSL
d00012 MMSL
CHEBI:16714 CHEBI
CHEMBL485 ChEMBL_ID
CHEMBL284671 ChEMBL_ID
CHEMBL369475 ChEMBL_ID
DB00318 DRUGBANK_ID
CHEMBL1159819 ChEMBL_ID
1673 IUPHAR_LIGAND_ID
5284371 PUBCHEM_CID
CHEMBL1201099 ChEMBL_ID
CHEMBL1201463 ChEMBL_ID
CHEMBL4297091 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fiorinal with Codeine HUMAN PRESCRIPTION DRUG LABEL 4 0023-6010 CAPSULE 30 mg ORAL NDA 20 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0243 TABLET 15 mg ORAL NDA 19 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0244 TABLET 30 mg ORAL NDA 19 sections
Codeine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0245 TABLET 60 mg ORAL NDA 19 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0050 TABLET 15 mg ORAL ANDA 14 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0150 TABLET 30 mg ORAL ANDA 14 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0093-0350 TABLET 60 mg ORAL ANDA 14 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-0504 SOLUTION 12 mg ORAL ANDA 15 sections
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0121-0547 SYRUP 10 mg ORAL ANDA 15 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-0775 SOLUTION 10 mg ORAL OTC monograph final 9 sections
Acetaminophen and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 2 0121-1008 SOLUTION 30 mg ORAL ANDA 15 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1550 SOLUTION 10 mg ORAL OTC monograph final 9 sections
Guaifenesin and Codeine Phosphate HUMAN OTC DRUG LABEL 2 0121-1775 SOLUTION 10 mg ORAL OTC monograph final 9 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0483 TABLET 15 mg ORAL ANDA 14 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0484 TABLET 30 mg ORAL ANDA 14 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0406-0485 TABLET 60 mg ORAL ANDA 14 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7026 TABLET 30 mg ORAL ANDA 15 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0440-7027 TABLET 60 mg ORAL ANDA 15 sections
Butalbital, Aspirin, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0527-1312 CAPSULE 30 mg ORAL ANDA 12 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1698 TABLET 30 mg ORAL ANDA 19 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1699 TABLET 60 mg ORAL ANDA 19 sections
Codeine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1727 TABLET 15 mg ORAL ANDA 19 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0591-2641 CAPSULE 30 mg ORAL ANDA 19 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0591-3220 CAPSULE 30 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Butalbital, Aspirin, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0591-3546 CAPSULE 30 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Promethazine with Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0603-1585 SOLUTION 10 mg ORAL ANDA 18 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0603-2337 TABLET 15 mg ORAL ANDA 15 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0603-2338 TABLET 30 mg ORAL ANDA 15 sections
Acetaminophen And Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0603-2339 TABLET 60 mg ORAL ANDA 15 sections
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0603-2553 CAPSULE 30 mg ORAL ANDA 20 sections