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

Stem definition	Drug id	CAS RN
	725	76-57-3

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.10	g	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
Jan. 21, 1952	FDA	ANI PHARMS

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 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 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 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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	8.38	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
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	6.14	CHEMBL	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	AGONIST	Ki	4.59	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	AGONIST	Ki	4.28	CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRK_RAT OPRM_RAT SGMR1_RAT		IC50	8	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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