carbidopa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
dopamine receptor agonists, dopamine derivatives, used as antiparkinsonism/prolactin inhibitors	496	28860-95-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: carbidopa hydrate carbidopa lodosin (S)-Carbidopa lodosyn alpha-Methyldopahydrazine	An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself. Molecular weight: 226.23 Formula: C10H14N2O4 CLOGP: -0.44 LIPINSKI: 0 HAC: 6 HDO: 5 TPSA: 115.81 ALOGS: -1.78 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

carbidopa hydrate
carbidopa
lodosin
(S)-Carbidopa
lodosyn
alpha-Methyldopahydrazine

An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself.

Molecular weight: 226.23
Formula: C10H14N2O4
CLOGP: -0.44
LIPINSKI: 0
HAC: 6
HDO: 5
TPSA: 115.81
ALOGS: -1.78
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	2.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5.30 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	3.68 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
Oct. 17, 2010	EMA	Orion Corporation
May 2, 1975	FDA	MERCK SHARP DOHME

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
Hallucination	183.59	17.24	101	7394	54716	63426811
Parkinson's disease	174.14	17.24	38	7457	1181	63480346
Dyskinesia	153.24	17.24	75	7420	31927	63449600
Tremor	98.09	17.24	98	7397	132141	63349386
Hallucination, visual	94.65	17.24	46	7449	19252	63462275
Fall	66.30	17.24	144	7351	392190	63089337
Confusional state	65.14	17.24	107	7388	236273	63245254
Product complaint	55.28	17.24	28	7467	12781	63468746
Gambling disorder	54.46	17.24	15	7480	1237	63480290
Drug interaction	49.19	17.24	93	7402	229038	63252489
Compulsive shopping	46.87	17.24	12	7483	747	63480780
Impulse-control disorder	46.39	17.24	12	7483	778	63480749
Parkinsonism	45.58	17.24	23	7472	10416	63471111
Agitation	43.69	17.24	44	7451	59713	63421814
Muscle rigidity	43.47	17.24	23	7472	11477	63470050
Delusion	42.52	17.24	23	7472	11994	63469533
Delirium	42.15	17.24	40	7455	50501	63431026
Abnormal behaviour	41.89	17.24	28	7467	21398	63460129
Ileus	40.78	17.24	24	7471	14701	63466826
Sudden onset of sleep	35.41	17.24	9	7486	544	63480983
Aortic valve incompetence	34.63	17.24	16	7479	5972	63475555
Neuroleptic malignant syndrome	34.30	17.24	20	7475	12036	63469491
Wrong product administered	34.25	17.24	16	7479	6125	63475402
Orthostatic hypotension	32.81	17.24	30	7465	36130	63445397
Dementia	30.72	17.24	22	7473	18772	63462755
Purpura senile	30.40	17.24	8	7487	555	63480972
Depressed level of consciousness	30.30	17.24	37	7458	62041	63419486
Tarsal tunnel syndrome	30.24	17.24	8	7487	566	63480961
Off label use	29.55	17.24	22	7473	674440	62807087
Psychotic disorder	28.69	17.24	24	7471	25688	63455839
Speech disorder	28.02	17.24	29	7466	40600	63440927
Resorption bone increased	27.98	17.24	9	7486	1265	63480262
Vascular encephalopathy	27.36	17.24	7	7488	434	63481093
Gait disturbance	27.19	17.24	64	7431	183114	63298413
Aggression	26.36	17.24	22	7473	23476	63458051
Hypersexuality	26.19	17.24	7	7488	515	63481012
Movement disorder	25.80	17.24	21	7474	21640	63459887
Disorientation	25.14	17.24	27	7468	39425	63442102
Somnolence	24.98	17.24	61	7434	178624	63302903
Alopecia	24.55	17.24	5	7490	337531	63143996
Dysphagia	24.18	17.24	40	7455	88545	63392982
Psychomotor hyperactivity	23.44	17.24	15	7480	10648	63470879
Blood creatine phosphokinase increased	23.32	17.24	23	7472	30407	63451120
Vestibular disorder	23.04	17.24	8	7487	1423	63480104
Coronary artery dissection	22.72	17.24	7	7488	855	63480672
Stereotypy	22.52	17.24	6	7489	436	63481091
Joint swelling	21.57	17.24	6	7489	327660	63153867
On and off phenomenon	21.09	17.24	8	7487	1827	63479700
Renal failure	20.69	17.24	44	7451	117608	63363919
Freezing phenomenon	20.05	17.24	7	7488	1265	63480262
Application site reaction	19.39	17.24	6	7489	744	63480783
Tongue necrosis	19.31	17.24	3	7492	12	63481515
Peripheral swelling	19.20	17.24	4	7491	265938	63215589
Product administration error	19.19	17.24	18	7477	22379	63459148
Medication error	19.05	17.24	27	7468	52257	63429270
Bradykinesia	18.55	17.24	10	7485	5178	63476349
Akinesia	18.51	17.24	7	7488	1586	63479941
Anxiety	18.42	17.24	62	7433	217479	63264048
Nasopharyngitis	18.00	17.24	4	7491	254253	63227274
Rheumatoid arthritis	17.95	17.24	4	7491	253815	63227712
Kleptomania	17.33	17.24	3	7492	26	63481501

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
Parkinson's disease	226.69	16.81	55	8076	1369	34947431
Hallucination	207.35	16.81	136	7995	51362	34897438
Gambling disorder	193.72	16.81	50	8081	1610	34947190
Hypersexuality	174.36	16.81	45	8086	1448	34947352
Hallucination, visual	135.23	16.81	71	8060	17720	34931080
Muscle rigidity	128.25	16.81	58	8073	10460	34938340
Dyskinesia	125.16	16.81	73	8058	22340	34926460
Fall	101.24	16.81	174	7957	202711	34746089
On and off phenomenon	92.94	16.81	31	8100	2466	34946334
Confusional state	80.26	16.81	130	8001	144030	34804770
Sudden onset of sleep	66.47	16.81	16	8115	384	34948416
Orthostatic hypotension	66.20	16.81	52	8079	25867	34922933
Delusion	64.85	16.81	39	8092	12596	34936204
Neuroleptic malignant syndrome	63.93	16.81	44	8087	17890	34930910
Agitation	62.89	16.81	72	8059	57327	34891473
Gambling	59.90	16.81	13	8118	193	34948607
Abnormal behaviour	59.29	16.81	48	8083	24921	34923879
Impulse-control disorder	55.86	16.81	18	8113	1283	34947517
Dopamine dysregulation syndrome	54.48	16.81	14	8117	442	34948358
Somnolence	50.92	16.81	92	8039	111024	34837776
Tremor	50.72	16.81	78	8053	82509	34866291
Psychotic disorder	49.76	16.81	43	8088	24409	34924391
Aggression	48.02	16.81	52	8079	38912	34909888
Bradykinesia	45.95	16.81	21	8110	3872	34944928
Dysphagia	42.69	16.81	62	8069	62319	34886481
Off label use	41.69	16.81	23	8108	419501	34529299
Dementia	40.40	16.81	30	8101	13718	34935082
Parkinsonism	36.36	16.81	23	8108	8115	34940685
Delirium	33.45	16.81	46	8085	43945	34904855
Obsessive-compulsive disorder	33.36	16.81	19	8112	5545	34943255
Product complaint	32.35	16.81	19	8112	5871	34942929
Aortic valve incompetence	32.31	16.81	19	8112	5885	34942915
Gait disturbance	31.00	16.81	64	8067	85076	34863724
Libido increased	29.43	16.81	10	8121	841	34947959
Supine hypertension	28.59	16.81	8	8123	351	34948449
Disorientation	27.20	16.81	36	8095	33152	34915648
Akinesia	26.46	16.81	12	8119	2172	34946628
Syncope	24.63	16.81	61	8070	91390	34857410
Mesenteric artery thrombosis	22.54	16.81	7	8124	442	34948358
Febrile neutropenia	21.80	16.81	3	8128	136846	34811954
Persecutory delusion	21.60	16.81	11	8120	2569	34946231
Diarrhoea	20.70	16.81	37	8094	389875	34558925
Obsessive-compulsive personality disorder	19.60	16.81	5	8126	153	34948647
Autonomic nervous system imbalance	18.84	16.81	10	8121	2541	34946259
Micrographia	18.81	16.81	3	8128	6	34948794
Serotonin syndrome	18.49	16.81	23	8108	19910	34928890
Restlessness	18.39	16.81	26	8105	25456	34923344
Illusion	18.36	16.81	7	8124	820	34947980
Mania	17.88	16.81	16	8115	9495	34939305
Tricuspid valve incompetence	17.53	16.81	16	8115	9744	34939056
Compulsions	17.49	16.81	5	8126	237	34948563
Soft tissue mass	16.94	16.81	7	8124	1012	34947788

FDA Adverse Event Reporting System (Geriatric)

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
Hallucination	300.07	15.63	177	11857	85568	79646786
Parkinson's disease	279.71	15.63	62	11972	1609	79730745
Dyskinesia	209.71	15.63	112	11922	44661	79687693
Hallucination, visual	194.13	15.63	96	11938	32633	79699721
Hypersexuality	157.71	15.63	39	11995	1641	79730713
Muscle rigidity	150.52	15.63	69	11965	19813	79712541
Gambling disorder	121.84	15.63	33	12001	1993	79730361
Confusional state	121.68	15.63	191	11843	317806	79414548
Agitation	106.65	15.63	101	11933	99614	79632740
On and off phenomenon	106.53	15.63	33	12001	3207	79729147
Fall	101.02	15.63	225	11809	487404	79244950
Tremor	98.97	15.63	125	11909	169958	79562396
Neuroleptic malignant syndrome	96.49	15.63	57	11977	27502	79704852
Abnormal behaviour	81.93	15.63	57	11977	36364	79695990
Delusion	81.50	15.63	46	11988	20377	79711977
Orthostatic hypotension	73.99	15.63	64	11970	56100	79676254
Aortic valve incompetence	71.87	15.63	33	12001	9497	79722857
Impulse-control disorder	70.90	15.63	21	12013	1753	79730601
Dopamine dysregulation syndrome	63.97	15.63	15	12019	502	79731852
Aggression	62.97	15.63	56	11978	50902	79681452
Parkinsonism	62.53	15.63	36	11998	16548	79715806
Off label use	60.33	15.63	31	12003	907184	78825170
Dementia	58.77	15.63	40	11994	24619	79707735
Psychotic disorder	58.24	15.63	49	11985	41353	79691001
Bradykinesia	58.00	15.63	27	12007	8016	79724338
Delirium	56.95	15.63	67	11967	84560	79647794
Somnolence	52.37	15.63	113	11921	238868	79493486
Product complaint	47.73	15.63	28	12006	13321	79719033
Gambling	44.03	15.63	10	12024	290	79732064
Disorientation	42.72	15.63	50	11984	62726	79669628
Sudden onset of sleep	41.12	15.63	11	12023	633	79731721
Tricuspid valve incompetence	40.04	15.63	29	12005	19683	79712671
Drug interaction	39.61	15.63	145	11889	415038	79317316
Dysphagia	39.31	15.63	68	11966	122068	79610286
Gait disturbance	38.62	15.63	92	11942	207414	79524940
Compulsive shopping	38.54	15.63	11	12023	805	79731549
Akinesia	36.53	15.63	15	12019	3297	79729057
Serotonin syndrome	34.25	15.63	38	11996	44989	79687365
Ileus	32.76	15.63	29	12005	26182	79706172
Syncope	31.71	15.63	78	11956	179371	79552983
Mitral valve incompetence	30.62	15.63	29	12005	28536	79703818
Diarrhoea	29.61	15.63	55	11979	880434	78851920
Purpura senile	28.93	15.63	8	12026	522	79731832
Tarsal tunnel syndrome	28.84	15.63	8	12026	528	79731826
Depressed level of consciousness	28.75	15.63	52	11982	96600	79635754
Speech disorder	28.45	15.63	38	11996	54407	79677947
Persecutory delusion	27.90	15.63	14	12020	4895	79727459
Movement disorder	26.07	15.63	26	12008	27233	79705121
Granulocytopenia	25.95	15.63	18	12016	11413	79720941
Supine hypertension	25.93	15.63	7	12027	417	79731937
Deep brain stimulation	25.74	15.63	5	12029	66	79732288
Blood creatine phosphokinase increased	25.57	15.63	40	11994	66050	79666304
Obsessive-compulsive disorder	25.41	15.63	14	12020	5913	79726441
Dementia with Lewy bodies	25.23	15.63	8	12026	838	79731516
Resorption bone increased	24.52	15.63	9	12025	1466	79730888
Vascular encephalopathy	23.27	15.63	7	12027	616	79731738
Mesenteric artery thrombosis	23.06	15.63	7	12027	635	79731719
Autonomic nervous system imbalance	22.83	15.63	12	12022	4618	79727736
Pain	22.72	15.63	45	11989	703757	79028597
Product use in unapproved indication	22.71	15.63	5	12029	250354	79482000
Obsessive-compulsive personality disorder	22.54	15.63	5	12029	130	79732224
Mania	22.41	15.63	20	12014	18240	79714114
Posture abnormal	21.89	15.63	11	12023	3855	79728499
Dystonia	21.56	15.63	21	12013	21378	79710976
Peripheral swelling	21.41	15.63	7	12027	269610	79462744
Abnormal dreams	21.40	15.63	16	12018	11396	79720958
Restlessness	20.63	15.63	30	12004	46462	79685892
Dysstasia	20.38	15.63	23	12011	27723	79704631
Mental status changes	19.87	15.63	36	11998	66923	79665431
Psychomotor hyperactivity	19.78	15.63	18	12016	16831	79715523
Sinusitis	19.67	15.63	3	12031	195498	79536856
Illusion	19.59	15.63	8	12026	1733	79730621
Aortic valve sclerosis	19.42	15.63	8	12026	1772	79730582
Coronary artery dissection	19.09	15.63	7	12027	1137	79731217
Reduced facial expression	19.06	15.63	9	12025	2756	79729598
Drug intolerance	19.05	15.63	8	12026	264111	79468243
Cerebral atrophy	19.00	15.63	13	12021	8062	79724292
Hallucinations, mixed	18.38	15.63	12	12022	6887	79725467
Alopecia	18.38	15.63	6	12028	231349	79501005
Febrile neutropenia	18.34	15.63	6	12028	230993	79501361
Soft tissue mass	18.28	15.63	7	12027	1281	79731073
Hepatic enzyme increased	17.93	15.63	3	12031	182607	79549747
Mitral valve disease	17.82	15.63	9	12025	3188	79729166
Pruritus	17.80	15.63	20	12014	394628	79337726
Balance disorder	17.47	15.63	43	11991	98814	79633540
Joint swelling	17.47	15.63	11	12023	288635	79443719
International normalised ratio increased	17.31	15.63	39	11995	84682	79647672
Drug hypersensitivity	17.26	15.63	12	12022	298904	79433450
Incoherent	17.20	15.63	12	12022	7680	79724674
Intermittent claudication	17.12	15.63	9	12025	3462	79728892
Chorea	17.07	15.63	8	12026	2409	79729945
Vestibular disorder	16.95	15.63	8	12026	2447	79729907
Anxiety	16.69	15.63	78	11956	248434	79483920
Treatment failure	16.30	15.63	3	12031	170483	79561871
Drug withdrawal syndrome	16.28	15.63	23	12011	34695	79697659
Delusion of replacement	16.25	15.63	4	12030	165	79732189
Urticaria	16.20	15.63	4	12030	185197	79547157
Dysarthria	15.96	15.63	33	12001	67589	79664765

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:48560	dopaminergic agents
CHEBI has role	CHEBI:59321	aromatic-L-amino-acid decarboxylase inhibitors
CHEBI has role	CHEBI:66956	antidyskinetic agent
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D065105	Aromatic Amino Acid Decarboxylase Inhibitors
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D015259	Dopamine Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D018377	Neurotransmitter Agents
FDA EPC	N0000175754	Aromatic Amino Acid Decarboxylation Inhibitor
FDA MoA	N0000175755	DOPA Decarboxylase Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Postencephalitic parkinsonism	indication	19972008	DOID:14332
Parkinsonism	indication	32798002
Parkinson's disease	indication	49049000	DOID:14330
Restless legs	off-label use	32914008	DOID:0050425
Suicidal thoughts	contraindication	6471006
Hallucinations	contraindication	7011001
Dyskinesia	contraindication	9748009
Peptic ulcer	contraindication	13200003	DOID:750
Disorder of lung	contraindication	19829001	DOID:850
Myocardial infarction	contraindication	22298006	DOID:5844
Orthostatic hypotension	contraindication	28651003
Obstruction of bile duct	contraindication	30144000
Depressive disorder	contraindication	35489007
Conduction disorder of the heart	contraindication	44808001
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Diarrhea	contraindication	62315008
Psychotic disorder	contraindication	69322001
Diabetes mellitus	contraindication	73211009	DOID:9351
Gastrointestinal hemorrhage	contraindication	74474003
Open-angle glaucoma	contraindication	84494001	DOID:1067
Kidney disease	contraindication	90708001	DOID:557
Cataract surgery	contraindication	110473004
Acute disease of cardiovascular system	contraindication	128487001
Seizure disorder	contraindication	128613002
Drug-induced psychosis	contraindication	191483003	DOID:1742
Disease of liver	contraindication	235856003	DOID:409
Retention of urine	contraindication	267064002
Psychoneurotic personality disorder	contraindication	268634009
Malignant melanoma	contraindication	372244006
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Cardiovascular event risk	contraindication	395112001
Gastric ulcer	contraindication	397825006	DOID:10808
Intraoperative floppy iris syndrome	contraindication	418801006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.4	acidic
pKa2	10.49	acidic
pKa3	13.92	acidic
pKa4	7.18	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
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9463246	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9533046	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
23.75MG;95MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9901640	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9463246	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9533046	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
36.25MG;145MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9901640	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9463246	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9533046	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
48.75MG;195MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9901640	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8377474	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8454998	Dec. 26, 2028	TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	8557283	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9089607	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9463246	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9533046	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
61.25MG;245MG	RYTARY	IMPAX LABS INC	N203312	Jan. 7, 2015	RX	CAPSULE, EXTENDED RELEASE	ORAL	9901640	Dec. 26, 2028	TREATMENT OF PARKINSONS DISEASE
25MG;100MG	DHIVY	AVION PHARMS	N214869	Nov. 12, 2021	RX	TABLET	ORAL	11033521	March 28, 2039	METHOD OF TREATING PARKINSONS DISEASE BY ORALLY ADMINISTERING A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG
25MG;100MG	DHIVY	AVION PHARMS	N214869	Nov. 12, 2021	RX	TABLET	ORAL	11033521	March 28, 2039	METHOD OF TREATING PARKINSONS DISEASE BY ORALLY ADMINISTERING SEGMENTS OF A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG, EACH SEGMENT HAVING CARBIDOPA—6.25 MG/LEVODOPA—25 MG
25MG;100MG	DHIVY	AVION PHARMS	N214869	Nov. 12, 2021	RX	TABLET	ORAL	11033521	March 28, 2039	TREATMENT OF PARKINSONS DISEASE
25MG;100MG	DHIVY	AVION PHARMS	N214869	Nov. 12, 2021	RX	TABLET	ORAL	11439613	March 28, 2039	TREATMENT OF PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND SYMPTOMATIC PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Aromatic-L-amino-acid decarboxylase	Enzyme	P20711	DDC_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	5.17	DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.43	DRUG MATRIX
Lysine-specific demethylase 4E	Enzyme	B2RXH2	KDM4E_HUMAN		Ki	5.70	CHEMBL

External reference:

ID	Source
4017949	VUID
N0000146299	NUI
D00558	KEGG_DRUG
2019	RXNORM
C0006982	UMLSCUI
CHEBI:3395	CHEBI
142	PDB_CHEM_ID
CHEMBL1200748	ChEMBL_ID
CHEMBL1201236	ChEMBL_ID
DB00190	DRUGBANK_ID
D002230	MESH_DESCRIPTOR_UI
34359	PUBCHEM_CID
5159	IUPHAR_LIGAND_ID
MNX7R8C5VO	UNII
31531	MMSL
4355	MMSL
71847	MMSL
d00184	MMSL
386107009	SNOMEDCT_US
73579000	SNOMEDCT_US
4017949	VANDF
38821-49-7	SECONDARY_CAS_RN
001085	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3915	TABLET	10 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3916	TABLET	25 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3917	TABLET	25 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6722	TABLET	10 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6723	TABLET	25 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6724	TABLET	25 mg	ORAL	NDA	25 sections
Duopa	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3012	SUSPENSION	4.63 mg	ENTERAL	NDA	31 sections
Duopa	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3012	SUSPENSION	4.63 mg	ENTERAL	NDA	31 sections
Duopa	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3012	SUSPENSION	4.63 mg	ENTERAL	NDA	31 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0407	TABLET, FILM COATED	12.50 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0408	TABLET, FILM COATED	25 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0409	TABLET, FILM COATED	37.50 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0527	TABLET, FILM COATED	50 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0544	TABLET, FILM COATED	18.75 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0545	TABLET, FILM COATED	31.25 mg	ORAL	NDA	25 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0093-9701	TABLET	10 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0093-9701	TABLET	10 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0093-9702	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0093-9702	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2538	TABLET	10 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2538	TABLET	10 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2539	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2539	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2540	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2540	TABLET	25 mg	ORAL	ANDA	11 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0078	TABLET	10 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0078	TABLET	10 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0085	TABLET	25 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0085	TABLET	25 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0088	TABLET, EXTENDED RELEASE	25 mg	ORAL	ANDA	24 sections