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

Stem definition	Drug id	CAS RN
catechol-O-methyltransferase (COMT) inhibitors	1018	130929-57-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: entacapone entacom comtess	Entacapone is a selective and reversible inhibitor of COMT. COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include dopa, catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. The function of COMT is the elimination of biologically active catechols and some other hydroxylated metabolites. When entacapone is given in conjunction with levodopa and an aromatic amino acid decarboxylase inhibitor, such as carbidopa, plasma levels of levodopa are greater and more sustained than after administration of levodopa and an aromatic amino acid decarboxylase inhibitor alone. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain, leading to greater effects on the signs and symptoms of Parkinson's disease. Molecular weight: 305.29 Formula: C14H15N3O5 CLOGP: 1.76 LIPINSKI: 0 HAC: 8 HDO: 2 TPSA: 130.38 ALOGS: -3.58 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

entacapone
entacom
comtess

Entacapone is a selective and reversible inhibitor of COMT. COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include dopa, catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. The function of COMT is the elimination of biologically active catechols and some other hydroxylated metabolites. When entacapone is given in conjunction with levodopa and an aromatic amino acid decarboxylase inhibitor, such as carbidopa, plasma levels of levodopa are greater and more sustained than after administration of levodopa and an aromatic amino acid decarboxylase inhibitor alone. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain, leading to greater effects on the signs and symptoms of Parkinson's disease.

Molecular weight: 305.29
Formula: C14H15N3O5
CLOGP: 1.76
LIPINSKI: 0
HAC: 8
HDO: 2
TPSA: 130.38
ALOGS: -3.58
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.20 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	87.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	42 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.27 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	12 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)	2.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 19, 1999	FDA	ORION PHARMA

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
Dyskinesia	564.42	22.81	199	7254	31634	53309979
Hallucination	394.69	22.81	178	7275	53660	53287953
On and off phenomenon	242.42	22.81	59	7394	2519	53339094
Hallucination, visual	192.79	22.81	79	7374	18753	53322860
Muscle rigidity	151.52	22.81	57	7396	10784	53330829
Therapeutic response shortened	132.01	22.81	46	7407	6993	53334620
Freezing phenomenon	120.92	22.81	31	7422	1636	53339977
Delusion	118.17	22.81	49	7404	11960	53329653
Psychotic disorder	112.87	22.81	59	7394	24326	53317287
Dysphagia	111.31	22.81	93	7360	84304	53257309
Akinesia	97.13	22.81	27	7426	1944	53339669
Sudden onset of sleep	92.71	22.81	21	7432	652	53340961
Dopamine dysregulation syndrome	91.25	22.81	18	7435	281	53341332
Tremor	90.20	22.81	99	7354	125637	53215976
Dystonia	88.65	22.81	41	7412	12980	53328633
Stoma site discharge	88.00	22.81	26	7427	2328	53339285
Fall	87.60	22.81	169	7284	358271	52983342
Wrong technique in product usage process	87.17	22.81	70	7383	59962	53281651
Impulse-control disorder	83.27	22.81	20	7433	805	53340808
Bradykinesia	79.89	22.81	28	7425	4325	53337288
Confusional state	78.74	22.81	115	7338	194106	53147507
Compulsive shopping	68.01	22.81	17	7436	809	53340804
Gait disturbance	62.79	22.81	93	7360	158749	53182864
Delirium	61.58	22.81	49	7404	41380	53300233
Ileus	60.22	22.81	33	7420	14922	53326691
Stoma site erythema	57.64	22.81	17	7436	1512	53340101
Orthostatic hypotension	57.09	22.81	41	7412	29712	53311901
Dementia	56.73	22.81	33	7420	16717	53324896
Stereotypy	51.31	22.81	12	7441	430	53341183
Stoma site pain	51.00	22.81	15	7438	1321	53340292
Acute psychosis	49.70	22.81	17	7436	2441	53339172
Speech disorder	49.15	22.81	42	7411	39139	53302474
Parkinson's disease	48.98	22.81	15	7438	1516	53340097
Hyperkinesia	48.59	22.81	16	7437	2044	53339569
Camptocormia	48.54	22.81	11	7442	342	53341271
Psychomotor hyperactivity	48.32	22.81	25	7428	10071	53331542
Parkinsonian crisis	43.87	22.81	7	7446	28	53341585
Parkinsonism	39.38	22.81	21	7432	8992	53332621
Restlessness	39.13	22.81	32	7421	28055	53313558
Stoma site infection	37.55	22.81	11	7442	955	53340658
Rash	36.11	22.81	9	7444	446182	52895431
Vascular encephalopathy	35.65	22.81	9	7444	446	53341167
Femoral neck fracture	35.14	22.81	19	7434	8364	53333249
Reduced facial expression	34.95	22.81	12	7441	1742	53339871
Neuroleptic malignant syndrome	33.73	22.81	21	7432	12012	53329601
Pleurothotonus	33.69	22.81	11	7442	1368	53340245
Agitation	33.30	22.81	41	7412	58585	53283028
Rheumatoid arthritis	33.00	22.81	3	7450	314528	53027085
Abnormal behaviour	32.77	22.81	26	7427	21840	53319773
Somnolence	31.29	22.81	71	7382	167663	53173950
Subileus	31.21	22.81	13	7440	3203	53338410
Choking	30.68	22.81	18	7435	9258	53332355
Therapeutic product effect variable	30.62	22.81	10	7443	1245	53340368
Gambling disorder	29.55	22.81	10	7443	1390	53340223
Balance disorder	29.05	22.81	43	7410	73164	53268449
Nocturia	28.38	22.81	16	7437	7634	53333979
Chromaturia	28.36	22.81	21	7432	15929	53325684
Depressed level of consciousness	27.63	22.81	36	7417	54392	53287221
Nightmare	26.37	22.81	21	7432	17730	53323883
Stoma site extravasation	26.35	22.81	7	7446	424	53341189
Arthralgia	25.44	22.81	15	7438	439768	52901845
Hypokinesia	25.09	22.81	18	7435	13009	53328604
Posture abnormal	24.53	22.81	10	7443	2333	53339280
Pneumonia aspiration	24.51	22.81	27	7426	34274	53307339
Stoma site hypergranulation	24.39	22.81	7	7446	565	53341048
Abnormal dreams	23.57	22.81	16	7437	10585	53331028
Movement disorder	23.36	22.81	20	7433	18661	53322952
Dropped head syndrome	23.11	22.81	5	7448	125	53341488

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
Hallucination	478.33	19.67	269	10897	52350	32450010
Dyskinesia	418.94	19.67	190	10976	23413	32478947
On and off phenomenon	257.30	19.67	80	11086	3421	32498939
Hypersexuality	253.25	19.67	67	11099	1590	32500770
Hallucination, visual	251.16	19.67	121	11045	17038	32485322
Gambling disorder	217.62	19.67	61	11105	1808	32500552
Muscle rigidity	207.56	19.67	93	11073	11093	32491267
Freezing phenomenon	199.16	19.67	60	11106	2303	32500057
Dysphagia	179.95	19.67	157	11009	61319	32441041
Fall	150.67	19.67	253	10913	195948	32306412
Parkinson's disease	150.52	19.67	45	11121	1681	32500679
Delusion	137.89	19.67	74	11092	13034	32489326
Confusional state	128.04	19.67	198	10968	142917	32359443
Impulse-control disorder	124.81	19.67	38	11128	1511	32500849
Bradykinesia	124.33	19.67	49	11117	4237	32498123
Dopamine dysregulation syndrome	117.69	19.67	29	11137	512	32501848
Akinesia	112.55	19.67	40	11126	2593	32499767
Aggression	98.18	19.67	92	11074	39297	32463063
Device dislocation	83.34	19.67	41	11125	6022	32496338
Cognitive disorder	81.43	19.67	69	11097	25825	32476535
Tremor	77.51	19.67	116	11050	81161	32421199
Gait disturbance	77.02	19.67	115	11051	80293	32422067
Psychotic disorder	75.80	19.67	63	11103	22957	32479403
Agitation	73.01	19.67	94	11072	57142	32445218
Stoma site discharge	70.16	19.67	26	11140	1899	32500461
Hyperkinesia	69.38	19.67	27	11139	2255	32500105
Dementia	69.28	19.67	48	11118	13338	32489022
Neuroleptic malignant syndrome	68.50	19.67	53	11113	17442	32484918
Jealous delusion	66.22	19.67	16	11150	259	32502101
Stereotypy	59.69	19.67	18	11148	692	32501668
Abnormal behaviour	56.84	19.67	57	11109	26409	32475951
Reduced facial expression	55.37	19.67	18	11148	888	32501472
Stoma site erythema	55.06	19.67	20	11146	1380	32500980
Embedded device	54.72	19.67	17	11149	723	32501637
Delirium	54.05	19.67	71	11095	43975	32458385
Compulsive shopping	53.31	19.67	15	11151	450	32501910
Pneumonia aspiration	51.52	19.67	67	11099	41089	32461271
Device occlusion	48.73	19.67	30	11136	6828	32495532
Wrong technique in product usage process	48.51	19.67	60	11106	34999	32467361
Paranoia	47.32	19.67	35	11131	10764	32491596
Posture abnormal	46.36	19.67	20	11146	2173	32500187
Psychomotor hyperactivity	45.80	19.67	32	11134	9007	32493353
Mobility decreased	43.18	19.67	51	11115	28358	32474002
Choking	42.94	19.67	25	11141	5141	32497219
Stoma site pain	42.77	19.67	15	11151	934	32501426
Abnormal dreams	42.65	19.67	30	11136	8534	32493826
Device issue	41.57	19.67	30	11136	8882	32493478
Dystonia	41.17	19.67	32	11134	10591	32491769
Therapeutic response shortened	39.65	19.67	23	11143	4697	32497663
Stoma site infection	39.02	19.67	15	11151	1212	32501148
Somnolence	38.99	19.67	100	11066	103697	32398663
Libido increased	36.43	19.67	13	11153	852	32501508
Anticholinergic syndrome	35.93	19.67	13	11153	887	32501473
Acute kidney injury	35.89	19.67	29	11137	293439	32208921
Motor dysfunction	35.27	19.67	24	11142	6472	32495888
Sudden onset of sleep	35.09	19.67	11	11155	482	32501878
Oesophageal achalasia	33.47	19.67	10	11156	372	32501988
Illusion	33.20	19.67	12	11154	816	32501544
Balance disorder	32.90	19.67	53	11113	39406	32462954
Persecutory delusion	32.68	19.67	16	11150	2323	32500037
Intentional medical device removal by patient	32.37	19.67	10	11156	417	32501943
Therapeutic product effect decreased	32.00	19.67	46	11120	30971	32471389
Parkinsonism hyperpyrexia syndrome	31.90	19.67	8	11158	152	32502208
Hypersomnia	31.81	19.67	29	11137	11932	32490428
Nightmare	31.32	19.67	30	11136	13136	32489224
Therapeutic product effect variable	31.28	19.67	15	11151	2081	32500279
Sleep talking	30.65	19.67	10	11156	499	32501861
Memory impairment	30.57	19.67	52	11114	40427	32461933
Musculoskeletal stiffness	30.39	19.67	51	11115	39213	32463147
Depressed mood	29.72	19.67	34	11132	18266	32484094
Immobile	29.04	19.67	15	11151	2439	32499921
Soft tissue mass	28.78	19.67	9	11157	391	32501969
Device kink	28.17	19.67	10	11156	645	32501715
Febrile neutropenia	27.81	19.67	4	11162	119562	32382798
Hypokinesia	27.64	19.67	23	11143	8382	32493978
Stoma site haemorrhage	27.09	19.67	11	11155	1027	32501333
Orthostatic hypotension	26.40	19.67	38	11128	25612	32476748
Obsessive-compulsive disorder	26.24	19.67	18	11148	4916	32497444
Movement disorder	26.06	19.67	25	11141	10966	32491394
Renal failure	26.05	19.67	7	11159	134471	32367889
Restlessness	25.81	19.67	37	11129	24844	32477516
Thunderclap headache	25.32	19.67	6	11160	89	32502271
Parkinsonism	24.78	19.67	21	11145	7848	32494512
Hyperthermia	24.68	19.67	24	11142	10704	32491656
Gambling	24.41	19.67	7	11159	225	32502135
Anxiety	23.98	19.67	80	11086	95925	32406435
Tricuspid valve sclerosis	23.91	19.67	5	11161	40	32502320
Depressive symptom	23.85	19.67	12	11154	1846	32500514
Somatic delusion	23.23	19.67	6	11160	129	32502231
Neutropenia	23.04	19.67	10	11156	142165	32360195
Underdose	22.44	19.67	25	11141	13044	32489316
Mitral valve sclerosis	22.22	19.67	6	11160	154	32502206
Platelet count decreased	22.12	19.67	6	11160	114585	32387775
Impulsive behaviour	22	19.67	12	11154	2177	32500183
Nasal discomfort	21.77	19.67	10	11156	1259	32501101
Product use complaint	21.73	19.67	10	11156	1264	32501096
Progressive supranuclear palsy	21.71	19.67	5	11161	65	32502295
Dyspnoea	21.55	19.67	59	11107	361986	32140374
Dysstasia	21.51	19.67	23	11143	11463	32490897
Pancytopenia	21.33	19.67	3	11163	91232	32411128
Toxicity to various agents	21.22	19.67	18	11148	178023	32324337
Gait inability	21.07	19.67	30	11136	20017	32482343
Pelvic fracture	21.02	19.67	12	11154	2376	32499984
Pruritus	20.93	19.67	9	11157	128693	32373667
Gastric fistula	20.69	19.67	5	11161	81	32502279
Off label use	20.48	19.67	47	11119	306273	32196087
Feeling abnormal	20.40	19.67	56	11110	60367	32441993
Autonomic nervous system imbalance	20.25	19.67	12	11154	2548	32499812
Device breakage	20.18	19.67	11	11155	1993	32500367
Saliva discolouration	19.99	19.67	4	11162	25	32502335
Gastrointestinal haemorrhage	19.98	19.67	3	11163	86879	32415481

Pharmacologic Action:

Source	Code	Description
ATC	N04BX02	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Other dopaminergic agents
CHEBI has role	CHEBI:35470	CNS agent
CHEBI has role	CHEBI:48406	catechol O-methyltransferase inhibitors
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:66956	antidyskinetic drugs
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D065098	Catechol O-Methyltransferase Inhibitors
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D004791	Enzyme Inhibitors
FDA MoA	N0000175756	Catechol O-Methyltransferase Inhibitors
FDA EPC	N0000175757	Catechol-O-Methyltransferase Inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Parkinson's disease	indication	49049000	DOID:14330
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
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
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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.41	acidic
pKa2	13.34	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Catechol O-methyltransferase	Enzyme	P21964	COMT_HUMAN	INHIBITOR	Ki	9.52	SCIENTIFIC LITERATURE	CHEMBL
G-protein coupled receptor 35	GPCR	Q9HC97	GPR35_HUMAN		EC50	5.25	CHEMBL
Alpha-ketoglutarate-dependent dioxygenase FTO	Unclassified	Q9C0B1	FTO_HUMAN		IC50	5.52	CHEMBL
Catechol O-methyltransferase	Enzyme		COMT_RAT		IC50	7.89	CHEMBL

External reference:

ID	Source
4021181	VUID
N0000148629	NUI
D00781	KEGG_DRUG
4021181	VANDF
C0165921	UMLSCUI
CHEBI:4798	CHEBI
PD9	PDB_CHEM_ID
CHEMBL953	ChEMBL_ID
DB00494	DRUGBANK_ID
C071192	MESH_SUPPLEMENTAL_RECORD_UI
5281081	PUBCHEM_CID
6647	IUPHAR_LIGAND_ID
6812	INN_ID
4975G9NM6T	UNII
227109	RXNORM
66346	MMSL
8477	MMSL
d04460	MMSL
007684	NDDF
116116003	SNOMEDCT_US
387018000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Comtan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0327	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0407	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0408	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0409	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0527	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0544	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0545	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8300	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8301	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8302	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8303	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8304	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8305	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Entacapone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9080	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	21 sections
Entacapone	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1830	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
Entacapone	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8298	TABLET	200 mg	ORAL	ANDA	19 sections
Entacapone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5578	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	13 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5613	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5625	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5637	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5641	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5654	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Carbidopa, Levodopa, and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0781-5669	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	26 sections
Entacapone	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6822	TABLET, FILM COATED	200 mg	ORAL	ANDA	20 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-689	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-690	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-691	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-692	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-693	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE	Human Prescription Drug Label	3	16571-694	TABLET, FILM COATED	200 mg	ORAL	ANDA	26 sections