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

Stem definitionDrug idCAS RN
946 120014-06-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aricept
  • donepezil
  • donepezil hydrochloride
  • donepezil HCl
  • donezpil hydrochloride
  • donezpil
  • donezpil HCl
  • donepezilium oxalate trihydrate
  • donepezilium oxalate
  • donepezil oxalate
  • E2020
  • E-2020
An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.
  • Molecular weight: 379.50
  • Formula: C24H29NO3
  • CLOGP: 4.60
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 38.77
  • ALOGS: -4.93
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10.60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.38 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Nov. 25, 1996 FDA EISAI INC

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
Bradycardia 958.29 47.56 242 2808 9739 2345296
Syncope 523.46 47.56 170 2880 16705 2338330
Electrocardiogram QT prolonged 505.31 47.56 139 2911 7675 2347360
Fall 484.50 47.56 211 2839 46888 2308147
Drug interaction 393.94 47.56 159 2891 29004 2326031
Confusional state 357.21 47.56 141 2909 24203 2330832
Vomiting 302.96 47.56 176 2874 71426 2283609
Sinus bradycardia 275.93 47.56 66 2984 2050 2352985
Torsade de pointes 272.01 47.56 66 2984 2180 2352855
Decreased appetite 255.59 47.56 117 2933 28774 2326261
Seizure 241.47 47.56 107 2943 24359 2330676
Loss of consciousness 200.94 47.56 87 2963 18680 2336355
Dementia Alzheimer's type 200.51 47.56 43 3007 803 2354232
Agitation 197.12 47.56 74 2976 10977 2344058
Dementia 183.38 47.56 50 3000 2631 2352404
Pleurothotonus 183.21 47.56 33 3017 233 2354802
Nausea 175.02 47.56 150 2900 112039 2242996
Sinus node dysfunction 174.26 47.56 37 3013 657 2354378
Somnolence 173.12 47.56 84 2966 23401 2331634
Hallucination 172.77 47.56 62 2988 8086 2346949
Delusion 162.35 47.56 43 3007 2022 2353013
Abnormal behaviour 159.14 47.56 51 2999 4709 2350326
Dizziness 156.16 47.56 108 2942 58557 2296478
Tremor 155.52 47.56 75 2975 20586 2334449
Neuroleptic malignant syndrome 152.56 47.56 41 3009 2039 2352996
Aggression 146.64 47.56 48 3002 4738 2350297
Cognitive disorder 145.06 47.56 49 3001 5332 2349703
Hypokalaemia 142.70 47.56 58 2992 10596 2344439
Delirium 142.52 47.56 48 3002 5175 2349860
Atrioventricular block first degree 140.74 47.56 33 3017 934 2354101
Completed suicide 133.46 47.56 68 2982 20966 2334069
Mania 132.51 47.56 38 3012 2402 2352633
Depressed level of consciousness 132.12 47.56 50 3000 7554 2347481
Atrioventricular block complete 128.28 47.56 33 3017 1381 2353654
Hypotension 126.34 47.56 76 2974 32360 2322675
Altered state of consciousness 115.34 47.56 38 3012 3822 2351213
Disorientation 114.66 47.56 43 3007 6329 2348706
Rhabdomyolysis 112.53 47.56 43 3007 6661 2348374
Diarrhoea 110.35 47.56 102 2948 83462 2271573
Circulatory collapse 108.65 47.56 36 3014 3684 2351351
Dehydration 107.34 47.56 60 2990 22235 2332800
Parkinsonism 107.20 47.56 29 3021 1476 2353559
Medication error 105.33 47.56 40 3010 6091 2348944
Malaise 104.17 47.56 83 2967 55502 2299533
Hallucination, visual 103.96 47.56 33 3017 2946 2352089
Extrapyramidal disorder 103.03 47.56 31 3019 2316 2352719
Toxicity to various agents 93.21 47.56 63 2987 32691 2322344
Torticollis 88.77 47.56 19 3031 350 2354685
Cardiac arrest 88.04 47.56 46 3004 14884 2340151
Sudden death 87.84 47.56 26 3024 1834 2353201
Ventricular tachycardia 87.35 47.56 29 3021 2982 2352053
Hyponatraemia 87.08 47.56 44 3006 13281 2341754
Weight decreased 86.55 47.56 57 2993 28314 2326721
Sinus arrest 86.31 47.56 18 3032 291 2354744
Psychomotor hyperactivity 82.68 47.56 25 3025 1897 2353138
Cholinergic syndrome 80.54 47.56 14 3036 78 2354957
Condition aggravated 80.35 47.56 57 2993 31922 2323113
Anal incontinence 80.33 47.56 24 3026 1748 2353287
Atrioventricular block 79.91 47.56 22 3028 1195 2353840
Miosis 79.78 47.56 22 3028 1202 2353833
Urinary incontinence 77.69 47.56 29 3021 4204 2350831
Memory impairment 76.70 47.56 40 3010 12883 2342152
Gastrointestinal haemorrhage 75.26 47.56 39 3011 12396 2342639
Cardio-respiratory arrest 74.13 47.56 35 3015 9111 2345924
Nightmare 74.01 47.56 27 3023 3670 2351365
Hypomania 73.98 47.56 19 3031 788 2354247
Speech disorder 72.35 47.56 31 3019 6433 2348602
Atrial fibrillation 71.52 47.56 39 3011 13729 2341306
Muscle rigidity 71.03 47.56 22 3028 1809 2353226
Unresponsive to stimuli 70.21 47.56 28 3022 4848 2350187
Myoclonus 68.38 47.56 23 3027 2460 2352575
Electrocardiogram PR prolongation 68.19 47.56 13 3037 129 2354906
Colitis microscopic 66.47 47.56 18 3032 918 2354117
Encephalopathy 61.54 47.56 25 3025 4536 2350499
Accidental overdose 61.35 47.56 24 3026 3948 2351087
Hepatic function abnormal 60.95 47.56 27 3023 6065 2348970
Overdose 60.64 47.56 40 3010 19867 2335168
Insomnia 60.22 47.56 44 3006 25743 2329292
Heart rate decreased 59.57 47.56 23 3027 3653 2351382
Acute kidney injury 59.02 47.56 45 3005 28077 2326958
Orthostatic hypotension 57.52 47.56 21 3029 2858 2352177
Neuropsychiatric symptoms 57.18 47.56 10 3040 58 2354977
General physical health deterioration 57.14 47.56 34 3016 14105 2340930
Femoral neck fracture 56.30 47.56 17 3033 1282 2353753
Gait disturbance 56.13 47.56 40 3010 22505 2332530
Hypersexuality 55.48 47.56 11 3039 136 2354899
Asthenia 55.39 47.56 54 2996 46872 2308163
Long QT syndrome 55.01 47.56 14 3036 559 2354476
Generalised tonic-clonic seizure 54.35 47.56 24 3026 5348 2349687
Anxiety 53.01 47.56 43 3007 29316 2325719
Hypophagia 50.81 47.56 21 3029 3979 2351056
Hyperhidrosis 49.42 47.56 32 3018 15390 2339645
Haematoma 48.99 47.56 22 3028 5099 2349936
Arrhythmia 48.61 47.56 23 3027 6005 2349030
Depression 48.26 47.56 40 3010 28092 2326943
Coma 47.96 47.56 26 3024 9030 2346005
Sinoatrial block 47.74 47.56 10 3040 165 2354870

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
Bradycardia 621.55 40.19 177 1841 10357 1734406
Syncope 312.13 40.19 113 1905 14056 1730707
Confusional state 308.46 40.19 125 1893 21153 1723610
Fall 304.82 40.19 133 1885 27081 1717682
Delirium 268.75 40.19 83 1935 6279 1738484
Agitation 223.98 40.19 83 1935 10943 1733820
Drug interaction 210.49 40.19 104 1914 27854 1716909
Aggression 175.32 40.19 64 1954 8051 1736712
Rhabdomyolysis 173.18 40.19 69 1949 11021 1733742
Sinus bradycardia 171.06 40.19 45 1973 1888 1742875
Somnolence 155.16 40.19 72 1946 16667 1728096
Neuroleptic malignant syndrome 145.04 40.19 44 1974 3104 1741659
Electrocardiogram QT prolonged 135.67 40.19 48 1970 5497 1739266
Cognitive disorder 131.24 40.19 44 1974 4286 1740477
Vomiting 130.63 40.19 85 1933 38230 1706533
Dizziness 128.93 40.19 81 1937 34280 1710483
Cholinergic syndrome 125.36 40.19 22 1996 118 1744645
Mania 125.30 40.19 36 1982 2097 1742666
Sinus node dysfunction 121.62 40.19 28 1990 666 1744097
Hallucination 121.01 40.19 49 1969 8121 1736642
Dementia Alzheimer's type 119.71 40.19 27 1991 584 1744179
Depressed level of consciousness 116.74 40.19 45 1973 6547 1738216
Loss of consciousness 113.36 40.19 56 1962 14819 1729944
Hyperhidrosis 113.30 40.19 53 1965 12435 1732328
Dementia 112.57 40.19 33 1985 2063 1742700
Urinary incontinence 103.90 40.19 33 1985 2703 1742060
Seizure 101.99 40.19 58 1960 20383 1724380
Pleurothotonus 101.90 40.19 19 1999 150 1744613
Abnormal behaviour 100.65 40.19 40 1978 6302 1738461
Nightmare 99.19 40.19 32 1986 2755 1742008
Diarrhoea 94.13 40.19 80 1938 53772 1690991
Tremor 89.88 40.19 46 1972 13085 1731678
Condition aggravated 89.62 40.19 54 1964 21096 1723667
Decreased appetite 86.08 40.19 55 1963 23816 1720947
Extrapyramidal disorder 83.37 40.19 27 1991 2350 1742413
Serotonin syndrome 83.08 40.19 28 1990 2760 1742003
Restlessness 81.82 40.19 31 1987 4290 1740473
Gait disturbance 74.18 40.19 40 1978 12630 1732133
Hallucination, visual 73.17 40.19 25 1993 2567 1742196
Delusion 72.81 40.19 24 1994 2207 1742556
Parkinsonism 71.03 40.19 21 1997 1348 1743415
Atrioventricular block complete 69.54 40.19 21 1997 1450 1743313
Miosis 65.17 40.19 20 1998 1458 1743305
Insomnia 64.85 40.19 40 1978 16236 1728527
Dyskinesia 63.72 40.19 25 1993 3794 1740969
Pneumonia aspiration 62.45 40.19 27 1991 5239 1739524
Atrioventricular block first degree 60.32 40.19 17 2001 919 1743844
Sudden death 58.92 40.19 22 1996 2918 1741845
Nausea 58.19 40.19 60 1958 51136 1693627
Cold sweat 57.62 40.19 19 1999 1747 1743016
Salivary hypersecretion 56.93 40.19 18 2000 1447 1743316
Psychomotor hyperactivity 56.33 40.19 19 1999 1874 1742889
Toxicity to various agents 56.27 40.19 46 1972 29095 1715668
Irritability 54.79 40.19 25 1993 5507 1739256
Inappropriate antidiuretic hormone secretion 53.81 40.19 18 2000 1730 1743033
Cardiac arrest 53.11 40.19 35 1983 15895 1728868
Altered state of consciousness 51.75 40.19 21 1997 3476 1741287
Muscle contractions involuntary 51.13 40.19 13 2005 472 1744291
Arrhythmia 49.73 40.19 24 1994 5992 1738771
Acute kidney injury 49.02 40.19 46 1972 34898 1709865
Accidental overdose 48.21 40.19 21 1997 4143 1740620
Dehydration 47.52 40.19 34 1984 17624 1727139
Memory impairment 47.41 40.19 24 1994 6639 1738124
Post-traumatic stress disorder 46.43 40.19 11 2007 296 1744467
Unresponsive to stimuli 46.08 40.19 21 1997 4608 1740155
Duodenal ulcer 45.87 40.19 16 2002 1744 1743019
Asthenia 45.50 40.19 44 1974 34626 1710137
Hypotension 45.38 40.19 41 1977 29613 1715150
Myoclonus 45.34 40.19 17 2001 2278 1742485
Completed suicide 45.25 40.19 32 1986 16280 1728483
Muscle rigidity 45.11 40.19 16 2002 1832 1742931
Hypomania 44.62 40.19 12 2006 544 1744219
Loss of personal independence in daily activities 44.61 40.19 17 2001 2382 1742381
General physical health deterioration 44.13 40.19 29 1989 13089 1731674
Bradyarrhythmia 44.04 40.19 11 2007 371 1744392
Mental status changes 43.56 40.19 22 1996 6053 1738710
Hyponatraemia 43.29 40.19 25 1993 8975 1735788
Atrioventricular block second degree 43.06 40.19 12 2006 622 1744141
Gastrointestinal haemorrhage 41.92 40.19 29 1989 14238 1730525

Pharmacologic Action:

SourceCodeDescription
ATC N06DA02 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
ATC N06DA52 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
ATC N06DA53 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
FDA EPC N0000175723 Cholinesterase Inhibitor
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D002800 Cholinesterase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018697 Nootropic Agents
CHEBI has role CHEBI:66980 nootropic agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Alzheimer's disease indication 26929004 DOID:10652
Moderate to Severe Alzheimer's Type Dementia indication
Diffuse Lewy body disease off-label use 80098002
Sick sinus syndrome contraindication 36083008 DOID:13884
Gastrointestinal ulcer contraindication 40845000
Sinus bradycardia contraindication 49710005
Gastrointestinal hemorrhage contraindication 74474003
Epilepsy contraindication 84757009 DOID:1826
Asthma contraindication 195967001 DOID:2841
Atrioventricular block contraindication 233917008 DOID:0050820
Bladder outflow obstruction contraindication 236645006
NSAID-Induced Gastric Ulcer contraindication
Chronic Obstructive Pulmonary Disease with Bronchospasms contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8338486 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
10MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Acetylcholinesterase Enzyme INHIBITOR Ki 7.80 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.05 WOMBAT-PK
Amine oxidase [flavin-containing] B Enzyme IC50 4.82 CHEMBL
Beta-secretase 1 Enzyme IC50 5.49 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.84 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.70 CHEMBL
Cholinesterase Enzyme Ki 4.90 CHEMBL
Histamine H3 receptor GPCR IC50 6.46 CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.46 CHEMBL
Acetylcholinesterase Enzyme IC50 8.24 CHEMBL
Acetylcholinesterase Enzyme IC50 8.77 CHEMBL
Acetylcholinesterase Enzyme Ki 8.54 CHEMBL
Acetylcholinesterase Enzyme IC50 8.24 CHEMBL
Choline O-acetyltransferase Enzyme IC50 8.28 CHEMBL
Butyrylcholinesterase; Protein Bche Enzyme IC50 5.56 CHEMBL
Cholinesterase Enzyme IC50 6.08 CHEMBL
Amine oxidase [flavin-containing] B Enzyme IC50 4.82 CHEMBL
Butyrylcholinesterase Enzyme Ki 6.19 CHEMBL
Acetylcholinesterase Enzyme Ki 7.25 CHEMBL

External reference:

IDSource
D000077265 MESH_DESCRIPTOR_UI
C0527315 UMLSCUI
D00670 KEGG_DRUG
3O2T2PJ89D UNII
120011-70-3 SECONDARY_CAS_RN
108497001 SNOMEDCT_US
4024045 VANDF
006295 NDDF
d04099 MMSL
4631 MMSL
135447 RXNORM
386855006 SNOMEDCT_US
7517 INN_ID
CHEMBL502 ChEMBL_ID
DB00843 DRUGBANK_ID
CHEMBL1678 ChEMBL_ID
E20 PDB_CHEM_ID
CHEBI:53289 CHEBI
6599 IUPHAR_LIGAND_ID
3152 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9747 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9748 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-4529 TABLET, FILM COATED 23 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-1025 TABLET, FILM COATED 23 mg ORAL ANDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1207 CAPSULE 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1214 CAPSULE 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1221 CAPSULE 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1228 CAPSULE 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 10 mg ORAL NDA 17 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 8 0456-1229 KIT 10 mg ORAL NDA 17 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7623 TABLET, FILM COATED 5 mg ORAL NDA 18 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7624 TABLET, FILM COATED 10 mg ORAL NDA 18 sections
Donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7653 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7654 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7842 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7843 TABLET 5 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7951 TABLET, FILM COATED 5 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7952 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8313 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5274 TABLET 5 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5275 TABLET 10 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5276 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5277 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 17 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6477 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6478 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-103 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
DONEPEZIL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24724-028 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
DONEPEZIL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24724-029 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections