primidone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
2267 125-33-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • desoxyphenobarbital
  • primidone
  • lepimidin
  • primaclone
  • primacone
A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.
  • Molecular weight: 218.26
  • Formula: C12H14N2O2
  • CLOGP: 0.88
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 58.20
  • ALOGS: -2.32
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.25 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.60 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 35 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 98.18 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 92 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.807 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.133 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 10.495 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.550 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 63.530 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 60.600 % High 1
herg hERG pIC50 3.998 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.968 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.170 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 60.490 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PIK3CB,PRKDC 16
kinase-selectivity-class AXL,GRK2,PDK4 3
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.236 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.330 High 1
mh-clint Mouse hepatocyte intrinsic clearance 10.914 High 1
mppb Mouse plasma protein binding (% unbound) 53.680 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.875 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 69.270 % High 1
rat-kpuu-brain Rat brain Kpuu 0.206 % High 1
rh-clint Rat hepatocyte intrinsic clearance 3.945 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 92.270 % High 1
rppb Rat plasma protein binding (% unbound) 50.060 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 926.830 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 8, 1954 FDA VALEANT

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
Seizure 170.13 14.06 136 9498 152493 90466320
Tremor 109.28 14.06 106 9528 153067 90465746
Completed suicide 108.42 14.06 103 9531 144955 90473858
Fall 89.57 14.06 173 9461 481637 90137176
Petit mal epilepsy 68.20 14.06 24 9610 4934 90613879
Ataxia 57.23 14.06 31 9603 18011 90600802
Drug interaction 53.35 14.06 101 9533 276352 90342461
Drug withdrawal convulsions 40.02 14.06 12 9622 1488 90617325
Myoclonic epilepsy 39.06 14.06 12 9622 1615 90617198
Anticonvulsant drug level increased 38.29 14.06 12 9622 1724 90617089
Somnolence 37.37 14.06 74 9560 209010 90409803
Product complaint 36.80 14.06 21 9613 13479 90605334
Essential tremor 36.39 14.06 11 9623 1401 90617412
Lennox-Gastaut syndrome 36.10 14.06 8 9626 297 90618516
Generalised tonic-clonic seizure 30.33 14.06 27 9607 34876 90583937
Cerebellar atrophy 28.37 14.06 8 9626 799 90618014
Balance disorder 27.32 14.06 42 9592 97038 90521775
Diplopia 26.52 14.06 23 9611 28691 90590122
Infusion related reaction 24.46 14.06 7 9627 416773 90202040
Contraindicated product administered 23.80 14.06 3 9631 320136 90298677
Hallucination 23.63 14.06 32 9602 65927 90552886
Systemic lupus erythematosus 23.33 14.06 5 9629 361891 90256922
Urinary tract infection 22.91 14.06 78 9556 305554 90313259
Anticonvulsant drug level above therapeutic 21.65 14.06 6 9628 563 90618250
Multiple sclerosis 21.19 14.06 20 9614 27820 90590993
Toxicity to various agents 21.17 14.06 73 9561 287773 90331040
Hemianopia 20.93 14.06 8 9626 2074 90616739
Joint swelling 20.81 14.06 14 9620 503286 90115527
Product substitution issue 19.90 14.06 16 9618 17992 90600821
Nystagmus 19.05 14.06 11 9623 7216 90611597
Loss of consciousness 18.57 14.06 44 9590 140194 90478619
Multiple-drug resistance 18.30 14.06 11 9623 7765 90611048
Glossodynia 17.80 14.06 6 9628 321773 90297040
Drug ineffective for unapproved indication 17.59 14.06 28 9606 66616 90552197
Dysarthria 17.37 14.06 25 9609 54457 90564356
Status epilepticus 17.19 14.06 15 9619 18859 90599954
Multiple sclerosis relapse 16.68 14.06 24 9610 52281 90566532
Rheumatoid arthritis 16.50 14.06 9 9625 362605 90256208
Abdominal discomfort 16.34 14.06 16 9618 477312 90141501
Product dose omission issue 15.70 14.06 67 9567 291620 90327193
Hyperacusis 15.38 14.06 7 9627 2804 90616009
Drug intolerance 15.32 14.06 15 9619 447576 90171237
Hypokalaemia 15.10 14.06 39 9595 131077 90487736
Dyskinesia 15.06 14.06 19 9615 36515 90582298
Psoriatic arthropathy 15.02 14.06 3 9631 228332 90390481
Gait disturbance 14.92 14.06 61 9573 260435 90358378
Deafness transitory 14.13 14.06 6 9628 2037 90616776
Dizziness 14.13 14.06 109 9525 589175 90029638

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
Ataxia 88.07 17.33 46 6959 16079 42598251
Developmental delay 76.13 17.33 26 6979 3156 42611174
Somnolence 74.22 17.33 103 6902 141002 42473328
Serotonin syndrome 70.36 17.33 47 6958 25798 42588532
Drug interaction 64.63 17.33 138 6867 266861 42347469
Growth hormone-producing pituitary tumour 56.22 17.33 11 6994 138 42614192
Seizure 54.56 17.33 82 6923 120479 42493851
Gastric hypomotility 52.14 17.33 11 6994 205 42614125
Shunt malfunction 49.26 17.33 11 6994 270 42614060
Viral diarrhoea 47.63 17.33 11 6994 315 42614015
Tremor 46.81 17.33 68 6937 96861 42517469
Status epilepticus 46.45 17.33 30 6975 15548 42598782
Hallucination 46.25 17.33 52 6953 57455 42556875
Blood growth hormone increased 40.20 17.33 11 6994 633 42613697
Gingival atrophy 39.97 17.33 7 6998 45 42614285
Multiple-drug resistance 37.44 17.33 20 6985 7302 42607028
Breath odour 35.38 17.33 11 6994 992 42613338
Shunt occlusion 35.12 17.33 11 6994 1016 42613314
Generalised tonic-clonic seizure 34.37 17.33 31 6974 26348 42587982
Infrequent bowel movements 33.79 17.33 11 6994 1151 42613179
Fall 33.20 17.33 99 6906 234421 42379909
Drug ineffective 30.65 17.33 192 6813 630005 41984325
Insulin-like growth factor increased 30.14 17.33 11 6994 1620 42612710
Strabismus 29.64 17.33 12 6993 2336 42611994
Plantar fascial fibromatosis 28.62 17.33 4 7001 3 42614327
Bone metabolism disorder 28.42 17.33 7 6998 265 42614065
Open angle glaucoma 28.37 17.33 7 6998 267 42614063
Cervicobrachial syndrome 27.10 17.33 7 6998 322 42614008
Parkinsonian rest tremor 27.06 17.33 7 6998 324 42614006
Pleocytosis 26.46 17.33 8 6997 657 42613673
Foot deformity 26.35 17.33 14 6991 5054 42609276
Acute kidney injury 26.07 17.33 14 6991 367323 42247007
Completed suicide 25.71 17.33 52 6953 96413 42517917
Cerebellar atrophy 25.43 17.33 8 6997 750 42613580
Helicobacter infection 25.04 17.33 11 6994 2621 42611709
Product use issue 24.92 17.33 45 6960 76706 42537624
Encephalopathy 24.43 17.33 32 6973 41301 42573029
Focal dyscognitive seizures 23.82 17.33 9 6996 1458 42612872
Gingival disorder 23.21 17.33 9 6996 1565 42612765
Lens dislocation 21.93 17.33 5 7000 135 42614195
Eye movement disorder 21.13 17.33 12 6993 4933 42609397
Brain injury 21.00 17.33 14 6991 7641 42606689
Nosocomial infection 20.43 17.33 8 6997 1428 42612902
Nystagmus 20.16 17.33 12 6993 5384 42608946
Obsessive-compulsive disorder 20.13 17.33 13 6992 6730 42607600
Eructation 19.97 17.33 12 6993 5474 42608856
Balance disorder 19.52 17.33 31 6974 47614 42566716
Anticonvulsant drug level above therapeutic 17.73 17.33 6 6999 707 42613623
Jaw disorder 17.38 17.33 8 6997 2125 42612205

FDA Adverse Event Reporting System (Geriatric)

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
Completed suicide 139.19 14.20 157 12932 242224 110333986
Ataxia 133.29 14.20 67 13022 30041 110546169
Seizure 123.10 14.20 141 12948 221044 110355166
Drug interaction 118.54 14.20 212 12877 499971 110076239
Tremor 112.65 14.20 129 12960 202103 110374107
Fall 93.03 14.20 214 12875 603268 109972942
Somnolence 75.38 14.20 130 12959 297319 110278891
Developmental delay 75.15 14.20 20 13069 1445 110574765
Growth hormone-producing pituitary tumour 59.38 14.20 11 13078 144 110576066
Hallucination 53.55 14.20 63 13026 101369 110474841
Gastric hypomotility 51.95 14.20 11 13078 294 110575916
Shunt malfunction 49.84 14.20 11 13078 359 110575851
Serotonin syndrome 49.55 14.20 47 13042 59106 110517104
Petit mal epilepsy 49.40 14.20 22 13067 7525 110568685
Status epilepticus 47.08 14.20 35 13054 31536 110544674
Viral diarrhoea 44.66 14.20 11 13078 583 110575627
Cerebellar atrophy 43.41 14.20 13 13076 1440 110574770
Multiple-drug resistance 43.09 14.20 24 13065 13211 110562999
Generalised tonic-clonic seizure 41.21 14.20 41 13048 54639 110521571
Lennox-Gastaut syndrome 40.53 14.20 9 13080 302 110575908
Gingival atrophy 38.75 14.20 7 13082 79 110576131
Blood growth hormone increased 38.26 14.20 11 13078 1057 110575153
Nystagmus 37.71 14.20 21 13068 11556 110564654
Toxicity to various agents 35.38 14.20 131 12958 480424 110095786
Parkinsonian rest tremor 33.09 14.20 8 13081 392 110575818
Shunt occlusion 32.99 14.20 11 13078 1726 110574484
Anticonvulsant drug level above therapeutic 32.19 14.20 10 13079 1252 110574958
Breath odour 31.51 14.20 11 13078 1981 110574229
Drug ineffective for unapproved indication 31.47 14.20 49 13040 102789 110473421
Infrequent bowel movements 30.57 14.20 11 13078 2164 110574046
Insulin-like growth factor increased 29.99 14.20 11 13078 2285 110573925
Strabismus 28.82 14.20 12 13077 3487 110572723
Essential tremor 28.40 14.20 10 13079 1848 110574362
Myoclonic epilepsy 28.29 14.20 11 13078 2680 110573530
Anticonvulsant drug level increased 27.64 14.20 11 13078 2847 110573363
Balance disorder 25.69 14.20 48 13041 116512 110459698
Open angle glaucoma 25.52 14.20 7 13082 567 110575643
Bone metabolism disorder 25.33 14.20 7 13082 583 110575627
Focal dyscognitive seizures 24.49 14.20 11 13078 3838 110572372
Mental status changes 24.31 14.20 37 13052 76085 110500125
Gingival disorder 23.69 14.20 11 13078 4142 110572068
Anticonvulsant drug level decreased 23.41 14.20 9 13080 2127 110574083
Obsessive-compulsive disorder 23.21 14.20 13 13076 7228 110568982
Plantar fascial fibromatosis 22.67 14.20 4 13085 39 110576171
Choreoathetosis 21.68 14.20 8 13081 1690 110574520
Pleocytosis 21.56 14.20 8 13081 1716 110574494
Anticoagulation drug level below therapeutic 21.51 14.20 8 13081 1726 110574484
Encephalopathy 21.23 14.20 36 13053 81019 110495191
Needle issue 20.58 14.20 17 13072 17823 110558387
Cervicobrachial syndrome 20.47 14.20 7 13082 1185 110575025
Dizziness 20.47 14.20 147 12942 698046 109878164
Dysarthria 20.25 14.20 36 13053 84085 110492125
Infusion related reaction 20.09 14.20 10 13079 381152 110195058
Drug ineffective 19.81 14.20 270 12819 1520270 109055940
Inhibitory drug interaction 18.97 14.20 10 13079 4937 110571273
Dementia 18.95 14.20 21 13068 31652 110544558
Jaw disorder 18.48 14.20 10 13079 5202 110571008
Urinary tract infection 18.44 14.20 82 13007 326200 110250010
Brain injury 18.01 14.20 14 13075 13462 110562748
Hemianopia 17.62 14.20 8 13081 2860 110573350
Joint swelling 17.48 14.20 16 13073 442829 110133381
Contraindicated product administered 17.43 14.20 4 13085 248263 110327947
Eye movement disorder 17.28 14.20 12 13077 9716 110566494
Psychomotor retardation 17.19 14.20 11 13078 7781 110568429
Oesophageal ulcer 16.97 14.20 11 13078 7953 110568257
Lower respiratory tract infection 16.90 14.20 4 13085 243102 110333108
Acute kidney injury 16.81 14.20 31 13058 635399 109940811
Nosocomial infection 16.79 14.20 8 13081 3191 110573019
Lens dislocation 16.73 14.20 4 13085 187 110576023
Injection site haemorrhage 16.57 14.20 20 13069 33008 110543202
Loss of consciousness 16.54 14.20 56 13033 196250 110379960
Maternal exposure during pregnancy 16.21 14.20 5 13084 254878 110321332
Overdose 15.73 14.20 62 13027 233732 110342478
Febrile neutropenia 15.68 14.20 9 13080 316758 110259452
Altered state of consciousness 15.63 14.20 26 13063 57600 110518610
Death 15.47 14.20 138 12951 698731 109877479
Psychotic symptom 15.35 14.20 8 13081 3859 110572351
Multiple sclerosis 15.30 14.20 17 13072 25681 110550529
Gait disturbance 15.02 14.20 69 13020 278139 110298071
Anticoagulation drug level decreased 15.01 14.20 4 13085 290 110575920
Glossodynia 14.77 14.20 4 13085 222000 110354210
Upper limb fracture 14.52 14.20 15 13074 20873 110555337
Systemic lupus erythematosus 14.45 14.20 6 13083 254332 110321878
Stomatitis 14.37 14.20 7 13082 270235 110305975
Electroencephalogram abnormal 14.33 14.20 9 13080 6164 110570046
International normalised ratio decreased 14.26 14.20 10 13079 8226 110567984

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AA03 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Barbiturates and derivatives
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
FDA EPC N0000175753 Anti-epileptic Agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

N03AA Barbiturates and derivatives 4 drugs

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

DiseaseRelationSNOMED_IDDOID
Tonic-clonic seizure indication 54200006
Epilepsy indication 84757009 DOID:1826
Bipolar disorder in remission indication 85248005
Localization-related epilepsy indication 230381009 DOID:2234
Lennox-Gastaut syndrome indication 230418006
Tonic-clonic epilepsy indication 352818000 DOID:7725
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Neuropathic pain off-label use 247398009
Essential tremor off-label use 609558009 DOID:4990
Rapid Cycling Bipolar Affective Disorder off-label use
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Constitutional aplastic anemia contraindication 28975000 DOID:1342
Depressive disorder contraindication 35489007
Megaloblastic anemia contraindication 53165003 DOID:13382
Acute nephropathy contraindication 58574008
Sleep apnea contraindication 73430006 DOID:0050847
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Pancytopenia contraindication 127034005 DOID:12450
Non-infective meningitis contraindication 230155003
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Granulocytopenic disorder contraindication 417672002
Porphyria contraindication 418470004
Primidone Toxicity contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Convulsions associated with idiopathic epilepsy Indication
Dogs Epileptiform convulsions Indication
Dogs Viral encephalitis Indication
Dogs Distemper Indication
Dogs Hardpad disease Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Primidone Zoetis Inc. 1
Mylepsin Tablets Zoetis Inc. 1
Mylepsin, Primidone Medi-Pets Zoetis Inc. 1
Neurosyn Tablets Cronus Pharma Specialities India Private Limited 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.99 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR WOMBAT-PK CHEMBL
Transient receptor potential cation channel subfamily M member 3 Ion channel BLOCKER IC50 6.20 IUPHAR

External reference:

IDSource
4018485 VUID
N0000146807 NUI
D00474 KEGG_DRUG
4018485 VANDF
C0033148 UMLSCUI
CHEBI:8412 CHEBI
A1AIA PDB_CHEM_ID
CHEMBL856 ChEMBL_ID
DB00794 DRUGBANK_ID
D011324 MESH_DESCRIPTOR_UI
4909 PUBCHEM_CID
5338 IUPHAR_LIGAND_ID
248 INN_ID
13AFD7670Q UNII
8691 RXNORM
390 MMSL
5355 MMSL
d00352 MMSL
001626 NDDF
387256009 SNOMEDCT_US
47120002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 0527-1231 TABLET 250 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 0527-1301 TABLET 50 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 0591-5321 TABLET 250 mg ORAL ANDA 13 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8206 TABLET 50 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 10135-522 TABLET 250 mg ORAL ANDA 15 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 10135-540 TABLET 50 mg ORAL ANDA 15 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 42291-509 TABLET 50 mg ORAL ANDA 16 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 42291-511 TABLET 250 mg ORAL ANDA 16 sections
PRIMIDONE HUMAN PRESCRIPTION DRUG LABEL 1 42549-680 TABLET 50 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 50090-1622 TABLET 250 mg ORAL ANDA 13 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 50268-686 TABLET 50 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 50268-686 TABLET 50 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 50268-687 TABLET 250 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 50268-687 TABLET 250 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 51407-637 TABLET 50 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 51407-638 TABLET 250 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 52817-117 TABLET 125 mg ORAL ANDA 15 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 53746-544 TABLET 50 mg ORAL ANDA 12 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 53746-545 TABLET 250 mg ORAL ANDA 12 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 54868-1691 TABLET 250 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 54868-5067 TABLET 50 mg ORAL ANDA 14 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 55111-476 TABLET 250 mg ORAL ANDA 13 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 55111-477 TABLET 50 mg ORAL ANDA 13 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 62135-468 TABLET 50 mg ORAL ANDA 11 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 63629-7811 TABLET 50 mg ORAL ANDA 12 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 65162-544 TABLET 50 mg ORAL ANDA 12 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 65162-545 TABLET 250 mg ORAL ANDA 12 sections
Mysoline HUMAN PRESCRIPTION DRUG LABEL 1 66490-690 TABLET 50 mg ORAL NDA 15 sections
Mysoline HUMAN PRESCRIPTION DRUG LABEL 1 66490-691 TABLET 250 mg ORAL NDA 15 sections
Primidone HUMAN PRESCRIPTION DRUG LABEL 1 68084-202 TABLET 50 mg ORAL ANDA 15 sections