primidone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2267 | 125-33-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.25 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 92 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 8, 1954 | FDA | VALEANT |
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 |
|---|---|---|---|---|---|---|
| Seizure | 149.84 | 14.21 | 129 | 8035 | 132505 | 63348353 |
| Tremor | 73.97 | 14.21 | 88 | 8076 | 132151 | 63348707 |
| Petit mal epilepsy | 66.14 | 14.21 | 23 | 8141 | 3771 | 63477087 |
| Fall | 65.62 | 14.21 | 151 | 8013 | 392183 | 63088675 |
| Ataxia | 51.23 | 14.21 | 29 | 8135 | 15166 | 63465692 |
| Completed suicide | 49.37 | 14.21 | 76 | 8088 | 145597 | 63335261 |
| Drug interaction | 41.32 | 14.21 | 91 | 8073 | 229040 | 63251818 |
| Anticonvulsant drug level increased | 37.64 | 14.21 | 12 | 8152 | 1505 | 63479353 |
| Lennox-Gastaut syndrome | 35.35 | 14.21 | 8 | 8156 | 269 | 63480589 |
| Product complaint | 34.13 | 14.21 | 21 | 8143 | 12788 | 63468070 |
| Myoclonic epilepsy | 31.44 | 14.21 | 10 | 8154 | 1244 | 63479614 |
| Cerebellar atrophy | 27.47 | 14.21 | 8 | 8156 | 740 | 63480118 |
| Generalised tonic-clonic seizure | 26.31 | 14.21 | 25 | 8139 | 28991 | 63451867 |
| Somnolence | 24.64 | 14.21 | 64 | 8100 | 178621 | 63302237 |
| Diplopia | 24.54 | 14.21 | 22 | 8142 | 23706 | 63457152 |
| Essential tremor | 24.51 | 14.21 | 8 | 8156 | 1080 | 63479778 |
| Anticonvulsant drug level above therapeutic | 20.92 | 14.21 | 6 | 8158 | 526 | 63480332 |
| Balance disorder | 20.51 | 14.21 | 38 | 8126 | 84384 | 63396474 |
| Nystagmus | 18.64 | 14.21 | 11 | 8153 | 6209 | 63474649 |
| Epilepsy | 18.47 | 14.21 | 20 | 8144 | 27045 | 63453813 |
| Dysarthria | 18.40 | 14.21 | 25 | 8139 | 42686 | 63438172 |
| Urinary tract infection | 18.40 | 14.21 | 75 | 8089 | 264609 | 63216249 |
| Loss of consciousness | 16.98 | 14.21 | 43 | 8121 | 118078 | 63362780 |
| Product substitution issue | 16.87 | 14.21 | 15 | 8149 | 15981 | 63464877 |
| Multiple sclerosis | 16.61 | 14.21 | 18 | 8146 | 24354 | 63456504 |
| Gait disturbance | 16.12 | 14.21 | 56 | 8108 | 183122 | 63297736 |
| Hyperacusis | 16.02 | 14.21 | 7 | 8157 | 2106 | 63478752 |
| Status epilepticus | 15.50 | 14.21 | 14 | 8150 | 15219 | 63465639 |
| Joint swelling | 15.12 | 14.21 | 12 | 8152 | 327654 | 63153204 |
| Drug withdrawal convulsions | 15.12 | 14.21 | 6 | 8158 | 1419 | 63479439 |
| Hallucination | 15.01 | 14.21 | 26 | 8138 | 54791 | 63426067 |
| Rheumatoid arthritis | 14.90 | 14.21 | 7 | 8157 | 253812 | 63227046 |
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 |
|---|---|---|---|---|---|---|
| Somnolence | 69.26 | 16.71 | 88 | 5642 | 111028 | 34840173 |
| Ataxia | 65.85 | 16.71 | 36 | 5694 | 13817 | 34937384 |
| Serotonin syndrome | 58.61 | 16.71 | 38 | 5692 | 19895 | 34931306 |
| Seizure | 48.59 | 16.71 | 72 | 5658 | 104785 | 34846416 |
| Drug interaction | 46.15 | 16.71 | 109 | 5621 | 225837 | 34725364 |
| Developmental delay | 41.44 | 16.71 | 16 | 5714 | 2759 | 34948442 |
| Multiple-drug resistance | 40.73 | 16.71 | 19 | 5711 | 5220 | 34945981 |
| Hallucination | 40.56 | 16.71 | 46 | 5684 | 51452 | 34899749 |
| Gingival atrophy | 39.86 | 16.71 | 7 | 5723 | 46 | 34951155 |
| Tremor | 35.79 | 16.71 | 55 | 5675 | 82532 | 34868669 |
| Open angle glaucoma | 31.97 | 16.71 | 7 | 5723 | 157 | 34951044 |
| Fall | 31.15 | 16.71 | 88 | 5642 | 202797 | 34748404 |
| Bone metabolism disorder | 29.09 | 16.71 | 7 | 5723 | 241 | 34950960 |
| Plantar fascial fibromatosis | 28.63 | 16.71 | 4 | 5726 | 3 | 34951198 |
| Drug ineffective | 28.20 | 16.71 | 148 | 5582 | 456603 | 34494598 |
| Cervicobrachial syndrome | 27.21 | 16.71 | 7 | 5723 | 318 | 34950883 |
| Status epilepticus | 25.24 | 16.71 | 19 | 5711 | 12595 | 34938606 |
| Generalised tonic-clonic seizure | 24 | 16.71 | 23 | 5707 | 21151 | 34930050 |
| Gingival disorder | 23.73 | 16.71 | 9 | 5721 | 1478 | 34949723 |
| Lens dislocation | 23.06 | 16.71 | 5 | 5725 | 107 | 34951094 |
| Gastric hypomotility | 23.01 | 16.71 | 5 | 5725 | 108 | 34951093 |
| Nystagmus | 21.70 | 16.71 | 12 | 5718 | 4703 | 34946498 |
| Acute kidney injury | 21.00 | 16.71 | 12 | 5718 | 304976 | 34646225 |
| Focal dyscognitive seizures | 20.75 | 16.71 | 8 | 5722 | 1373 | 34949828 |
| Viral diarrhoea | 20.64 | 16.71 | 5 | 5725 | 177 | 34951024 |
| Balance disorder | 20.36 | 16.71 | 29 | 5701 | 40625 | 34910576 |
| Shunt malfunction | 20.32 | 16.71 | 5 | 5725 | 189 | 34951012 |
| Growth hormone-producing pituitary tumour | 19.85 | 16.71 | 4 | 5726 | 59 | 34951142 |
| Cerebellar atrophy | 19.24 | 16.71 | 6 | 5724 | 548 | 34950653 |
| Overdose | 18.57 | 16.71 | 44 | 5686 | 91015 | 34860186 |
| Anticonvulsant drug level above therapeutic | 18.01 | 16.71 | 6 | 5724 | 676 | 34950525 |
| Completed suicide | 17.44 | 16.71 | 45 | 5685 | 98123 | 34853078 |
| Jaw disorder | 17.25 | 16.71 | 8 | 5722 | 2167 | 34949034 |
| Blood growth hormone increased | 16.89 | 16.71 | 5 | 5725 | 383 | 34950818 |
| Visual field defect | 16.85 | 16.71 | 10 | 5720 | 4473 | 34946728 |
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 |
|---|---|---|---|---|---|---|
| Ataxia | 107.70 | 14.41 | 57 | 10677 | 24982 | 79708672 |
| Seizure | 99.99 | 14.41 | 125 | 10609 | 188709 | 79544945 |
| Drug interaction | 83.63 | 14.41 | 177 | 10557 | 415006 | 79318648 |
| Tremor | 78.13 | 14.41 | 105 | 10629 | 169978 | 79563676 |
| Fall | 77.24 | 14.41 | 189 | 10545 | 487440 | 79246214 |
| Completed suicide | 71.99 | 14.41 | 123 | 10611 | 245644 | 79488010 |
| Somnolence | 51.63 | 14.41 | 105 | 10629 | 238876 | 79494778 |
| Petit mal epilepsy | 49.19 | 14.41 | 21 | 10713 | 5706 | 79727948 |
| Lennox-Gastaut syndrome | 42.40 | 14.41 | 9 | 10725 | 213 | 79733441 |
| Nystagmus | 38.25 | 14.41 | 21 | 10713 | 9883 | 79723771 |
| Gingival atrophy | 38.01 | 14.41 | 7 | 10727 | 77 | 79733577 |
| Serotonin syndrome | 37.87 | 14.41 | 38 | 10696 | 44989 | 79688665 |
| Hallucination | 36.39 | 14.41 | 51 | 10683 | 85694 | 79647960 |
| Cerebellar atrophy | 35.96 | 14.41 | 11 | 10723 | 1150 | 79732504 |
| Developmental delay | 35.32 | 14.41 | 11 | 10723 | 1220 | 79732434 |
| Generalised tonic-clonic seizure | 35.00 | 14.41 | 36 | 10698 | 43874 | 79689780 |
| Anticonvulsant drug level above therapeutic | 31.66 | 14.41 | 10 | 10724 | 1161 | 79732493 |
| Myoclonic epilepsy | 30.25 | 14.41 | 11 | 10723 | 1959 | 79731695 |
| Epilepsy | 29.89 | 14.41 | 32 | 10702 | 40828 | 79692826 |
| Status epilepticus | 28.49 | 14.41 | 25 | 10709 | 25016 | 79708638 |
| Toxicity to various agents | 27.57 | 14.41 | 121 | 10613 | 421419 | 79312235 |
| Anticonvulsant drug level increased | 27.07 | 14.41 | 11 | 10723 | 2642 | 79731012 |
| Multiple-drug resistance | 26.83 | 14.41 | 16 | 10718 | 8792 | 79724862 |
| Open angle glaucoma | 26.36 | 14.41 | 7 | 10727 | 440 | 79733214 |
| Bone metabolism disorder | 25.34 | 14.41 | 7 | 10727 | 511 | 79733143 |
| Mental status changes | 24.30 | 14.41 | 37 | 10697 | 66922 | 79666732 |
| Gingival disorder | 23.69 | 14.41 | 11 | 10723 | 3640 | 79730014 |
| Anticonvulsant drug level decreased | 23.15 | 14.41 | 9 | 10725 | 1925 | 79731729 |
| Plantar fascial fibromatosis | 22.55 | 14.41 | 4 | 10730 | 35 | 79733619 |
| Gastric hypomotility | 21.35 | 14.41 | 5 | 10729 | 187 | 79733467 |
| Choreoathetosis | 21.28 | 14.41 | 8 | 10726 | 1562 | 79732092 |
| Dysarthria | 21.27 | 14.41 | 35 | 10699 | 67587 | 79666067 |
| Focal dyscognitive seizures | 21.00 | 14.41 | 10 | 10724 | 3502 | 79730152 |
| Balance disorder | 20.78 | 14.41 | 43 | 10691 | 98814 | 79634840 |
| Growth hormone-producing pituitary tumour | 20.27 | 14.41 | 4 | 10730 | 65 | 79733589 |
| Cervicobrachial syndrome | 19.86 | 14.41 | 7 | 10727 | 1139 | 79732515 |
| Shunt malfunction | 19.64 | 14.41 | 5 | 10729 | 266 | 79733388 |
| Dementia | 19.25 | 14.41 | 20 | 10714 | 24639 | 79709015 |
| Inhibitory drug interaction | 18.75 | 14.41 | 10 | 10724 | 4443 | 79729211 |
| Urinary tract infection | 18.06 | 14.41 | 79 | 10655 | 274433 | 79459221 |
| Viral diarrhoea | 17.85 | 14.41 | 5 | 10729 | 384 | 79733270 |
| Essential tremor | 17.78 | 14.41 | 7 | 10727 | 1548 | 79732106 |
| Confusional state | 17.60 | 14.41 | 87 | 10647 | 317910 | 79415744 |
| Acute kidney injury | 17.31 | 14.41 | 27 | 10707 | 519377 | 79214277 |
| Oesophageal ulcer | 17.01 | 14.41 | 11 | 10723 | 6964 | 79726690 |
| Overdose | 17.00 | 14.41 | 59 | 10675 | 184147 | 79549507 |
| Lens dislocation | 16.92 | 14.41 | 4 | 10730 | 156 | 79733498 |
| Multiple sclerosis | 15.50 | 14.41 | 17 | 10717 | 22265 | 79711389 |
| Jaw disorder | 15.01 | 14.41 | 9 | 10725 | 4997 | 79728657 |
| Upper limb fracture | 14.80 | 14.41 | 15 | 10719 | 17952 | 79715702 |
| Dizziness | 14.72 | 14.41 | 121 | 10613 | 526320 | 79207334 |
| Blood growth hormone increased | 14.71 | 14.41 | 5 | 10729 | 731 | 79732923 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | D002491 | Central Nervous System Agents |
| MeSH PA | D018682 | GABA Agents |
| MeSH PA | D018757 | GABA Modulators |
| MeSH PA | D018377 | Neurotransmitter Agents |
| CHEBI has role | CHEBI:35623 | anticonvulsants |
| CHEBI has role | CHEBI:35703 | Xenobiotic |
| CHEBI has role | CHEBI:78298 | environmental contaminants |
| FDA EPC | N0000175753 | Anti-epileptic Agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Dogs | Convulsions associated with idiopathic epilepsy | Indication |
| Dogs | Epileptiform convulsions | Indication |
| Dogs | Viral encephalitis | Indication |
| Dogs | Distemper | Indication |
| Dogs | Hardpad disease | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.99 | 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]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 4018485 | VUID |
| N0000146807 | NUI |
| D00474 | KEGG_DRUG |
| 4018485 | VANDF |
| C0033148 | UMLSCUI |
| CHEBI:8412 | CHEBI |
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Primidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1231 | TABLET | 250 mg | ORAL | ANDA | 14 sections |
| 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 | 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 | 0615-8206 | TABLET | 50 mg | ORAL | ANDA | 11 sections |
| Primidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-5559 | TABLET | 50 mg | ORAL | ANDA | 14 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 | 42291-509 | 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 | 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 | 50090-4083 | TABLET | 250 mg | ORAL | ANDA | 12 sections |
| Primidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4083 | TABLET | 250 mg | ORAL | ANDA | 12 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 | 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 | 53746-544 | 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 | 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 |