triazolam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
diazepam derivatives 2729 28911-01-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • triazolam
  • U-33,030
  • U 33,030
  • U33,030
A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries.
  • Molecular weight: 343.21
  • Formula: C17H12Cl2N4
  • CLOGP: 2.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 43.07
  • ALOGS: -4.27
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.25 mg O
0.20 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.05 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.02 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 44 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.70 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.473 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.698 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 65.464 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 22.646 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 15.760 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 39.290 % High 1
herg hERG pIC50 4.698 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 5.675 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 41.976 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 17.280 % High 1
kinase-safety-class ACVR2B,AXL,EIF2AK3,GRK2,ITK,MAPK10,MAPK7,PDK4,PIK3CG 9
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.159 High 1
mh-clint Mouse hepatocyte intrinsic clearance 38.637 High 1
mppb Mouse plasma protein binding (% unbound) 19.200 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 9.886 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 24.960 % High 1
rh-clint Rat hepatocyte intrinsic clearance 131.522 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 67.330 % High 1
rppb Rat plasma protein binding (% unbound) 19.310 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 197.242 uM High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 15, 1982 FDA PHARMACIA AND UPJOHN

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
Sopor 840.91 19.07 225 7201 24419 90596602
Drug abuse 634.82 19.07 242 7184 82105 90538916
Intentional self-injury 238.98 19.07 90 7336 29244 90591777
Overdose 152.22 19.07 116 7310 157593 90463428
Intentional overdose 144.52 19.07 92 7334 93742 90527279
Suicide attempt 141.81 19.07 84 7342 75315 90545706
Loss of consciousness 94.94 19.07 84 7342 140154 90480867
Completed suicide 90.54 19.07 83 7343 144975 90476046
Toxicity to various agents 86.60 19.07 112 7314 287734 90333287
Hemianopia 85.11 19.07 22 7404 2060 90618961
Coma 84.79 19.07 60 7366 72572 90548449
Alcohol interaction 54.88 19.07 15 7411 1739 90619282
Drug interaction 53.00 19.07 87 7339 276366 90344655
Corneal epithelium defect 50.77 19.07 11 7415 480 90620541
Anterior chamber cell 46.34 19.07 11 7415 725 90620296
Punctate keratitis 45.48 19.07 11 7415 785 90620236
Syncope 40.38 19.07 52 7374 132611 90488410
Torsade de pointes 39.62 19.07 21 7405 15161 90605860
Purpura senile 37.72 19.07 9 7417 606 90620415
Bradyphrenia 36.55 19.07 16 7410 7596 90613425
Hypokinesia 36.19 19.07 20 7406 15677 90605344
Corneal oedema 35.99 19.07 11 7415 1890 90619131
Altered state of consciousness 34.36 19.07 25 7401 31507 90589514
Hepatic function abnormal 33.83 19.07 29 7397 46259 90574762
Tarsal tunnel syndrome 33.10 19.07 8 7418 569 90620452
Application site injury 32.93 19.07 5 7421 26 90620995
Hyponatraemic encephalopathy 32.45 19.07 7 7419 299 90620722
Somnolence 31.21 19.07 59 7367 209025 90411996
Joint swelling 30.48 19.07 3 7423 503297 90117724
Hyporesponsive to stimuli 29.10 19.07 9 7417 1608 90619413
Bradykinesia 28.54 19.07 13 7413 6775 90614246
Electrocardiogram QT prolonged 27.89 19.07 32 7394 72424 90548597
Application site ulcer 27.28 19.07 5 7421 91 90620930
Resorption bone increased 27.17 19.07 8 7418 1211 90619810
Drug dependence 26.95 19.07 21 7405 29306 90591715
Vestibular disorder 25.28 19.07 8 7418 1541 90619480
Blood creatine phosphokinase increased 24.22 19.07 21 7405 34002 90587019
Intentional product misuse 23.98 19.07 33 7393 89571 90531450
Cerebral haemorrhage 23.95 19.07 21 7405 34501 90586520
Drug intolerance 23.88 19.07 4 7422 447587 90173434
Skin fissures 23.81 19.07 17 7409 20792 90600229
Postoperative delirium 23.24 19.07 5 7421 211 90620810
Intellectual disability 22.48 19.07 7 7419 1279 90619742
Labelled drug-drug interaction issue 22.32 19.07 8 7418 2250 90618771
Hypersensitivity 22.28 19.07 5 7421 454672 90166349
Hallucination, visual 22.23 19.07 17 7409 23075 90597946
Electrocardiogram T wave inversion 21.86 19.07 9 7417 3674 90617347
Depressed level of consciousness 21.30 19.07 28 7398 72756 90548265
Neuroleptic malignant syndrome 21.22 19.07 14 7412 15082 90605939
Extrasystoles 21.18 19.07 10 7416 5647 90615374
Poisoning 21.12 19.07 14 7412 15203 90605818
Attention deficit hyperactivity disorder 20.76 19.07 9 7417 4175 90616846
Serotonin syndrome 20.38 19.07 20 7406 37867 90583154
Arthropathy 20.15 19.07 3 7423 366239 90254782
Hypoglycaemic coma 20.14 19.07 8 7418 2982 90618039
Swelling 19.76 19.07 5 7421 419053 90201968
Hyperventilation 19.54 19.07 10 7416 6718 90614303
Peripheral swelling 19.34 19.07 5 7421 413101 90207920
Dysarthria 19.19 19.07 23 7403 54459 90566562

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
Sopor 408.58 19.72 121 4911 13081 42603222
Drug abuse 256.41 19.72 157 4875 104614 42511689
Intentional overdose 95.49 19.72 65 4967 51391 42564912
Bradyphrenia 64.37 19.72 24 5008 5238 42611065
Alcohol interaction 63.42 19.72 19 5013 2116 42614187
Completed suicide 54.70 19.72 62 4970 96403 42519900
Drug dependence 54.49 19.72 37 4995 29057 42587246
Overdose 53.59 19.72 64 4968 105200 42511103
Suicide attempt 53.55 19.72 44 4988 46056 42570247
Intentional self-injury 50.79 19.72 28 5004 15174 42601129
Reduced facial expression 47.08 19.72 14 5018 1519 42614784
Toxicity to various agents 44.42 19.72 89 4943 229047 42387256
Dissociative disorder 43.34 19.72 11 5021 661 42615642
Depressed level of consciousness 42.03 19.72 39 4993 47931 42568372
Suicidal ideation 36.22 19.72 36 4996 48125 42568178
Hypokinesia 32.47 19.72 18 5014 9853 42606450
Altered state of consciousness 32.03 19.72 27 5005 29232 42587071
Eye haematoma 29.18 19.72 6 5026 139 42616164
Blood creatine phosphokinase increased 28.95 19.72 32 5000 48306 42567997
Somnolence 25.13 19.72 53 4979 141052 42475251
Dissociation 24.66 19.72 11 5021 3787 42612516
Loss of consciousness 24.30 19.72 41 4991 92313 42523990
Hypertensive crisis 24.05 19.72 15 5017 10191 42606112
Neuroleptic malignant syndrome 23.88 19.72 20 5012 21452 42594851
Mental impairment 23.85 19.72 16 5016 12301 42604002
Drug interaction 23.50 19.72 77 4955 266922 42349381
Thinking abnormal 23.39 19.72 13 5019 7148 42609155
Road traffic accident 21.68 19.72 18 5014 19075 42597228
Fear 20.64 19.72 14 5018 10951 42605352
Panic attack 20.55 19.72 14 5018 11031 42605272
Mental disorder 20.47 19.72 17 5015 18012 42598291

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
Sopor 1167.30 17.67 335 11400 36211 110541353
Drug abuse 816.83 17.67 390 11345 177021 110400543
Intentional self-injury 276.56 17.67 115 11620 37314 110540250
Intentional overdose 219.95 17.67 150 11585 132351 110445213
Suicide attempt 183.36 17.67 122 11613 103272 110474292
Overdose 180.96 17.67 169 11566 233625 110343939
Completed suicide 130.37 17.67 144 11591 242237 110335327
Toxicity to various agents 117.09 17.67 194 11541 480361 110097203
Alcohol interaction 109.31 17.67 32 11703 3662 110573902
Loss of consciousness 106.14 17.67 117 11618 196189 110381375
Bradyphrenia 86.43 17.67 36 11699 11692 110565872
Drug dependence 74.36 17.67 53 11682 49967 110527597
Hemianopia 68.24 17.67 21 11714 2847 110574717
Drug interaction 66.81 17.67 157 11578 500026 110077538
Hypokinesia 62.40 17.67 35 11700 21791 110555773
Coma 59.78 17.67 68 11667 117801 110459763
Depressed level of consciousness 59.03 17.67 66 11669 112212 110465352
Somnolence 56.67 17.67 108 11627 297341 110280223
Corneal epithelium defect 55.75 17.67 14 11721 898 110576666
Altered state of consciousness 55.04 17.67 47 11688 57579 110519985
Punctate keratitis 51.89 17.67 14 11721 1190 110576374
Anterior chamber cell 51.70 17.67 14 11721 1207 110576357
Hyporesponsive to stimuli 47.75 17.67 16 11719 2844 110574720
Blood creatine phosphokinase increased 47.32 17.67 48 11687 73029 110504535
Hepatic function abnormal 44.39 17.67 51 11684 89244 110488320
Neuroleptic malignant syndrome 43.64 17.67 33 11702 34026 110543538
Dissociative disorder 42.19 17.67 12 11723 1239 110576325
Reduced facial expression 40.24 17.67 15 11720 3636 110573928
Corneal oedema 38.53 17.67 14 11721 3159 110574405
Electrocardiogram QT prolonged 36.32 17.67 51 11684 108909 110468655
Mental impairment 35.99 17.67 25 11710 22614 110554950
Joint swelling 35.82 17.67 3 11732 442842 110134722
Intentional product misuse 34.03 17.67 55 11680 132849 110444715
Torsade de pointes 33.70 17.67 24 11711 22576 110554988
Suicidal ideation 32.85 17.67 45 11690 93892 110483672
Application site injury 31.80 17.67 5 11730 25 110577539
Tarsal tunnel syndrome 31.44 17.67 8 11727 541 110577023
Confusional state 31.32 17.67 115 11620 468565 110108999
Purpura senile 30.54 17.67 8 11727 607 110576957
Hyponatraemic encephalopathy 28.82 17.67 7 11728 391 110577173
Vestibular disorder 26.06 17.67 10 11725 2622 110574942
Fall 25.56 17.67 129 11606 603353 109974211
Eye haematoma 25.47 17.67 6 11729 294 110577270
Hypersensitivity 25.13 17.67 6 11729 403992 110173572
Bradykinesia 24.75 17.67 15 11720 10773 110566791
Application site ulcer 24.64 17.67 5 11730 121 110577443
Heat illness 24.04 17.67 7 11728 785 110576779
Hypertensive crisis 23.51 17.67 20 11715 24352 110553212
Drug intolerance 23.46 17.67 7 11728 406505 110171059
Resorption bone increased 23.32 17.67 8 11727 1526 110576038
Rhabdomyolysis 23.23 17.67 44 11691 120357 110457207
Miosis 23.20 17.67 19 11716 21964 110555600
Dysarthria 23.16 17.67 36 11699 84085 110493479
Syncope 23.16 17.67 60 11675 202476 110375088
Rheumatoid arthritis 21.75 17.67 3 11732 299610 110277954
Peripheral swelling 21.50 17.67 8 11727 404026 110173538
Cerebral infarction 21.48 17.67 27 11708 51811 110525753
Fatigue 21.05 17.67 63 11672 1215895 109361669
Interstitial lung disease 21.04 17.67 46 11689 139288 110438276
Swelling 20.34 17.67 6 11729 351035 110226529
Drug ineffective 20.23 17.67 88 11647 1520452 109057112
Urinary incontinence 19.64 17.67 25 11710 48562 110529002
Activation syndrome 19.14 17.67 5 11730 375 110577189
Hypoglycaemic coma 18.94 17.67 10 11725 5523 110572041
Panic attack 18.71 17.67 19 11716 28921 110548643
Delirium 18.62 17.67 43 11692 134982 110442582
Off label use 18.07 17.67 90 11645 1500095 109077469
Attention deficit hyperactivity disorder 17.93 17.67 9 11726 4482 110573082
Intellectual disability 17.76 17.67 7 11728 1972 110575592
Disturbance in attention 17.72 17.67 27 11708 61968 110515596

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CD05 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
FDA EPC N0000175694 Benzodiazepine
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35717 sedative

Related Drugs by ATC class:

N05CD Benzodiazepine derivatives 14 drugs
brotizolamcinolazepamdoxefazepamestazolamflunitrazepamflurazepamloprazolamlormetazepammidazolamnimetazepamnitrazepamquazepam show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Insomnia indication 193462001
Suicidal thoughts contraindication 6471006
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Hypoalbuminemia contraindication 119247004
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.22 Basic
pKa2 4.62 Basic

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-5/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.70 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.88 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.11 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-3/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.70 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.22 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.16 WOMBAT-PK CHEMBL
GABA-A receptor alpha-2/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.23 WOMBAT-PK CHEMBL
GABA-A receptor alpha-3/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.85 WOMBAT-PK CHEMBL
GABA-A receptor alpha-5/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.02 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.64 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.10 WOMBAT-PK CHEMBL
GABA-A receptor Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.10 IUPHAR CHEMBL
Platelet-activating factor receptor GPCR Ki 5.88 PDSP
Cytochrome P450 3A4 Enzyme Ki 4.27 WOMBAT-PK
Cholecystokinin receptor type A GPCR IC50 4.41 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 9.10 CHEMBL

External reference:

IDSource
4018066 VUID
N0000146407 NUI
D00387 KEGG_DRUG
4018066 VANDF
C0040879 UMLSCUI
CHEMBL646 ChEMBL_ID
DB00897 DRUGBANK_ID
D014229 MESH_DESCRIPTOR_UI
5556 PUBCHEM_CID
7313 IUPHAR_LIGAND_ID
3409 INN_ID
1HM943223R UNII
10767 RXNORM
3103 MMSL
5618 MMSL
d00397 MMSL
001466 NDDF
111128007 SNOMEDCT_US
386984001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TRIAZOLAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-236 TABLET 0.25 mg ORAL NDA authorized generic 28 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 21695-284 TABLET 0.25 mg ORAL ANDA 22 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 21695-303 TABLET 0.13 mg ORAL ANDA 22 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 43353-451 TABLET 0.25 mg ORAL NDA AUTHORIZED GENERIC 29 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50090-0522 TABLET 0.25 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50090-6471 TABLET 0.25 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50090-7787 TABLET 0.25 mg ORAL ANDA 29 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50436-3718 TABLET 0.25 mg ORAL NDA AUTHORIZED GENERIC 28 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50742-645 TABLET 0.13 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 50742-646 TABLET 0.25 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 59762-3717 TABLET 0.13 mg ORAL NDA authorized generic 32 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 59762-3718 TABLET 0.25 mg ORAL NDA authorized generic 32 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 67544-725 TABLET 0.25 mg ORAL ANDA 23 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 70710-1289 TABLET 0.25 mg ORAL ANDA 29 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 70710-1521 TABLET 0.13 mg ORAL ANDA 29 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 70771-1162 TABLET 0.25 mg ORAL ANDA 2 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 70771-1576 TABLET 0.13 mg ORAL ANDA 2 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 71335-1876 TABLET 0.25 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 72789-349 TABLET 0.25 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 72789-349 TABLET 0.25 mg ORAL ANDA 30 sections
Triazolam HUMAN PRESCRIPTION DRUG LABEL 1 82804-275 TABLET 0.25 mg ORAL ANDA 30 sections