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

Stem definitionDrug idCAS RN
antihyperglycaemics 1314 10238-21-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • glyburide
  • glibenclamide
  • glicuformine
An antidiabetic sulfonylurea derivative with actions similar to those of chlorpropamide.
  • Molecular weight: 494
  • Formula: C23H28ClN3O5S
  • CLOGP: 4.24
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 113.60
  • ALOGS: -5.38
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
7 mg O
10 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) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.58 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 82 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.08 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.82 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) 2.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 1, 1984 FDA SANOFI AVENTIS US

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
Hypoglycaemia 810.71 10.99 433 23285 58580 53266768
Blood glucose increased 334.41 10.99 276 23442 77085 53248263
Lactic acidosis 165.11 10.99 135 23583 37118 53288230
Blood glucose decreased 129.61 10.99 91 23627 19925 53305423
Cardiac failure congestive 119.57 10.99 175 23543 92582 53232766
Coronary artery disease 119.24 10.99 107 23611 33330 53292018
Myocardial infarction 113.24 10.99 177 23541 99177 53226171
Diabetes mellitus inadequate control 109.15 10.99 72 23646 14238 53311110
Glycosylated haemoglobin increased 84.92 10.99 57 23661 11598 53313750
Hyperglycaemia 80.26 10.99 94 23624 39990 53285358
Hypoglycaemic coma 74.76 10.99 32 23686 2626 53322722
Off label use 60.22 10.99 73 23645 472139 52853209
Hypertensive emergency 59.48 10.99 24 23694 1697 53323651
Rheumatoid arthritis 42.88 10.99 46 23672 314485 53010863
Blood glucose fluctuation 42.42 10.99 26 23692 4525 53320823
Hyperkalaemia 38.91 10.99 79 23639 54177 53271171
Diabetes mellitus 38.08 10.99 78 23640 53821 53271527
Alopecia 37.03 10.99 30 23688 234553 53090795
Contraindicated product administered 36.20 10.99 8 23710 135621 53189727
Acute kidney injury 34.09 10.99 211 23507 253657 53071691
Pancreatitis 34.05 10.99 68 23650 46074 53279274
Diabetic ketoacidosis 32.26 10.99 42 23676 19873 53305475
Drug ineffective 30.43 10.99 226 23492 817019 52508329
Torsade de pointes 30.28 10.99 33 23685 12972 53312376
Glossodynia 28.68 10.99 5 23713 100286 53225062
Product use in unapproved indication 27.31 10.99 8 23710 112281 53213067
Bradyarrhythmia 25.21 10.99 14 23704 2029 53323319
Carcinoid tumour of the stomach 24.90 10.99 7 23711 160 53325188
Autoimmune myositis 24.66 10.99 6 23712 76 53325272
Ischaemic cardiomyopathy 24.57 10.99 15 23703 2593 53322755
Maternal exposure during pregnancy 24.42 10.99 20 23698 155619 53169729
Synovitis 23.94 10.99 9 23709 107884 53217464
Renal failure 23.76 10.99 110 23608 118342 53207006
Blood glucose abnormal 23.31 10.99 22 23696 7297 53318051
Infusion related reaction 22.13 10.99 22 23696 155935 53169413
Transient ischaemic attack 20.99 10.99 48 23670 35677 53289671
Blood urea increased 20.98 10.99 40 23678 26191 53299157
Metabolic acidosis 20.79 10.99 53 23665 42189 53283159
Hypoglycaemic unconsciousness 20.68 10.99 9 23709 769 53324579
Enterochromaffin cell hyperplasia 20.57 10.99 5 23713 63 53325285
Oedema peripheral 20.46 10.99 138 23580 170649 53154699
Heart injury 19.98 10.99 10 23708 1173 53324175
Cerebrovascular accident 19.87 10.99 96 23622 105078 53220270
Wound 19.71 10.99 8 23710 91549 53233799
Lower respiratory tract infection 19.51 10.99 8 23710 90973 53234375
Ketoacidosis 19.50 10.99 16 23702 4410 53320938
Fatigue 19.32 10.99 220 23498 730286 52595062
Asthenia 19.13 10.99 235 23483 343355 52981993
Treatment noncompliance 18.98 10.99 44 23674 32991 53292357
Hyperhidrosis 18.75 10.99 89 23629 96704 53228644
Hypergastrinaemia 18.05 10.99 5 23713 108 53325240
Obesity 18.00 10.99 29 23689 16633 53308715
Diabetic retinopathy 17.97 10.99 12 23706 2420 53322928
Acute myocardial infarction 17.73 10.99 43 23675 33192 53292156
Peripheral swelling 17.71 10.99 41 23677 206067 53119281
Pancreatitis acute 17.51 10.99 37 23681 26072 53299276
Febrile neutropenia 17.07 10.99 13 23705 104923 53220425
Hypoglycaemic encephalopathy 16.91 10.99 6 23712 297 53325051
Arthropathy 16.79 10.99 23 23695 141430 53183918
Angina pectoris 16.22 10.99 38 23680 28687 53296661
Macular oedema 16.18 10.99 14 23704 4151 53321197
Intentional product use issue 16.16 10.99 6 23712 72488 53252860
Treatment failure 16.14 10.99 20 23698 128383 53196965
Drug interaction 15.85 10.99 158 23560 219171 53106177
Necrotising myositis 15.78 10.99 6 23712 362 53324986
Rhabdomyolysis 15.63 10.99 49 23669 43874 53281474
Strongyloidiasis 15.60 10.99 8 23710 987 53324361
Rectal adenoma 15.51 10.99 4 23714 65 53325283
Mucosal erosion 15.44 10.99 9 23709 1430 53323918
Drug abuse 15.33 10.99 5 23713 65521 53259827
Hepatic artery thrombosis 15.03 10.99 4 23714 74 53325274
Myocardial ischaemia 14.76 10.99 23 23695 12821 53312527
Sinusitis 14.11 10.99 34 23684 168530 53156818
Hepatic steatosis 14.03 10.99 34 23684 26225 53299123
Anaphylactic reaction 13.85 10.99 57 23661 58269 53267079
Renal cancer recurrent 13.58 10.99 3 23715 24 53325324
Neutropenia 13.40 10.99 32 23686 159153 53166195
Lip discolouration 13.34 10.99 6 23712 554 53324794
Lymphocyte count increased 13.09 10.99 11 23707 3135 53322213
Oral mucosal discolouration 12.91 10.99 5 23713 317 53325031
Pain 12.63 10.99 185 23533 588213 52737135
Pancreatic duct obstruction 12.48 10.99 3 23715 36 53325312
Hypophagia 12.31 10.99 36 23682 31026 53294322
Tobacco abuse 12.20 10.99 6 23712 678 53324670
Leukocyturia 12.08 10.99 7 23711 1100 53324248
Blood creatinine increased 11.88 10.99 70 23648 82592 53242756
Alcoholism 11.84 10.99 9 23709 2222 53323126
Benzodiazepine drug level increased 11.52 10.99 4 23714 186 53325162
Brain death 11.46 10.99 10 23708 2998 53322350
Hip deformity 11.39 10.99 4 23714 192 53325156
Hyperhomocysteinaemia 11.37 10.99 4 23714 193 53325155
Cataract cortical 11.35 10.99 3 23715 54 53325294
In vitro fertilisation 11.30 10.99 3 23715 55 53325293
Anaemia of malignant disease 11.18 10.99 5 23713 456 53324892
Hypersensitivity 11.10 10.99 52 23666 210613 53114735
Acute coronary syndrome 11.06 10.99 18 23700 10406 53314942
Pain in extremity 11.04 10.99 183 23535 284867 53040481
Product use issue 11.02 10.99 29 23689 139555 53185793

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
Hypoglycaemia 1265.99 11.98 694 25868 53688 32433276
Blood glucose increased 232.12 11.98 276 26286 64965 32421999
Blood glucose decreased 175.03 11.98 119 26443 13415 32473549
Myocardial infarction 130.53 11.98 305 26257 125371 32361593
Coronary artery disease 124.54 11.98 177 26385 49529 32437435
Cardiac failure congestive 120.51 11.98 234 26328 84618 32402346
Lactic acidosis 112.75 11.98 138 26424 33398 32453566
Glycosylated haemoglobin increased 94.82 11.98 74 26488 10315 32476649
Hyperglycaemia 79.36 11.98 125 26437 38266 32448698
Blood mercury abnormal 70.89 11.98 19 26543 188 32486776
5-hydroxyindolacetic acid in urine increased 68.74 11.98 19 26543 213 32486751
Off label use 64.67 11.98 94 26468 306226 32180738
Counterfeit product administered 63.72 11.98 17 26545 165 32486799
Blood pressure systolic increased 55.88 11.98 70 26492 17326 32469638
Cerebrovascular accident 49.41 11.98 169 26393 86151 32400813
Low density lipoprotein decreased 46.96 11.98 21 26541 1032 32485932
Arteriosclerosis coronary artery 46.71 11.98 53 26509 11828 32475136
Metabolic acidosis 43.45 11.98 100 26462 40599 32446365
Product contamination 40.99 11.98 17 26545 694 32486270
Drug abuse 40.79 11.98 8 26554 80235 32406729
Product use in unapproved indication 39.76 11.98 11 26551 87193 32399771
Hyperkalaemia 38.54 11.98 135 26427 69615 32417349
Pyrexia 37.50 11.98 135 26427 319833 32167131
Myocardial ischaemia 36.92 11.98 58 26504 17701 32469263
Mental status changes 35.33 11.98 89 26473 38248 32448716
Hyperoxaluria 34.76 11.98 10 26552 131 32486833
Platelet count normal 33.09 11.98 7 26555 21 32486943
Ischaemic cardiomyopathy 31.07 11.98 32 26530 6402 32480562
Hepatic neoplasm 31.03 11.98 20 26542 2058 32484906
Hypoglycaemic coma 30.43 11.98 21 26541 2422 32484542
Death 30.30 11.98 186 26376 382331 32104633
Blood creatinine increased 29.71 11.98 156 26406 95976 32390988
Acute kidney injury 29.31 11.98 367 26195 293101 32193863
Diabetes mellitus inadequate control 28.66 11.98 45 26517 13723 32473241
Expired product administered 28.26 11.98 22 26540 3053 32483911
Hypoglycaemic encephalopathy 27.21 11.98 10 26552 294 32486670
Pancreatitis 25.69 11.98 79 26483 38072 32448892
Scrotal oedema 25.34 11.98 16 26546 1589 32485375
Febrile neutropenia 24.83 11.98 37 26525 119529 32367435
Congenital absence of bile ducts 24.44 11.98 4 26558 0 32486964
Drug ineffective 24.23 11.98 199 26363 383278 32103686
Neutropenia 24.09 11.98 50 26512 142125 32344839
Quadriparesis 23.71 11.98 14 26548 1233 32485731
Haematocrit decreased 23.63 11.98 68 26494 31594 32455370
Neoplasm 23.29 11.98 23 26539 4378 32482586
Oedema peripheral 22.54 11.98 165 26397 113926 32373038
Oliguria 20.11 11.98 29 26533 8205 32478759
Otitis externa 19.86 11.98 12 26550 1102 32485862
Hirsutism 19.75 11.98 7 26555 185 32486779
Emotional distress 19.57 11.98 42 26520 16264 32470700
Hospitalisation 19.15 11.98 8 26554 48963 32438001
Areflexia 19.00 11.98 17 26545 2859 32484105
Vascular resistance systemic decreased 18.83 11.98 6 26556 113 32486851
Pancreatitis acute 18.77 11.98 57 26505 27278 32459686
Pneumonia 18.67 11.98 193 26369 355059 32131905
Shock 18.19 11.98 52 26510 24062 32462902
Treatment failure 17.73 11.98 5 26557 39158 32447806
Blood glucose fluctuation 17.68 11.98 19 26543 3990 32482974
Deafness neurosensory 17.67 11.98 16 26546 2732 32484232
Body temperature decreased 17.61 11.98 32 26530 10982 32475982
Lacunar infarction 17.51 11.98 17 26545 3169 32483795
Nephrocalcinosis 17.50 11.98 9 26553 604 32486360
Hepatic pain 17.47 11.98 12 26550 1373 32485591
Chest pain 17.29 11.98 166 26396 123971 32362993
Diabetic neuropathy 17.10 11.98 19 26543 4141 32482823
Hyperlipidaemia 16.98 11.98 37 26525 14474 32472490
Injury 16.81 11.98 48 26514 22197 32464767
Bladder cancer 16.65 11.98 30 26532 10226 32476738
Blood lactic acid increased 16.64 11.98 23 26539 6258 32480706
Middle ear disorder 16.26 11.98 3 26559 3 32486961
Cutaneous lupus erythematosus 16.01 11.98 9 26553 722 32486242
Asthenia 15.97 11.98 276 26286 235668 32251296
Paratracheal lymphadenopathy 15.85 11.98 5 26557 91 32486873
Blood pH decreased 15.83 11.98 14 26548 2319 32484645
Cardiovascular disorder 15.62 11.98 30 26532 10732 32476232
Poor dental condition 15.39 11.98 6 26556 208 32486756
Cataract 15.28 11.98 49 26513 24134 32462830
Transient ischaemic attack 15.17 11.98 51 26511 25743 32461221
Nasal neoplasm 14.88 11.98 5 26557 112 32486852
Renal failure 14.59 11.98 171 26391 134307 32352657
Thrombocytopenia 14.52 11.98 67 26495 148232 32338732
Diabetic retinopathy 14.42 11.98 12 26550 1831 32485133
Tympanic membrane disorder 14.00 11.98 4 26558 51 32486913
Accidental exposure to product by child 13.67 11.98 11 26551 1600 32485364
Cardiac disorder 13.65 11.98 69 26493 41797 32445167
Product complaint 13.54 11.98 20 26542 5783 32481181
Peripheral vascular disorder 13.51 11.98 19 26543 5253 32481711
Blood glucose 13.32 11.98 3 26559 13 32486951
Renal injury 13.27 11.98 30 26532 12025 32474939
Insulin C-peptide increased 13.22 11.98 4 26558 63 32486901
Intentional overdose 13.17 11.98 68 26494 41533 32445431
COVID-19 12.89 11.98 5 26557 32010 32454954
Sensitisation 12.83 11.98 5 26557 173 32486791
Blood glucose abnormal 12.66 11.98 19 26543 5569 32481395
Apnoea 12.62 11.98 21 26541 6722 32480242
Hyperlactacidaemia 12.57 11.98 14 26548 3060 32483904
Polyuria 12.51 11.98 23 26539 7962 32479002
Pancreatitis chronic 12.40 11.98 12 26550 2228 32484736
Diabetes mellitus 12.39 11.98 71 26491 45102 32441862
Haemolytic anaemia 12.23 11.98 27 26535 10657 32476307

Pharmacologic Action:

SourceCodeDescription
ATC A10BB01 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Sulfonylureas
FDA CS M0020795 Sulfonylurea Compounds
CHEBI has role CHEBI:35526 hypoglycemic drug
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:77194 pantothenate kinase (phosphorylating) inhibitors
CHEBI has role CHEBI:131770 cystic fibrosis transmembrane conductance regulator inhibitors
MeSH PA D007004 Hypoglycemic Agents
FDA EPC N0000175608 Sulfonylurea

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Alcoholism contraindication 7200002
Asthenia contraindication 13791008
Myocardial infarction contraindication 22298006 DOID:5844
Acute vomiting contraindication 23971007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Dehydration contraindication 34095006
Infectious disease contraindication 40733004
Hepatic porphyria contraindication 55056006 DOID:3133
Ketoacidosis contraindication 56051008
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Hemolytic anemia contraindication 61261009 DOID:583
Glucose-6-phosphate dehydrogenase deficiency anemia contraindication 62403005
Hypopituitarism contraindication 74728003 DOID:9406
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Cobalamin deficiency contraindication 190634004
Decompensated cardiac failure contraindication 195111005
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Sepsis syndrome contraindication 238150007
Primary adrenocortical insufficiency contraindication 373662000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Fever contraindication 386661006
Surgical procedure contraindication 387713003
Severe diarrhea contraindication 409587002
Traumatic injury contraindication 417746004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Radiography with IV Iodinated Contrast Agent contraindication
Severe Hypoxemia contraindication
Severe Autonomic Insufficiency contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.31 acidic
pKa2 12.71 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
Sulfonylurea receptor 1, Kir6.2 Ion channel BLOCKER Kd 9.52 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Bile salt export pump Transporter IC50 5.28 CHEMBL
Cytochrome P450 2C9 Enzyme INHIBITOR IC50 5.80 DRUG MATRIX
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor Ki 6.18 CHEMBL
Cystic fibrosis transmembrane conductance regulator Ion channel BLOCKER Ki 4.66 IUPHAR
Sulfonylurea receptor 2, Kir6.2 Ion channel BLOCKER Ki 8.21 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.13 CHEMBL
NACHT, LRR and PYD domains-containing protein 3 Unclassified IC50 4.92 CHEMBL
CDGSH iron-sulfur domain-containing protein 1 Unclassified Ki 5.78 CHEMBL
ATP-sensitive inward rectifier potassium channel 11 Ion channel BLOCKER IC50 5.70 IUPHAR
NACHT, LRR and PYD domains-containing protein 3 Unclassified IC50 5 CHEMBL
Sur1-Trpm4; Sulfonylurea receptor 1 - Transient receptor potential melastatin 4 Ion channel INHIBITOR EC50 7.32 SCIENTIFIC LITERATURE
Bile salt export pump Transporter IC50 5.55 CHEMBL

External reference:

IDSource
4018078 VUID
N0000146417 NUI
D00336 KEGG_DRUG
4018078 VANDF
CHEBI:5441 CHEBI
GBM PDB_CHEM_ID
CHEMBL472 ChEMBL_ID
2414 IUPHAR_LIGAND_ID
2386 INN_ID
DB01016 DRUGBANK_ID
SX6K58TVWC UNII
3488 PUBCHEM_CID
4815 RXNORM
4790 MMSL
597 MMSL
d00248 MMSL
000912 NDDF
384978002 SNOMEDCT_US
80870001 SNOMEDCT_US
D005905 MESH_DESCRIPTOR_UI
C0017628 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Glynase HUMAN PRESCRIPTION DRUG LABEL 1 0009-0341 TABLET 1.50 mg ORAL NDA 26 sections
Glynase HUMAN PRESCRIPTION DRUG LABEL 1 0009-0352 TABLET 3 mg ORAL NDA 26 sections
Glynase HUMAN PRESCRIPTION DRUG LABEL 1 0009-3449 TABLET 6 mg ORAL NDA 26 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8034 TABLET 1.50 mg ORAL ANDA 24 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8035 TABLET 3 mg ORAL ANDA 24 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8036 TABLET 6 mg ORAL ANDA 24 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8342 TABLET 1.25 mg ORAL ANDA 26 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8343 TABLET 2.50 mg ORAL ANDA 26 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-8344 TABLET 5 mg ORAL ANDA 26 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-9364 TABLET 5 mg ORAL NDA AUTHORIZED GENERIC 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-9433 TABLET 2.50 mg ORAL NDA AUTHORIZED GENERIC 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0093-9477 TABLET 1.25 mg ORAL NDA AUTHORIZED GENERIC 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0115-1742 TABLET 1.25 mg ORAL ANDA 22 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0115-1743 TABLET 2.50 mg ORAL ANDA 22 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0115-1744 TABLET 5 mg ORAL ANDA 22 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0929 TABLET 1.25 mg ORAL ANDA 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0930 TABLET 2.50 mg ORAL ANDA 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0931 TABLET 5 mg ORAL ANDA 25 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9918 TABLET 1.50 mg ORAL ANDA 20 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9919 TABLET 3 mg ORAL ANDA 20 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9920 TABLET 6 mg ORAL ANDA 20 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2751 TABLET, FILM COATED 1.25 mg ORAL ANDA 27 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2752 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2753 TABLET, FILM COATED 5 mg ORAL ANDA 27 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 10544-232 TABLET 2.50 mg ORAL ANDA 21 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 10544-300 TABLET 5 mg ORAL ANDA 21 sections
Glyburide-Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10544-579 TABLET 5 mg ORAL ANDA 23 sections
Glyburide-Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10544-580 TABLET 2.50 mg ORAL ANDA 23 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 21695-467 TABLET 2.50 mg ORAL ANDA 22 sections
Glyburide HUMAN PRESCRIPTION DRUG LABEL 1 21695-468 TABLET 5 mg ORAL ANDA 22 sections