Stem definition | Drug id | CAS RN |
---|---|---|
56 | 59-66-5 |
Dose | Unit | Route |
---|---|---|
0.75 | g | O |
0.75 | g | P |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Benet LZ, Broccatelli F, Oprea TI |
S (Water solubility) | 0.64 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 90 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 75.14 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Vd (Volume of distribution) | 0.37 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 0.65 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.04 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 13 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
July 27, 1953 | FDA | TEVA BRANDED PHARM |
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 |
---|---|---|---|---|---|---|
Idiopathic intracranial hypertension | 163.99 | 17.35 | 42 | 5815 | 2467 | 46677738 |
Hair follicle tumour benign | 131.53 | 17.35 | 25 | 5832 | 357 | 46679848 |
Intraocular pressure increased | 116.11 | 17.35 | 39 | 5818 | 5918 | 46674287 |
Angle closure glaucoma | 107.14 | 17.35 | 29 | 5828 | 2110 | 46678095 |
Intracranial pressure increased | 103.99 | 17.35 | 33 | 5824 | 4187 | 46676018 |
Metabolic acidosis | 103.50 | 17.35 | 63 | 5794 | 38717 | 46641488 |
Papilloedema | 92.41 | 17.35 | 29 | 5828 | 3548 | 46676657 |
Off label use | 64.83 | 17.35 | 145 | 5712 | 379696 | 46300509 |
Complications of bone marrow transplant | 57.53 | 17.35 | 13 | 5844 | 446 | 46679759 |
Hepatosplenic T-cell lymphoma | 53.47 | 17.35 | 13 | 5844 | 615 | 46679590 |
Retinal detachment | 49.52 | 17.35 | 20 | 5837 | 5080 | 46675125 |
Macular detachment | 46.09 | 17.35 | 8 | 5849 | 66 | 46680139 |
Flat anterior chamber of eye | 40.30 | 17.35 | 7 | 5850 | 58 | 46680147 |
Acute generalised exanthematous pustulosis | 37.82 | 17.35 | 20 | 5837 | 9385 | 46670820 |
Intellectual disability | 37.71 | 17.35 | 10 | 5847 | 672 | 46679533 |
Hypercapnia | 37.67 | 17.35 | 16 | 5841 | 4610 | 46675595 |
Choroidal effusion | 37.03 | 17.35 | 9 | 5848 | 425 | 46679780 |
Aggression | 36.58 | 17.35 | 27 | 5830 | 22717 | 46657488 |
Hypotony of eye | 34.55 | 17.35 | 7 | 5850 | 141 | 46680064 |
Choroidal detachment | 33.03 | 17.35 | 7 | 5850 | 177 | 46680028 |
Corneal oedema | 32.95 | 17.35 | 11 | 5846 | 1635 | 46678570 |
Psychiatric decompensation | 28.56 | 17.35 | 9 | 5848 | 1114 | 46679091 |
Persecutory delusion | 28.22 | 17.35 | 11 | 5846 | 2544 | 46677661 |
Iridocyclitis | 27.11 | 17.35 | 10 | 5847 | 1990 | 46678215 |
Myasthenic syndrome | 26.19 | 17.35 | 6 | 5851 | 219 | 46679986 |
Glaucoma | 25.82 | 17.35 | 19 | 5838 | 15902 | 46664303 |
Product use in unapproved indication | 25.78 | 17.35 | 43 | 5814 | 90230 | 46589975 |
Photophobia | 25.05 | 17.35 | 18 | 5839 | 14526 | 46665679 |
Retinopathy haemorrhagic | 24.94 | 17.35 | 4 | 5853 | 19 | 46680186 |
Lens dislocation | 24.61 | 17.35 | 4 | 5853 | 21 | 46680184 |
Retroperitoneal oedema | 24.45 | 17.35 | 4 | 5853 | 22 | 46680183 |
Cerebral venous sinus thrombosis | 24.28 | 17.35 | 9 | 5848 | 1816 | 46678389 |
CSF pressure increased | 23.65 | 17.35 | 5 | 5852 | 125 | 46680080 |
Visual impairment | 23.52 | 17.35 | 35 | 5822 | 66654 | 46613551 |
Ocular pemphigoid | 23.50 | 17.35 | 4 | 5853 | 29 | 46680176 |
Sickle cell anaemia with crisis | 23.49 | 17.35 | 11 | 5846 | 3981 | 46676224 |
Optic disc haemorrhage | 22.54 | 17.35 | 4 | 5853 | 38 | 46680167 |
Ocular surface disease | 22.44 | 17.35 | 4 | 5853 | 39 | 46680166 |
Visual field defect | 21.84 | 17.35 | 12 | 5845 | 6071 | 46674134 |
Metabolic alkalosis | 20.99 | 17.35 | 9 | 5848 | 2651 | 46677554 |
Foetal exposure during pregnancy | 20.19 | 17.35 | 22 | 5835 | 30725 | 46649480 |
Vision blurred | 20.17 | 17.35 | 36 | 5821 | 79672 | 46600533 |
Conjunctival hyperaemia | 20.00 | 17.35 | 8 | 5849 | 1981 | 46678224 |
Acidosis | 19.63 | 17.35 | 14 | 5843 | 11160 | 46669045 |
Vitreous disorder | 19.58 | 17.35 | 4 | 5853 | 84 | 46680121 |
Drug ineffective | 19.39 | 17.35 | 148 | 5709 | 677690 | 46002515 |
Splenomegaly | 19.04 | 17.35 | 13 | 5844 | 9675 | 46670530 |
Retinal vascular occlusion | 18.60 | 17.35 | 5 | 5852 | 354 | 46679851 |
Diplopia | 18.49 | 17.35 | 17 | 5840 | 19388 | 46660817 |
Dropped head syndrome | 18.28 | 17.35 | 4 | 5853 | 118 | 46680087 |
Serous retinal detachment | 17.91 | 17.35 | 4 | 5853 | 130 | 46680075 |
Single umbilical artery | 17.68 | 17.35 | 4 | 5853 | 138 | 46680067 |
Nasal flaring | 17.36 | 17.35 | 3 | 5854 | 24 | 46680181 |
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 |
---|---|---|---|---|---|---|
Intraocular pressure increased | 194.13 | 21.94 | 53 | 2928 | 5067 | 29944430 |
Choroidal detachment | 125.30 | 21.94 | 23 | 2958 | 345 | 29949152 |
Metabolic acidosis | 108.18 | 21.94 | 59 | 2922 | 37402 | 29912095 |
Angle closure glaucoma | 103.72 | 21.94 | 22 | 2959 | 712 | 29948785 |
Choroidal effusion | 80.36 | 21.94 | 14 | 2967 | 153 | 29949344 |
Toxic epidermal necrolysis | 53.75 | 21.94 | 29 | 2952 | 17911 | 29931586 |
Congenital emphysema | 49.30 | 21.94 | 6 | 2975 | 0 | 29949497 |
Glaucoma | 44.22 | 21.94 | 18 | 2963 | 5890 | 29943607 |
Visual acuity reduced | 40.29 | 21.94 | 23 | 2958 | 15823 | 29933674 |
Hyphaema | 39.66 | 21.94 | 9 | 2972 | 399 | 29949098 |
Ocular surface disease | 39.65 | 21.94 | 7 | 2974 | 83 | 29949414 |
Idiopathic intracranial hypertension | 36.55 | 21.94 | 9 | 2972 | 569 | 29948928 |
Open angle glaucoma | 32.85 | 21.94 | 7 | 2974 | 231 | 29949266 |
Anterior chamber disorder | 31.00 | 21.94 | 6 | 2975 | 121 | 29949376 |
Hypochloraemia | 30.80 | 21.94 | 8 | 2973 | 627 | 29948870 |
Photocoagulation | 26.43 | 21.94 | 4 | 2977 | 16 | 29949481 |
Acidosis hyperchloraemic | 26.06 | 21.94 | 6 | 2975 | 284 | 29949213 |
Hypocapnia | 25.82 | 21.94 | 5 | 2976 | 101 | 29949396 |
Trabeculectomy | 25.23 | 21.94 | 4 | 2977 | 23 | 29949474 |
Corneal oedema | 25.06 | 21.94 | 8 | 2973 | 1304 | 29948193 |
Dysmetria | 24.68 | 21.94 | 6 | 2975 | 359 | 29949138 |
Intracranial pressure increased | 23.96 | 21.94 | 10 | 2971 | 3480 | 29946017 |
Hypercapnia | 23.08 | 21.94 | 10 | 2971 | 3814 | 29945683 |
Visual acuity tests abnormal | 22.04 | 21.94 | 4 | 2977 | 56 | 29949441 |
Corneal opacity | 21.94 | 21.94 | 6 | 2975 | 573 | 29948924 |
Source | Code | Description |
---|---|---|
ATC | S01EC01 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Carbonic anhydrase inhibitors |
FDA CS | M0020790 | Sulfonamides |
FDA MoA | N0000000235 | Carbonic Anhydrase Inhibitors |
FDA EPC | N0000175517 | Carbonic Anhydrase Inhibitor |
MeSH PA | D000927 | Anticonvulsants |
MeSH PA | D002257 | Carbonic Anhydrase Inhibitors |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D004232 | Diuretics |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D045283 | Natriuretic Agents |
CHEBI has role | CHEBI:23018 | carbonate dehydratase inhibitor |
CHEBI has role | CHEBI:35498 | diuretics |
CHEBI has role | CHEBI:35623 | antiepileptic |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Malignant glaucoma | indication | 10100008 | |
Anoxia due to high altitude | indication | 42883007 | |
Absence seizure | indication | 79631006 | |
Open-angle glaucoma | indication | 84494001 | DOID:1067 |
Secondary glaucoma | indication | 95717004 | |
Edema | indication | 267038008 | |
Peripheral edema | indication | 271809000 | |
Angle-closure glaucoma | indication | 392291006 | DOID:13550 |
Peripheral Edema due to Chronic Heart Failure | indication | ||
Metabolic alkalosis | off-label use | 1388004 | |
Myoclonic seizure | off-label use | 37356005 | |
Idiopathic intracranial hypertension | off-label use | 68267002 | DOID:11459 |
Benign intracranial hypertension | off-label use | 68267002 | DOID:11459 |
Familial hypokalemic periodic paralysis | off-label use | 82732003 | DOID:14452 |
Epilepsy | off-label use | 84757009 | DOID:1826 |
Obstructive hydrocephalus | off-label use | 230746009 | DOID:14159 |
Familial periodic paralysis | off-label use | 267607008 | DOID:1029 |
Tonic-clonic epilepsy | off-label use | 352818000 | DOID:7725 |
Simple partial seizure | off-label use | 117891000119100 | |
Urine Alkalinization | off-label use | ||
Hydrocephalus due to Intraventricular Hemorrhage | off-label use | ||
Mixed Epilepsy | off-label use | ||
Renal tubular acidosis | contraindication | 1776003 | DOID:14219 |
Respiratory acidosis | contraindication | 12326000 | |
Hyperkalemia | contraindication | 14140009 | |
Metabolic acidosis, normal anion gap, acidifying salts | contraindication | 18104000 | |
Diabetes mellitus type 2 | contraindication | 44054006 | DOID:9352 |
Diabetes mellitus type 1 | contraindication | 46635009 | DOID:9744 |
Acute nephropathy | contraindication | 58574008 | |
Hepatic failure | contraindication | 59927004 | |
Decreased respiratory function | contraindication | 80954004 | |
Hyponatremia | contraindication | 89627008 | |
Gout | contraindication | 90560007 | DOID:13189 |
Kidney disease | contraindication | 90708001 | DOID:557 |
Disease of blood AND/OR blood-forming organ | contraindication | 191124002 | DOID:74 |
Disease of liver | contraindication | 235856003 | DOID:409 |
Disorder of electrolytes | contraindication | 237840007 | |
Primary adrenocortical insufficiency | contraindication | 373662000 | |
Recurrent Calcium Renal Calculi | contraindication |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 8.04 | acidic |
pKa2 | 9.21 | acidic |
pKa3 | 1.84 | Basic |
None
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Carbonic anhydrase 12 | Enzyme | INHIBITOR | Ki | 8.60 | CHEMBL | CHEMBL | |||
Carbonic anhydrase 4 | Enzyme | INHIBITOR | Ki | 7.96 | CHEMBL | CHEMBL | |||
Carbonic anhydrase 1 | Enzyme | INHIBITOR | Ki | 7.92 | CHEMBL | CHEMBL | |||
Carbonic anhydrase 2 | Enzyme | INHIBITOR | Ki | 8.48 | CHEMBL | CHEMBL | |||
Carbonic anhydrase 5A, mitochondrial | Enzyme | Ki | 7.22 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 9.10 | CHEMBL | |||||
Carbonic anhydrase 14 | Enzyme | Ki | 7.39 | CHEMBL | |||||
Carbonic anhydrase 7 | Enzyme | Ki | 8.60 | CHEMBL | |||||
Carbonic anhydrase 9 | Enzyme | Ki | 8.05 | CHEMBL | |||||
Carbonic anhydrase V | Enzyme | Ki | 8.74 | CHEMBL | |||||
Carbonic anhydrase 5B, mitochondrial | Enzyme | Ki | 7.27 | CHEMBL | |||||
Carbonic anhydrase 3 | Enzyme | Ki | 8.51 | CHEMBL | |||||
Carbonic anhydrase 13 | Enzyme | Ki | 8.24 | CHEMBL | |||||
Carbonic anhydrase 6 | Enzyme | Ki | 7.96 | CHEMBL | |||||
Aquaporin-1 | Transporter | WOMBAT-PK | |||||||
Carbonic anhydrase 2 | Unclassified | Ki | 8 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.09 | CHEMBL | |||||
Carbonic anhydrase | Unclassified | Ki | 5.24 | CHEMBL | |||||
Carbonic anhydrase 2 | Enzyme | IC50 | 6.02 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 4.92 | CHEMBL | |||||
Carbonic anhydrase 13 | Enzyme | Ki | 7.77 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.70 | CHEMBL | |||||
Carbonic anhydrase 15 | Enzyme | Ki | 7.14 | CHEMBL | |||||
Alpha carbonic anhydrase | Unclassified | Ki | 7.80 | CHEMBL | |||||
Carbonic anhydrase 7 | Enzyme | Ki | 7.80 | CHEMBL | |||||
Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase | Enzyme | Ki | 7.92 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | IC50 | 7.80 | CHEMBL | |||||
Endochitinase | Enzyme | Ki | 4.68 | CHEMBL | |||||
Carbonic anhydrase 3 | Enzyme | Ki | 4.08 | CHEMBL | |||||
Astrosclerin-3 | Unclassified | Ki | 7.29 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.40 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.22 | CHEMBL | |||||
Beta-carbonic anhydrase 1 | Enzyme | Ki | 6.60 | CHEMBL | |||||
Carbonic anhydrase 2 | Enzyme | Ki | 8.05 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.96 | CHEMBL | |||||
Carbonic anhydrase 4 | Enzyme | Ki | 7.15 | CHEMBL | |||||
Carbonic anhydrase | Enzyme | Ki | 7.57 | CHEMBL | |||||
Carbonic anhydrase | Unclassified | Ki | 7.56 | CHEMBL | |||||
Carbonic anhydrase 1; GH09688p | Enzyme | Ki | 6.97 | CHEMBL | |||||
Carbonic anhydrase | Unclassified | Ki | 7.12 | CHEMBL | |||||
Carbonic anhydrase 2, isoform A; LD26647p | Enzyme | Ki | 7.11 | CHEMBL | |||||
Carbonic anhydrase | Unclassified | Ki | 7.13 | CHEMBL | |||||
Delta carbonic anhydrase | Unclassified | Ki | 7.08 | CHEMBL |
ID | Source |
---|---|
O3FX965V0I | UNII |
4017898 | VUID |
N0000146250 | NUI |
D00218 | KEGG_DRUG |
1424-27-7 | SECONDARY_CAS_RN |
C0000981 | UMLSCUI |
CHEBI:27690 | CHEBI |
AZM | PDB_CHEM_ID |
CHEMBL20 | ChEMBL_ID |
CHEMBL1200814 | ChEMBL_ID |
1986 | PUBCHEM_CID |
DB00819 | DRUGBANK_ID |
D000086 | MESH_DESCRIPTOR_UI |
481 | INN_ID |
6792 | IUPHAR_LIGAND_ID |
167 | RXNORM |
2596 | MMSL |
4121 | MMSL |
814 | MMSL |
d00161 | MMSL |
002286 | NDDF |
002287 | NDDF |
33664007 | SNOMEDCT_US |
372709008 | SNOMEDCT_US |
72469007 | SNOMEDCT_US |
4017898 | VANDF |
4017899 | VANDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9503 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg | INTRAVENOUS | ANDA | 20 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1050 | TABLET | 250 mg | ORAL | ANDA | 19 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6663 | TABLET | 250 mg | ORAL | ANDA | 18 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-567 | TABLET | 250 mg | ORAL | ANDA | 18 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-120 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 11 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-287 | TABLET | 125 mg | ORAL | ANDA | 18 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-288 | TABLET | 250 mg | ORAL | ANDA | 18 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-787 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 12 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29033-030 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 22 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-0190 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg | INTRAVENOUS | ANDA | 13 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-089 | TABLET | 125 mg | ORAL | ANDA | 18 sections |
acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-090 | TABLET | 250 mg | ORAL | ANDA | 18 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-103 | TABLET | 250 mg | ORAL | ANDA | 19 sections |
ACETAZOLAMIDE EXTENDED-RELEASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-243 | CAPSULE | 500 mg | ORAL | ANDA | 21 sections |
Acetazolamide | Human Prescription Drug Label | 1 | 46708-349 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 21 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-3003 | TABLET | 250 mg | ORAL | ANDA | 19 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-3003 | TABLET | 250 mg | ORAL | ANDA | 19 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-3132 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 11 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4511 | TABLET | 125 mg | ORAL | ANDA | 18 sections |
Acetazolamide | Human Prescription Drug Label | 1 | 50090-5217 | TABLET | 125 mg | ORAL | ANDA | 18 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-054 | TABLET | 250 mg | ORAL | ANDA | 17 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-233 | CAPSULE, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 18 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4022 | TABLET | 125 mg | ORAL | ANDA | 20 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4023 | TABLET | 250 mg | ORAL | ANDA | 20 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-884 | TABLET | 125 mg | ORAL | ANDA | 20 sections |
AcetaZOLAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-885 | TABLET | 250 mg | ORAL | ANDA | 20 sections |
ACETAZOLAMIDE | Human Prescription Drug Label | 1 | 52817-200 | TABLET | 125 mg | ORAL | ANDA | 18 sections |
ACETAZOLAMIDE | Human Prescription Drug Label | 1 | 52817-201 | TABLET | 250 mg | ORAL | ANDA | 18 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-1195 | TABLET | 250 mg | ORAL | ANDA | 11 sections |
Acetazolamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55289-720 | TABLET | 125 mg | ORAL | ANDA | 20 sections |