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

Stem definitionDrug idCAS RN
anti-inflammatory, indometacin derivatives 1440 53-86-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • indomethacin hydrochloride
  • indomethacin HCl
  • indocin
  • indomethacin
  • indometacine
  • indomethacine
  • indometacin
  • indomethacin sodium
A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Additional data needed to determine whether in vitro activity against SARS-CoV-2 corresponds with clinical efficacy in the treatment of COVID-19.
  • Molecular weight: 357.79
  • Formula: C19H16ClNO4
  • CLOGP: 4.18
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 68.53
  • ALOGS: -5.17
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O
0.10 g R

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) 15 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 7.99 ┬ÁM/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) 0.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 10, 1965 FDA

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
Neck deformity 167.68 12.36 49 14975 1805 46669233
Neck mass 147.71 12.36 51 14973 3242 46667796
Bone density abnormal 120.11 12.36 43 14981 3041 46667997
Disability 100.75 12.36 54 14970 10113 46660925
Drug hypersensitivity 98.76 12.36 232 14792 243593 46427445
Ankylosing spondylitis 90.68 12.36 44 14980 6693 46664345
Oligohydramnios 89.92 12.36 41 14983 5424 46665614
Premature baby 69.90 12.36 53 14971 18059 46652979
Mood swings 68.18 12.36 50 14974 16202 46654836
Neonatal disorder 66.69 12.36 19 15005 638 46670400
Premature delivery 58.69 12.36 52 14972 22017 46649021
Limb deformity 47.05 12.36 23 15001 3553 46667485
Anti-cyclic citrullinated peptide antibody positive 46.75 12.36 43 14981 19102 46651936
Exposure during pregnancy 44.77 12.36 104 14920 108108 46562930
Death 43.78 12.36 27 14997 335521 46335517
Joint stiffness 40.93 12.36 47 14977 27061 46643977
Corneal perforation 39.77 12.36 12 15012 494 46670544
Rheumatoid factor positive 38.79 12.36 40 14984 20421 46650617
Maternal drugs affecting foetus 37.70 12.36 23 15001 5495 46665543
Low birth weight baby 32.96 12.36 21 15003 5413 46665625
Hypermobility syndrome 32.33 12.36 11 15013 668 46670370
Drug ineffective 31.37 12.36 344 14680 677494 45993544
Hypercholesterolaemia 30.32 12.36 27 14997 11503 46659535
Oesophageal spasm 29.84 12.36 14 15010 1975 46669063
Neonatal respiratory distress syndrome 29.51 12.36 15 15009 2518 46668520
Joint swelling 29.05 12.36 118 14906 165955 46505083
Serotonin syndrome 28.45 12.36 37 14987 24183 46646855
Musculoskeletal stiffness 27.03 12.36 81 14943 97912 46573126
Oesophageal pain 26.58 12.36 14 15010 2529 46668509
Arthralgia 26.42 12.36 204 14820 364399 46306639
Therapeutic product effect decreased 26.39 12.36 72 14952 82529 46588509
Polyarthritis 24.92 12.36 19 15005 6523 46664515
Serum ferritin decreased 22.86 12.36 11 15013 1641 46669397
Grip strength decreased 22.32 12.36 20 15004 8586 46662452
Hydrops foetalis 21.94 12.36 7 15017 347 46670691
Adrenal suppression 21.74 12.36 9 15015 942 46670096
Premature labour 21.25 12.36 22 15002 11277 46659761
Patent ductus arteriosus 21.15 12.36 14 15010 3848 46667190
Cerebral vasoconstriction 21.02 12.36 9 15015 1024 46670014
Impaired work ability 20.93 12.36 23 15001 12613 46658425
Ankle fracture 20.28 12.36 25 14999 15486 46655552
Large intestinal ulcer haemorrhage 19.70 12.36 5 15019 107 46670931
Maternal exposure during pregnancy 19.63 12.36 75 14949 102474 46568564
Alpha tumour necrosis factor increased 19.28 12.36 4 15020 33 46671005
Fine motor skill dysfunction 19.27 12.36 13 15011 3687 46667351
Pain 19.25 12.36 236 14788 476712 46194326
Endothelin increased 19.17 12.36 4 15020 34 46671004
Chronic gastritis 18.98 12.36 11 15013 2392 46668646
Treatment failure 18.58 12.36 69 14955 93018 46578020
Hirsutism 18.08 12.36 8 15016 986 46670052
Foetal exposure during pregnancy 17.88 12.36 34 14990 30713 46640325
Apgar score low 17.80 12.36 7 15017 642 46670396
Blood pressure fluctuation 16.89 12.36 33 14991 30415 46640623
Neuralgia 16.81 12.36 27 14997 21356 46649682
Dyspraxia 16.71 12.36 5 15019 200 46670838
Visceral leishmaniasis 16.41 12.36 6 15018 450 46670588
Nerve degeneration 16.26 12.36 4 15020 75 46670963
Migraine 15.76 12.36 54 14970 69972 46601066
Decreased vibratory sense 15.23 12.36 5 15019 272 46670766
Corneal neovascularisation 14.70 12.36 4 15020 113 46670925
Oliguria 14.61 12.36 16 15008 8743 46662295
Catheter site bruise 14.59 12.36 5 15019 310 46670728
Alkalosis 14.53 12.36 5 15019 314 46670724
White blood cell analysis abnormal 14.23 12.36 3 15021 27 46671011
Right ventricular hypertrophy 14.13 12.36 6 15018 669 46670369
Mydriasis 13.78 12.36 17 15007 10536 46660502
Bradycardia foetal 13.73 12.36 5 15019 371 46670667
Lymphoedema 13.11 12.36 15 15009 8597 46662441
Fibromatosis 13.02 12.36 3 15021 42 46670996
Rheumatoid arthritis 12.94 12.36 126 14898 240089 46430949
Premature rupture of membranes 12.92 12.36 11 15013 4412 46666626
Bursitis 12.87 12.36 23 15001 19819 46651219
Pulmonary valve incompetence 12.85 12.36 7 15017 1351 46669687
Metabolic acidosis 12.57 12.36 34 14990 38746 46632292
Atrial fibrillation 12.57 12.36 9 15015 103581 46567457
Ocular toxicity 12.53 12.36 5 15019 476 46670562
Gingival hypertrophy 12.52 12.36 7 15017 1422 46669616
Myoglobin blood increased 12.49 12.36 7 15017 1429 46669609

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
Gout 125.85 13.08 81 11820 17234 29923343
Ankylosing spondylitis 98.48 13.08 44 11857 4490 29936087
Ductus arteriosus premature closure 84.13 13.08 17 11884 95 29940482
Sacroiliitis 49.77 13.08 17 11884 843 29939734
Juvenile idiopathic arthritis 46.57 13.08 17 11884 1026 29939551
Drug hypersensitivity 43.81 13.08 89 11812 68430 29872147
Hepatitis B virus test positive 41.84 13.08 11 11890 218 29940359
Mast cell activation syndrome 39.33 13.08 9 11892 97 29940480
Hypoaldosteronism 39.21 13.08 10 11891 175 29940402
Drug ineffective 35.73 13.08 244 11657 340143 29600434
Arthralgia 34.19 13.08 125 11776 135666 29804911
Duodenal perforation 33.76 13.08 14 11887 1190 29939387
Neonatal disorder 33.72 13.08 13 11888 913 29939664
Exostosis 32.31 13.08 19 11882 3436 29937141
Death 31.45 13.08 59 11842 357224 29583353
Chest expansion decreased 31.42 13.08 8 11893 139 29940438
Axial spondyloarthritis 30.36 13.08 8 11893 160 29940417
Benign abdominal neoplasm 29.53 13.08 7 11894 89 29940488
Gouty arthritis 28.68 13.08 12 11889 1043 29939534
Premature baby 25.02 13.08 32 11869 16659 29923918
Placental transfusion syndrome 24.55 13.08 4 11897 4 29940573
Xanthelasma 24.09 13.08 6 11895 95 29940482
Gastric haemorrhage 22.42 13.08 23 11878 9444 29931133
Hydrops foetalis 22.36 13.08 7 11894 263 29940314
Coarctation of the aorta 22.13 13.08 8 11893 469 29940108
Gastrointestinal haemorrhage 21.97 13.08 78 11823 83368 29857209
Caesarean section 20.64 13.08 12 11889 2125 29938452
Tendon disorder 19.84 13.08 12 11889 2284 29938293
Enthesopathy 19.64 13.08 13 11888 2893 29937684
Ankle fracture 19.20 13.08 14 11887 3637 29936940
Thoracic vertebral fracture 19.19 13.08 10 11891 1430 29939147
Tricuspid valve incompetence 18.72 13.08 20 11881 8603 29931974
Osteopenia 18.27 13.08 15 11886 4633 29935944
Gastric ulcer 18.12 13.08 26 11875 15095 29925482
Water intoxication 18.11 13.08 7 11894 495 29940082
Gastric bypass 18.04 13.08 6 11895 274 29940303
Joint swelling 18.00 13.08 50 11851 46896 29893681
Drug tolerance 17.91 13.08 11 11890 2151 29938426
Procedural vomiting 17.69 13.08 5 11896 131 29940446
Joint range of motion decreased 17.21 13.08 16 11885 5829 29934748
Arthritis 17.14 13.08 33 11868 24368 29916209
Therapeutic product effect incomplete 17.09 13.08 40 11861 33794 29906783
Pulmonary sarcoidosis 17.06 13.08 7 11894 579 29939998
Synovitis 16.66 13.08 20 11881 9763 29930814
Iridocyclitis 16.56 13.08 9 11892 1400 29939177
Joint space narrowing 16.52 13.08 4 11897 56 29940521
Duodenal ulcer 16.47 13.08 20 11881 9881 29930696
Myofascial pain syndrome 16.47 13.08 6 11895 360 29940217
Burns second degree 16.42 13.08 6 11895 363 29940214
Patent ductus arteriosus 16.32 13.08 12 11889 3157 29937420
Sensitivity to weather change 16.29 13.08 9 11892 1445 29939132
Stillbirth 16.04 13.08 5 11896 185 29940392
Tobacco abuse 15.92 13.08 6 11895 396 29940181
Osteoarthritis 15.66 13.08 27 11874 18322 29922255
Sinusitis aspergillus 15.63 13.08 4 11897 71 29940506
Intraventricular haemorrhage neonatal 15.55 13.08 5 11896 205 29940372
Foot fracture 15.44 13.08 13 11888 4159 29936418
Intracranial pressure increased 15.29 13.08 12 11889 3478 29937099
Oromandibular dystonia 15.07 13.08 6 11895 459 29940118
Melaena 14.93 13.08 37 11864 32400 29908177
Adulterated product 14.26 13.08 3 11898 21 29940556
Psoriasis 14.10 13.08 43 11858 42463 29898114
Foetal distress syndrome 13.54 13.08 7 11894 984 29939593
Physical deconditioning 13.26 13.08 6 11895 630 29939947
Cardiomegaly 13.24 13.08 22 11879 14487 29926090

Pharmacologic Action:

SourceCodeDescription
ATC C01EB03 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC M01AB01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA23 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC S01BC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC M01AB51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC S01CC02 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D012102 Reproductive Control Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D015149 Tocolytic Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drugs
CHEBI has role CHEBI:35544 cyclooxygenase inhibitors
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:76206 xenobiotic metabolites
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Tendinitis indication 34840004 DOID:971
Tenosynovitis indication 67801009 DOID:970
Rheumatoid arthritis indication 69896004 DOID:7148
Patent ductus arteriosus indication 83330001 DOID:13832
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Bursitis of shoulder indication 239961006
Osteoarthritis indication 396275006
Synovitis indication 416209007 DOID:2703
Shoulder Tendonitis indication
Pericarditis off-label use 3238004 DOID:1787
Premature labor off-label use 6383007
Renal colic off-label use 7093002
Pseudoprimary hyperaldosteronism off-label use 71275003
Nephrogenic diabetes insipidus off-label use 111395007 DOID:12387
Dysmenorrhea off-label use 266599000
Fever off-label use 386661006
Twin reversal arterial perfusion syndrome off-label use 417006004
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Proctitis contraindication 3951002 DOID:3127
Acute hemorrhage contraindication 8573003
Rectal hemorrhage contraindication 12063002
Hyperkalemia contraindication 14140009
Myocardial infarction contraindication 22298006 DOID:5844
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Stomatitis contraindication 61170000 DOID:9637
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Hemorrhoids contraindication 70153002 DOID:9746
Corneal deposit contraindication 74460005 DOID:11547
Gastrointestinal hemorrhage contraindication 74474003
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Bacterial infectious disease contraindication 87628006
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Blurring of visual image contraindication 111516008
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Sepsis of the newborn contraindication 206376005
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Esophageal dysmotility contraindication 266434009 DOID:9192
Cerebral hemorrhage contraindication 274100004
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Malignant tumor of colon contraindication 363406005 DOID:219
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808
Diverticular disease contraindication 397881000
Smokes tobacco daily contraindication 449868002
Psychiatric Disturbance contraindication
Intraventricular Hemorrhage In Newborn contraindication
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.45 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
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 6.33 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.21 WOMBAT-PK CHEMBL
Prostaglandin D2 receptor 2 GPCR Ki 6.53 WOMBAT-PK
Aldo-keto reductase family 1 member C3 Enzyme IC50 7 CHEMBL
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Prostaglandin E synthase Enzyme IC50 4.39 CHEMBL
Aldo-keto reductase family 1 member C4 Enzyme IC50 4.27 CHEMBL
Androgen receptor Nuclear hormone receptor EC50 9.85 CHEMBL
Multidrug resistance-associated protein 1 Transporter IC50 4.92 CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.44 CHEMBL
Dehydrogenase/reductase SDR family member 9 Enzyme IC50 4.85 CHEMBL
Lactoylglutathione lyase Enzyme Ki 4.74 CHEMBL
Aldose reductase Enzyme IC50 5.22 CHEMBL
Potassium voltage-gated channel subfamily A member 7 Ion channel Ki 7.50 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 4.49 CHEMBL
Prostaglandin E2 receptor EP2 subtype GPCR Ki 7.69 PDSP
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST Kd 7.38 IUPHAR
Aldose reductase Enzyme IC50 5.44 DRUG MATRIX
Aldose reductase Enzyme IC50 5.30 CHEMBL
Prostaglandin G/H synthase (cyclooxygenase) Enzyme IC50 6.82 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.10 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 6.30 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.47 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 8.19 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.70 CHEMBL
Cyclooxygenase Enzyme IC50 7 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 8 CHEMBL
Cyclooxygenase Enzyme IC50 6.37 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.39 CHEMBL
Nitric oxide synthase, inducible Enzyme IC50 4.70 CHEMBL
Prostaglandin D2 receptor 2 Unclassified AGONIST Ki 6 IUPHAR

External reference:

IDSource
D00141 KEGG_DRUG
74252-25-8 SECONDARY_CAS_RN
4017890 VANDF
4017891 VANDF
C0700798 UMLSCUI
CHEBI:49662 CHEBI
IMN PDB_CHEM_ID
CHEMBL6 ChEMBL_ID
CHEMBL3989410 ChEMBL_ID
DB00328 DRUGBANK_ID
D007213 MESH_DESCRIPTOR_UI
1909 IUPHAR_LIGAND_ID
1524 INN_ID
XXE1CET956 UNII
3715 PUBCHEM_CID
1294612 RXNORM
2387 MMSL
2393 MMSL
4877 MMSL
d00039 MMSL
002373 NDDF
002374 NDDF
373513008 SNOMEDCT_US
60149003 SNOMEDCT_US
783274005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 0409-1113 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 0713-0176 SUPPOSITORY 50 mg RECTAL ANDA 14 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-083 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-919 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 12 sections
Indomethacin Human Prescription Drug Label 1 10544-935 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 24 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 10702-016 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 28 sections
INDOMETHACIN ER HUMAN PRESCRIPTION DRUG LABEL 1 12634-160 CAPSULE 75 mg ORAL ANDA 14 sections
INDOMETHACIN ER HUMAN PRESCRIPTION DRUG LABEL 1 12634-838 CAPSULE 75 mg ORAL ANDA 14 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-130 CAPSULE 50 mg ORAL ANDA 24 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-522 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-523 CAPSULE 50 mg ORAL ANDA 23 sections
Indomethacin Human Prescription Drug Label 1 31722-542 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-543 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-565 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 24 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 35356-697 CAPSULE 50 mg ORAL ANDA 27 sections
INDOCIN HUMAN PRESCRIPTION DRUG LABEL 1 42211-101 SUSPENSION 25 mg ORAL NDA 28 sections
INDOCIN HUMAN PRESCRIPTION DRUG LABEL 1 42211-102 SUPPOSITORY 50 mg RECTAL ANDA 29 sections
Tivorbex HUMAN PRESCRIPTION DRUG LABEL 1 42211-201 CAPSULE 20 mg ORAL NDA 28 sections
Tivorbex HUMAN PRESCRIPTION DRUG LABEL 1 42211-202 CAPSULE 40 mg ORAL NDA 28 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 42254-081 CAPSULE 50 mg ORAL ANDA 27 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 42254-237 CAPSULE 25 mg ORAL ANDA 25 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-368 CAPSULE 25 mg ORAL ANDA 29 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-773 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-777 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-929 CAPSULE 50 mg ORAL ANDA 29 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-930 CAPSULE 50 mg ORAL ANDA 29 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 49349-776 CAPSULE 50 mg ORAL ANDA 24 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 49999-371 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 12 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0051 CAPSULE 50 mg ORAL ANDA 32 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0053 CAPSULE 25 mg ORAL ANDA 32 sections