indomethacin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| anti-inflammatory, indometacin derivatives | 1440 | 53-86-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
| 0.10 | g | P |
| 0.10 | g | R |
| 0.10 | g | O |
| 0.10 | g | R |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 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) | 0.10 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 10, 1965 | FDA |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 688.36 | 44.01 | 191 | 614 | 46452 | 2310828 |
| Neck deformity | 177.27 | 44.01 | 23 | 782 | 59 | 2357221 |
| Drug ineffective | 168.53 | 44.01 | 85 | 720 | 101539 | 2255741 |
| Neck mass | 150.12 | 44.01 | 24 | 781 | 342 | 2356938 |
| Premature baby | 145.64 | 44.01 | 33 | 772 | 3171 | 2354109 |
| Anti-cyclic citrullinated peptide antibody positive | 140.88 | 44.01 | 21 | 784 | 182 | 2357098 |
| Exposure during pregnancy | 128.42 | 44.01 | 47 | 758 | 25172 | 2332108 |
| Bone density abnormal | 125.28 | 44.01 | 21 | 784 | 406 | 2356874 |
| Acute kidney injury | 119.81 | 44.01 | 46 | 759 | 28076 | 2329204 |
| Disability | 117.63 | 44.01 | 22 | 783 | 810 | 2356470 |
| Premature delivery | 103.33 | 44.01 | 25 | 780 | 3175 | 2354105 |
| Rheumatoid factor positive | 101.31 | 44.01 | 18 | 787 | 494 | 2356786 |
| Maternal exposure during pregnancy | 99.44 | 44.01 | 34 | 771 | 14829 | 2342451 |
| Mood swings | 97.70 | 44.01 | 24 | 781 | 3245 | 2354035 |
| Joint swelling | 91.54 | 44.01 | 33 | 772 | 16786 | 2340494 |
| Rheumatoid arthritis | 87.38 | 44.01 | 33 | 772 | 19107 | 2338173 |
| Vomiting | 84.13 | 44.01 | 48 | 757 | 71554 | 2285726 |
| Neonatal disorder | 83.94 | 44.01 | 14 | 791 | 261 | 2357019 |
| Arthralgia | 79.12 | 44.01 | 42 | 763 | 54243 | 2303037 |
| Asthenia | 78.97 | 44.01 | 40 | 765 | 46886 | 2310394 |
| Treatment failure | 78.80 | 44.01 | 24 | 781 | 7215 | 2350065 |
| Maternal drugs affecting foetus | 75.95 | 44.01 | 17 | 788 | 1530 | 2355750 |
| Joint stiffness | 73.63 | 44.01 | 20 | 785 | 4003 | 2353277 |
| Musculoskeletal stiffness | 70.19 | 44.01 | 25 | 780 | 12222 | 2345058 |
| Pain | 68.59 | 44.01 | 40 | 765 | 61817 | 2295463 |
| Nausea | 66.66 | 44.01 | 49 | 756 | 112140 | 2245140 |
| Headache | 66.37 | 44.01 | 43 | 762 | 80136 | 2277144 |
| Therapeutic product effect decreased | 61.71 | 44.01 | 22 | 783 | 10767 | 2346513 |
| Metabolic acidosis | 61.48 | 44.01 | 19 | 786 | 5979 | 2351301 |
| Neonatal respiratory distress syndrome | 61.40 | 44.01 | 12 | 793 | 556 | 2356724 |
| Product use issue | 51.87 | 44.01 | 20 | 785 | 12149 | 2345131 |
| Foetal exposure during pregnancy | 51.12 | 44.01 | 16 | 789 | 5236 | 2352044 |
| Oligohydramnios | 49.56 | 44.01 | 11 | 794 | 949 | 2356331 |
| Cerebral vasoconstriction | 48.60 | 44.01 | 9 | 796 | 311 | 2356969 |
| Low birth weight baby | 45.56 | 44.01 | 10 | 795 | 819 | 2356461 |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 211.02 | 40.00 | 67 | 700 | 15068 | 1730946 |
| Acute kidney injury | 180.08 | 40.00 | 74 | 693 | 34870 | 1711144 |
| Gastrointestinal haemorrhage | 126.11 | 40.00 | 45 | 722 | 14222 | 1731792 |
| Ductus arteriosus premature closure | 120.50 | 40.00 | 16 | 751 | 27 | 1745987 |
| Melaena | 92.82 | 40.00 | 28 | 739 | 5182 | 1740832 |
| Completed suicide | 74.65 | 40.00 | 32 | 735 | 16280 | 1729734 |
| Drug ineffective | 71.59 | 40.00 | 49 | 718 | 63752 | 1682262 |
| Gastric ulcer | 68.04 | 40.00 | 19 | 748 | 2666 | 1743348 |
| Gastric haemorrhage | 66.09 | 40.00 | 19 | 748 | 2959 | 1743055 |
| Gout | 63.95 | 40.00 | 18 | 749 | 2598 | 1743416 |
| Mast cell activation syndrome | 63.09 | 40.00 | 8 | 759 | 7 | 1746007 |
| Premature baby | 61.86 | 40.00 | 18 | 749 | 2924 | 1743090 |
| Hypoaldosteronism | 54.13 | 40.00 | 8 | 759 | 38 | 1745976 |
| Blood urea increased | 53.51 | 40.00 | 18 | 749 | 4693 | 1741321 |
| Dehydration | 53.41 | 40.00 | 26 | 741 | 17632 | 1728382 |
| Blood creatinine increased | 46.59 | 40.00 | 22 | 745 | 13924 | 1732090 |
| Hyperkalaemia | 46.47 | 40.00 | 19 | 748 | 8528 | 1737486 |
| Anaemia | 46.05 | 40.00 | 28 | 739 | 29429 | 1716585 |
| Hydrops foetalis | 44.80 | 40.00 | 7 | 760 | 51 | 1745963 |
| Neonatal disorder | 43.74 | 40.00 | 9 | 758 | 340 | 1745674 |
| Duodenal perforation | 42.67 | 40.00 | 8 | 759 | 185 | 1745829 |
| Duodenal ulcer | 42.48 | 40.00 | 12 | 755 | 1748 | 1744266 |
| Tricuspid valve incompetence | 41.75 | 40.00 | 11 | 756 | 1235 | 1744779 |
| Dyspnoea | 40.07 | 40.00 | 32 | 735 | 52027 | 1693987 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 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 |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35845 | gout suppressant |
| CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory drug |
| FDA Chemical/Ingredient | N0000175721 | Nonsteroidal Anti-inflammatory Compounds |
| MeSH PA | D015149 | Tocolytic Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.45 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG | TIVORBEX | GENUS | N204768 | Feb. 24, 2014 | RX | CAPSULE | ORAL | 9089471 | April 23, 2030 | TREATMENT OF PAIN |
| 40MG | TIVORBEX | GENUS | N204768 | Feb. 24, 2014 | RX | CAPSULE | ORAL | 9089471 | April 23, 2030 | TREATMENT OF PAIN |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| ID | Source |
|---|---|
| D007213 | MESH_DESCRIPTOR_UI |
| C0700798 | UMLSCUI |
| D00141 | KEGG_DRUG |
| 0IMX38M2GG | UNII |
| 74252-25-8 | SECONDARY_CAS_RN |
| 373513008 | SNOMEDCT_US |
| 60149003 | SNOMEDCT_US |
| 2393 | MMSL |
| 5781 | RXNORM |
| 4877 | MMSL |
| d00039 | MMSL |
| 4017890 | VANDF |
| 002373 | NDDF |
| CHEMBL6 | ChEMBL_ID |
| DB00328 | DRUGBANK_ID |
| IMN | PDB_CHEM_ID |
| CHEBI:49662 | CHEBI |
| 1524 | INN_ID |
| CHEMBL3989410 | ChEMBL_ID |
| 3715 | PUBCHEM_CID |
| 1909 | IUPHAR_LIGAND_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1113 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1 mg | INTRAVENOUS | ANDA | 10 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 | 15 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-919 | CAPSULE, EXTENDED RELEASE | 75 mg | ORAL | ANDA | 13 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-935 | CAPSULE, EXTENDED RELEASE | 75 mg | ORAL | ANDA | 13 sections |
| INDOMETHACIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10702-016 | CAPSULE, EXTENDED RELEASE | 75 mg | ORAL | ANDA | 13 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 | 13 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-522 | CAPSULE | 25 mg | ORAL | ANDA | 15 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-523 | CAPSULE | 50 mg | ORAL | ANDA | 13 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-010 | CAPSULE | 25 mg | ORAL | NDA | 18 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-011 | CAPSULE | 50 mg | ORAL | NDA | 18 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-542 | CAPSULE | 25 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-543 | CAPSULE | 50 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-565 | CAPSULE, EXTENDED RELEASE | 75 mg | ORAL | ANDA | 13 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 35356-697 | CAPSULE | 50 mg | ORAL | ANDA | 14 sections |
| INDOCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42211-101 | SUSPENSION | 25 mg | ORAL | NDA | 19 sections |
| INDOCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42211-102 | SUPPOSITORY | 50 mg | RECTAL | ANDA | 19 sections |
| Tivorbex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42211-201 | CAPSULE | 20 mg | ORAL | NDA | 19 sections |
| Tivorbex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42211-202 | CAPSULE | 40 mg | ORAL | NDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-081 | CAPSULE | 50 mg | ORAL | ANDA | 15 sections |
| INDOMETHACIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-237 | CAPSULE | 25 mg | ORAL | ANDA | 12 sections |
| indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42708-030 | CAPSULE | 50 mg | ORAL | ANDA | 20 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-368 | CAPSULE | 25 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-594 | CAPSULE | 25 mg | ORAL | NDA | 18 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-773 | CAPSULE | 25 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-777 | CAPSULE | 50 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-929 | CAPSULE | 50 mg | ORAL | ANDA | 19 sections |
| Indomethacin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-930 | CAPSULE | 50 mg | ORAL | ANDA | 19 sections |