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

Stem definitionDrug idCAS RN
prostaglandins 1817 59122-46-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • misoprostol
  • cytotec
  • isprelor
  • misoprost
  • misoprostil
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
  • Molecular weight: 382.54
  • Formula: C22H38O5
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 83.83
  • ALOGS: -4.37
  • ROTB: 14

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.80 mg O
0.20 mg O
0.20 mg V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1988 FDA GD SEARLE LLC

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
Abortion incomplete 8022.51 13.91 1435 27509 1829 46655289
Haemorrhage 3927.69 13.91 1415 27529 53454 46603664
Pregnancy 1403.71 13.91 554 28390 26583 46630535
Endometritis 823.02 13.91 176 28768 803 46656315
Anaemia 344.37 13.91 588 28356 255191 46401927
Muscle spasms 322.54 13.91 389 28555 122724 46534394
Induced abortion failed 201.35 13.91 44 28900 226 46656892
Pain 182.88 13.91 678 28266 476270 46180848
Retained products of conception 161.35 13.91 32 28912 91 46657027
International normalised ratio fluctuation 157.36 13.91 57 28887 2136 46654982
Drug ineffective for unapproved indication 150.40 13.91 105 28839 16308 46640810
Pulmonary mass 149.24 13.91 108 28836 17749 46639369
Ruptured ectopic pregnancy 132.01 13.91 34 28910 385 46656733
Uterine rupture 124.88 13.91 40 28904 1024 46656094
Ectopic pregnancy 123.72 13.91 50 28894 2532 46654586
Pelvic inflammatory disease 122.15 13.91 44 28900 1622 46655496
Exposure during pregnancy 120.93 13.91 230 28714 107982 46549136
Vaginal haemorrhage 101.90 13.91 101 28843 25503 46631615
Death 93.07 13.91 46 28898 335502 46321616
Pelvic pain 89.77 13.91 67 28877 11535 46645583
Uterine haemorrhage 83.33 13.91 42 28902 3575 46653543
Rheumatoid arthritis 81.26 13.91 329 28615 239886 46417232
Abortion induced incomplete 80.76 13.91 14 28930 12 46657106
Bloody discharge 79.57 13.91 28 28916 963 46656155
Post abortion infection 78.10 13.91 13 28931 6 46657112
Infection 65.71 13.91 207 28737 133385 46523733
Anti-cyclic citrullinated peptide antibody positive 64.38 13.91 69 28875 19076 46638042
Rheumatoid factor positive 64.02 13.91 71 28873 20390 46636728
Disease recurrence 62.87 13.91 67 28877 18404 46638714
Lower respiratory tract infection 62.57 13.91 118 28826 54971 46602147
Syncope 61.60 13.91 173 28771 104630 46552488
Abdominal pain 57.40 13.91 288 28656 229743 46427375
Postpartum haemorrhage 57.03 13.91 26 28918 1771 46655347
Completed suicide 54.33 13.91 12 28932 145908 46511210
Lyme disease 53.15 13.91 27 28917 2336 46654782
Haemorrhage in pregnancy 53.07 13.91 24 28920 1604 46655514
Ejection fraction 52.44 13.91 18 28926 574 46656544
Foetal death 51.50 13.91 43 28901 8700 46648418
Abortion 51.46 13.91 26 28918 2224 46654894
Neutropenia 50.91 13.91 13 28931 143191 46513927
Product use in unapproved indication 47.25 13.91 143 28801 90130 46566988
Drug hypersensitivity 47.20 13.91 285 28659 243540 46413578
Product dose omission issue 46.78 13.91 23 28921 168497 46488621
Toxicity to various agents 46.33 13.91 38 28906 211728 46445390
Complication of device insertion 43.81 13.91 31 28913 4913 46652205
Gestational diabetes 43.55 13.91 36 28908 7183 46649935
Small for dates baby 42.30 13.91 27 28917 3610 46653508
Uterine tenderness 41.99 13.91 8 28936 17 46657101
Abortion induced 41.78 13.91 41 28903 10219 46646899
Vaginal odour 40.86 13.91 14 28930 444 46656674
Pyrexia 40.61 13.91 361 28583 348441 46308677
Acute kidney injury 39.59 13.91 53 28891 235802 46421316
Post abortion complication 39.38 13.91 7 28937 8 46657110
Asthenopia 37.18 13.91 20 28924 1946 46655172
Dizziness 35.92 13.91 345 28599 340069 46317049
Thrombocytopenia 35.54 13.91 17 28927 126564 46530554
Induced abortion haemorrhage 34.69 13.91 6 28938 5 46657113
Pelvic infection 34.29 13.91 11 28933 283 46656835
Procedural pain 33.32 13.91 41 28903 13138 46643980
Uterine perforation 33.31 13.91 31 28913 7236 46649882
Stillbirth 32.31 13.91 29 28915 6462 46650656
Confusional state 32.17 13.91 31 28913 159861 46497257
Uterine atony 31.40 13.91 9 28935 156 46656962
Nail bed inflammation 31.07 13.91 11 28933 385 46656733
Arteriospasm coronary 30.46 13.91 22 28922 3599 46653519
Chills 30.37 13.91 129 28815 95903 46561215
Foetal exposure during pregnancy 30.22 13.91 62 28882 30685 46626433
Juvenile idiopathic arthritis 30.05 13.91 23 28921 4109 46653009
Injection site pain 27.70 13.91 16 28928 107136 46549982
Constipation 26.37 13.91 42 28902 174055 46483063
Toxic shock syndrome 25.90 13.91 10 28934 448 46656670
Microcephaly 25.18 13.91 11 28933 677 46656441
Respiratory disorder neonatal 25.03 13.91 12 28932 916 46656202
Uterine hyperstimulation 24.95 13.91 6 28938 50 46657068
Oral fibroma 24.64 13.91 6 28938 53 46657065
Disease progression 24.51 13.91 13 28931 91287 46565831
Dysmorphism 24.30 13.91 15 28929 1892 46655226
Hospitalisation 24.01 13.91 5 28939 63380 46593738
Endometritis bacterial 23.31 13.91 4 28940 3 46657115
Uterine tachysystole 23.16 13.91 5 28939 24 46657094
Hypokalaemia 22.95 13.91 13 28931 88011 46569107
Dyspnoea 22.92 13.91 207 28737 515341 46141777
Embedded device 22.91 13.91 17 28927 2899 46654219
Uterine hypertonus 22.64 13.91 7 28937 159 46656959
Pruritus 22.55 13.91 76 28868 242276 46414842
Hyponatraemia 22.36 13.91 18 28926 101314 46555804
Fatigue 22.29 13.91 256 28688 608441 46048677
Arnold-Chiari malformation 22.26 13.91 9 28935 456 46656662
Meconium in amniotic fluid 21.90 13.91 7 28937 178 46656940
Suicide attempt 21.56 13.91 4 28940 55032 46602086
Intentional overdose 21.04 13.91 7 28937 64937 46592181
Suicidal ideation 20.25 13.91 5 28939 56377 46600741
Congenital joint malformation 20.01 13.91 4 28940 12 46657106
Post procedural discomfort 19.47 13.91 10 28934 885 46656233
Coma 19.41 13.91 6 28938 58343 46598775
General physical health deterioration 19.41 13.91 26 28918 115743 46541375
Paranasal sinus hypersecretion 19.28 13.91 16 28928 3208 46653910
Uterine dilation and curettage 19.24 13.91 10 28934 907 46656211
Device difficult to use 18.80 13.91 24 28920 7980 46649138
Victim of homicide 18.71 13.91 5 28939 66 46657052
Somnolence 18.29 13.91 44 28900 156477 46500641
Maternal exposure during pregnancy 17.99 13.91 117 28827 102432 46554686
Fall 17.90 13.91 125 28819 328972 46328146
Abortion infected 17.78 13.91 4 28940 24 46657094
Rash 17.67 13.91 139 28805 356373 46300745
Pneumonia 17.62 13.91 149 28795 376171 46280947
Electrocardiogram QT prolonged 17.58 13.91 5 28939 51320 46605798
Metastases to lymph nodes 17.36 13.91 21 28923 6610 46650508
Vaginal discharge 17.35 13.91 18 28926 4790 46652328
Decreased appetite 17.20 13.91 62 28882 193774 46463344
Uterine cervix stenosis 17.17 13.91 6 28938 202 46656916
Maternal exposure timing unspecified 17.13 13.91 11 28933 1486 46655632
Foetal heart rate disorder 16.68 13.91 5 28939 102 46657016
Multiple sclerosis relapse 16.63 13.91 3 28941 42122 46614996
Spina bifida 16.15 13.91 8 28936 656 46656462
Dry skin 16.03 13.91 3 28941 41013 46616105
Uterine spasm 15.62 13.91 7 28937 458 46656660
Foetal exposure during delivery 15.55 13.91 4 28940 45 46657073
Ankylosing spondylitis 15.51 13.91 20 28924 6717 46650401
Injection site erythema 15.46 13.91 14 28930 74413 46582705
Pancreatitis 15.41 13.91 4 28940 43623 46613495
Retained placenta or membranes 15.35 13.91 6 28938 278 46656840
Dyspnoea exertional 15.30 13.91 6 28938 50283 46606835
International normalised ratio increased 15.28 13.91 5 28939 46878 46610240
Erythema 15.26 13.91 42 28902 142778 46514340
Systemic lupus erythematosus 15.11 13.91 11 28933 65169 46591949
Congenital choroid plexus cyst 15.07 13.91 6 28938 292 46656826
Synostosis 14.95 13.91 4 28940 53 46657065
Congenital pneumonia 14.77 13.91 3 28941 10 46657108
Hypercholesterolaemia 14.73 13.91 26 28918 11504 46645614
Wrist deformity 14.54 13.91 10 28934 1514 46655604
Tongue oedema 14.46 13.91 15 28929 3991 46653127
Bone contusion 14.29 13.91 8 28936 842 46656276
Polyhydramnios 14.26 13.91 11 28933 1988 46655130
Wrong technique in product usage process 14.24 13.91 8 28936 54414 46602704
Blood lactate dehydrogenase increased 14.20 13.91 36 28908 20464 46636654
Hypersensitivity 14.17 13.91 149 28795 150172 46506946
Foetal methotrexate syndrome 14.14 13.91 4 28940 66 46657052
Depression 14.06 13.91 56 28888 170048 46487070
Renal failure 14.01 13.91 31 28913 113563 46543555
Infusion related reaction 13.98 13.91 109 28835 101099 46556019

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
Foetal exposure during pregnancy 155.50 14.96 102 7188 36769 29908419
Rheumatoid arthritis 80.23 14.96 72 7218 41125 29904063
Arthralgia 70.93 14.96 122 7168 135669 29809519
Maternal exposure during pregnancy 67.96 14.96 28 7262 3843 29941345
Anencephaly 65.89 14.96 13 7277 111 29945077
Moebius II syndrome 43.93 14.96 6 7284 0 29945188
Congenital hydrocephalus 43.47 14.96 9 7281 100 29945088
Musculoskeletal pain 41.29 14.96 44 7246 30896 29914292
Pain 40.16 14.96 112 7178 172529 29772659
Micrognathia 39.79 14.96 10 7280 275 29944913
Renal aplasia 39.61 14.96 12 7278 666 29944522
Meningocele 38.72 14.96 7 7283 35 29945153
Congenital cystic kidney disease 37.78 14.96 10 7280 339 29944849
Nasopharyngitis 37.57 14.96 58 7232 58791 29886397
Stillbirth 33.28 14.96 8 7282 182 29945006
Respiratory disorder neonatal 33.01 14.96 12 7278 1176 29944012
Skull malformation 32.61 14.96 9 7281 358 29944830
Congenital cystic lung 31.52 14.96 8 7282 229 29944959
Anomaly of external ear congenital 30.36 14.96 7 7283 132 29945056
External auditory canal atresia 30.07 14.96 7 7283 138 29945050
Intervertebral disc compression 29.68 14.96 8 7282 291 29944897
Cleft lip and palate 29.49 14.96 8 7282 298 29944890
Limb malformation 28.87 14.96 8 7282 323 29944865
Heart disease congenital 28.71 14.96 11 7279 1247 29943941
Foetal growth restriction 28.55 14.96 15 7275 3570 29941618
Death 27.47 14.96 28 7262 357255 29587933
Genitalia external ambiguous 26.51 14.96 7 7283 235 29944953
Premature baby 26.36 14.96 26 7264 16665 29928523
Gastric ulcer haemorrhage 25.55 14.96 16 7274 5298 29939890
Haemangioma congenital 25.21 14.96 8 7282 518 29944670
Retroperitoneal fibrosis 25.02 14.96 7 7283 293 29944895
Liver function test abnormal 24.82 14.96 34 7256 30916 29914272
Paternal exposure before pregnancy 24.82 14.96 5 7285 48 29945140
Congenital pulmonary valve atresia 22.58 14.96 5 7285 78 29945110
Congenital tricuspid valve atresia 22.23 14.96 5 7285 84 29945104
Therapeutic product effect decreased 21.91 14.96 31 7259 29045 29916143
Swelling 20.93 14.96 34 7256 35941 29909247
Maternal drugs affecting foetus 20.88 14.96 13 7277 4260 29940928
Double outlet right ventricle 20.12 14.96 5 7285 131 29945057
Kidney duplex 19.52 14.96 6 7284 350 29944838
Talipes 19.26 14.96 9 7281 1666 29943522
Infusion related reaction 19.21 14.96 35 7255 40529 29904659
Insomnia 19.17 14.96 58 7232 93278 29851910
Terminal insomnia 18.61 14.96 6 7284 409 29944779
Arthropathy 18.50 14.96 24 7266 20703 29924485
Joint space narrowing 18.47 14.96 4 7286 56 29945132
Arachnoid cyst 17.69 14.96 5 7285 217 29944971
Decreased activity 17.66 14.96 11 7279 3610 29941578
Craniofacial deformity 17.08 14.96 4 7286 81 29945107
Contraindicated product administered 17.04 14.96 21 7269 17210 29927978
Foetal distress syndrome 16.82 14.96 7 7283 984 29944204
Alopecia 16.71 14.96 22 7268 19253 29925935
Aphthous ulcer 16.31 14.96 11 7279 4130 29941058
Cerebellar hypoplasia 15.73 14.96 3 7287 21 29945167
Rash erythematous 15.54 14.96 23 7267 22429 29922759
Neck pain 15.29 14.96 22 7268 20922 29924266
Clinodactyly 14.99 14.96 4 7286 140 29945048

Pharmacologic Action:

SourceCodeDescription
ATC A02BB01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Prostaglandins
ATC G02AD06 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
UTEROTONICS
Prostaglandins
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
FDA CS M0017811 Prostaglandins E, Synthetic
MeSH PA D000019 Abortifacient Agents
MeSH PA D000020 Abortifacient Agents, Nonsteroidal
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D010120 Oxytocics
MeSH PA D012102 Reproductive Control Agents
FDA EPC N0000175785 Prostaglandin E1 Analog
CHEBI has role CHEBI:36063 oxytocic
CHEBI has role CHEBI:49201 anti-ulcer agents
CHEBI has role CHEBI:50691 abortifacient agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postpartum hemorrhage indication 47821001
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Prevention of NSAID-Induced Gastric Ulcer indication
Prevention of CMV Disease After Organ Transplant indication
Osteoarthritis in Patients at High Ulcer Risk indication
Ankylosing spondylitis off-label use 9631008 DOID:7147
Peptic ulcer off-label use 13200003 DOID:750
Duodenal ulcer disease off-label use 51868009 DOID:1724
Cervical ripening procedure off-label use 236959001
Pregnancy with abortive outcome off-label use 363681007
Gastric ulcer off-label use 397825006 DOID:10808
NSAID-Induced Gastric Ulcer off-label use
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Gastrointestinal hemorrhage contraindication 74474003
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Non-infective meningitis contraindication 230155003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Gynecological Surgery contraindication

Acid dissociation constants calculated using MoKa v3.0.0

None

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 E2 receptor EP3 subtype GPCR AGONIST Ki 8.10 IUPHAR CHEMBL
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST Ki 7.60 IUPHAR
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 7.50 IUPHAR
Prostaglandin F2-alpha receptor GPCR Ki 5.03 PDSP

External reference:

IDSource
4019313 VUID
N0000147506 NUI
D00419 KEGG_DRUG
66792-31-2 SECONDARY_CAS_RN
4019313 VANDF
C0591321 UMLSCUI
C0377863 UMLSCUI
CHEBI:63610 CHEBI
CHEMBL606 ChEMBL_ID
D016595 MESH_DESCRIPTOR_UI
DB00929 DRUGBANK_ID
5282381 PUBCHEM_CID
C047042 MESH_SUPPLEMENTAL_RECORD_UI
5154 INN_ID
0E43V0BB57 UNII
12Z0SU967A UNII
6436406 PUBCHEM_CID
151578 RXNORM
44310 MMSL
445 MMSL
5121 MMSL
d00303 MMSL
001133 NDDF
387242007 SNOMEDCT_US
43684009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1451 TABLET 100 ug ORAL NDA 28 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1461 TABLET 200 ug ORAL NDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 10544-949 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 24 sections
Diclofenac Sodium and MisoprostolDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 10544-955 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 12634-502 TABLET 200 ug ORAL NDA authorized generic 27 sections
CYTOTEC HUMAN PRESCRIPTION DRUG LABEL 1 12634-933 TABLET 200 ug ORAL NDA 13 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 16590-024 TABLET, FILM COATED 200 ug ORAL NDA 31 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 21695-425 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-076 TABLET 200 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-754 TABLET 100 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-161 TABLET 200 ug ORAL ANDA 22 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-232 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-233 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-110 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-111 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43063-707 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-161 TABLET 200 ug ORAL ANDA 22 sections
misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43393-020 TABLET 200 ug ORAL NDA authorized generic 25 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43393-022 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43393-203 TABLET 200 ug ORAL ANDA 15 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 50090-4618 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 30 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 50436-3172 TABLET 200 ug ORAL ANDA 26 sections
misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 52959-692 TABLET 100 ug ORAL NDA 27 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 54348-148 TABLET 200 ug ORAL ANDA 22 sections