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

Stem definition	Drug id	CAS RN
prostaglandins	1817	59122-46-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.80	mg	O
0.20	mg	O
0.20	mg	V

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 27, 1988	FDA	GD SEARLE LLC

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
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 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
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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin E2 receptor EP3 subtype	GPCR	P43115	PE2R3_HUMAN	AGONIST	Ki	8.10	IUPHAR	CHEMBL
Prostaglandin E2 receptor EP4 subtype	GPCR	P35408	PE2R4_HUMAN	AGONIST	Ki	7.60	IUPHAR
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	Ki	7.50	IUPHAR
Prostaglandin F2-alpha receptor	GPCR	P43088	PF2R_HUMAN		Ki	5.03	PDSP

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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