FDA.reportPublic FDA data

misoprostol

Product NDC
52959-692
11-digit product format
529590692
Labeler code
52959
Product ID
52959-692_9355aee3-c2a5-485f-ae95-cf93bfc0a57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA019268
Marketing category
NDA
Marketing start
2009-12-27
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
100 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-692-122019-11-13C16284748780-197449f38-bd71-f6ea-e053-dbdaa90aa703Misoprostol Tablets
52959-692-282019-11-13C16284748780-197449f38-bd71-f6ea-e053-dbdaa90aa703Misoprostol Tablets
52959-692-302019-11-13C16284748780-197449f38-bd71-f6ea-e053-dbdaa90aa703Misoprostol Tablets
52959-692-402019-11-13C16284748780-197449f38-bd71-f6ea-e053-dbdaa90aa703Misoprostol Tablets
52959-692-602019-11-13C16284748780-197449f38-bd71-f6ea-e053-dbdaa90aa703Misoprostol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-692-12misoprostol12 in 1 BOTTLETABLET122
52959-692-28misoprostol28 in 1 BOTTLETABLET282
52959-692-30misoprostol30 in 1 BOTTLETABLET302
52959-692-40misoprostol40 in 1 BOTTLETABLET402
52959-692-60misoprostol60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-692-12EA - Each52959-692d91a9ca1-d507-4e87-b413-aebed276dfc412012-07-24
52959-692-28EA - Each52959-6925c5731cb-de73-4b3c-a388-0375cc32635412012-07-24
52959-692-30EA - Each52959-692c1cf1682-c8e9-440f-b677-420bf15d5be312012-07-24
52959-692-40EA - Each52959-6922c877558-8bd7-4392-9ffd-0d98c0e78e9b12012-07-24
52959-692-60EA - Each52959-69246821f8d-3630-49ee-9c49-d8562c6afb9012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
misoprostolACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
misoprostolACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-692MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 5 package rows20120120_a5e5413d-bc22-4ae1-959b-0eb0430dbd38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSNa5e5413d-bc22-4ae1-959b-0eb0430dbd382
311727misoprostol 0.1 MG Oral TabletSCDa5e5413d-bc22-4ae1-959b-0eb0430dbd382
311727misoprostol 100 MCG Oral TabletSYa5e5413d-bc22-4ae1-959b-0eb0430dbd382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-692-125295906921212 in 1 BOTTLEHistorical
52959-692-285295906922828 in 1 BOTTLEHistorical
52959-692-305295906923030 in 1 BOTTLEHistorical
52959-692-405295906924040 in 1 BOTTLEHistorical
52959-692-605295906926060 in 1 BOTTLEHistorical