FDA.reportPublic FDA data

misoprostol

Product NDC
59762-5007
11-digit product format
597625007
Labeler code
59762
Product ID
59762-5007_d589d579-353b-49c6-af7f-da02e8a6084e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA019268
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-12-27
Substance
MISOPROSTOL
Active strength
100 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
misoprostol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57
Rxcui311727, 317128

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-5007-1misoprostol60 in 1 BOTTLETABLET6015
59762-5007-2misoprostol120 in 1 BOTTLETABLET12015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5007-1EA - Each59762-50072fc7a1b3-980b-43d2-b991-4858f271b2fa12012-07-24
59762-5007-2EA - Each59762-50074fe02fd7-6d64-41dc-a108-b76dbacfd46c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [GREENSTONE LLC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [GREENSTONE LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [GREENSTONE LLC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [GREENSTONE LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [GREENSTONE LLC]7
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
59762-5007MISOPROSTOL TABLET [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20250525_c4fe14fb-0a43-4c31-9cd6-29eb0d156705.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSNc842c35f-6a64-4ecc-95a1-41b6d056047e101
311727misoprostol 0.1 MG Oral TabletSCDc842c35f-6a64-4ecc-95a1-41b6d056047e101
311727misoprostol 100 MCG Oral TabletSYc842c35f-6a64-4ecc-95a1-41b6d056047e101
311727miSOPROStol 100 MCG Oral TabletPSNc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
317128miSOPROStol 200 MCG Oral TabletPSNc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
311727misoprostol 0.1 MG Oral TabletSCDc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
317128misoprostol 0.2 MG Oral TabletSCDc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
311727misoprostol 100 MCG Oral TabletSYc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
317128misoprostol 200 MCG Oral TabletSYc4fe14fb-0a43-4c31-9cd6-29eb0d15670515
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-5007-15976250070160 TABLET in 1 BOTTLE (59762-5007-1) 60 tablet2009-12-270000-00-00NoNoCurrent
59762-5007-259762500702120 TABLET in 1 BOTTLE (59762-5007-2) 120 tablet2009-12-270000-00-00NoNoCurrent