FDA.reportPublic FDA data

misoprostol

Product NDC
59762-5008
11-digit product format
597625008
Labeler code
59762
Product ID
59762-5008_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
200 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
MISOPROSTOL200 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
59762-5008-1misoprostol60 in 1 BOTTLETABLET6015
59762-5008-2misoprostol100 in 1 BOTTLETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5008-1EA - Each59762-5008fb631041-52ae-41da-ab1d-40826b2951db12012-07-24
59762-5008-2EA - Each59762-5008317b26a2-c298-411d-bcda-ab90fabefd0e12012-07-24

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 [DISPENSING SOLUTIONS, INC.]2
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57MISOPROSTOL TABLET [APOTHECA, INC.]2
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [DISPENSING SOLUTIONS, INC.]2
MISOPROSTOLACTIVE MOIETY0E43V0BB57MISOPROSTOL TABLET [APOTHECA, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMISOPROSTOL TABLET [APOTHECA, INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [DISPENSING SOLUTIONS, INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMISOPROSTOL TABLET [APOTHECA, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [APOTHECA, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMISOPROSTOL TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MISOPROSTOL TABLET [APOTHECA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-5008MISOPROSTOL 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 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
317128miSOPROStol 200 MCG Oral TabletPSNf15b41bd-ed36-4908-aba5-f0a019b7a26e6
317128misoprostol 0.2 MG Oral TabletSCDf15b41bd-ed36-4908-aba5-f0a019b7a26e6
317128misoprostol 200 MCG Oral TabletSYf15b41bd-ed36-4908-aba5-f0a019b7a26e6
317128miSOPROStol 200 MCG Oral TabletPSN2fd197c6-05db-5011-e063-6294a90a585d3
317128misoprostol 0.2 MG Oral TabletSCD2fd197c6-05db-5011-e063-6294a90a585d3
317128misoprostol 200 MCG Oral TabletSY2fd197c6-05db-5011-e063-6294a90a585d3
317128miSOPROStol 200 MCG Oral TabletPSN1f81237e-2cf7-4c85-a054-daffe5bb1c682
317128misoprostol 0.2 MG Oral TabletSCD1f81237e-2cf7-4c85-a054-daffe5bb1c682
317128misoprostol 200 MCG Oral TabletSY1f81237e-2cf7-4c85-a054-daffe5bb1c682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-5008-15976250080160 TABLET in 1 BOTTLE (59762-5008-1) 60 tablet2009-12-270000-00-00NoNoCurrent
59762-5008-259762500802100 TABLET in 1 BOTTLE (59762-5008-2) 100 tablet2009-12-270000-00-00NoNoCurrent