FDA.reportPublic FDA data

MISOPROSTOL

Product NDC
42571-253
11-digit product format
425710253
Labeler code
42571
Product ID
42571-253_35016de6-7e52-0209-e063-6394a90ade8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA216872
Marketing category
ANDA
Marketing start
2023-01-01
Substance
MISOPROSTOL
Active strength
100 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MISOPROSTOL
Listing expiration
2026-12-31

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
42571-253-12MISOPROSTOL120 in 1 BOTTLETABLET1202
42571-253-60MISOPROSTOL60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-253MISOPROSTOL TABLET [MICRO LABS LIMITED]2Current NDC, Legacy NDC, 2 package rows20250515_54d26ca3-d309-4048-8699-a04b3854ef9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSN54d26ca3-d309-4048-8699-a04b3854ef9c2
317128miSOPROStol 200 MCG Oral TabletPSN54d26ca3-d309-4048-8699-a04b3854ef9c2
311727misoprostol 0.1 MG Oral TabletSCD54d26ca3-d309-4048-8699-a04b3854ef9c2
317128misoprostol 0.2 MG Oral TabletSCD54d26ca3-d309-4048-8699-a04b3854ef9c2
311727misoprostol 100 MCG Oral TabletSY54d26ca3-d309-4048-8699-a04b3854ef9c2
317128misoprostol 200 MCG Oral TabletSY54d26ca3-d309-4048-8699-a04b3854ef9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-253-1242571025312120 TABLET in 1 BOTTLE (42571-253-12) 120 tablet2023-01-010000-00-00NoNoCurrent
42571-253-604257102536060 TABLET in 1 BOTTLE (42571-253-60) 60 tablet2023-01-010000-00-00NoNoCurrent