misoprostol

Product NDC
67296-1936
11-digit product format
672961936
Labeler code
67296
Product ID
67296-1936_46e93923-334c-68db-e063-6394a90ad902
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
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
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
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57
Rxcui317128

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
67296-1936-1misoprostol10 in 1 BOTTLETABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1936MISOPROSTOL TABLET [REDPHARM DRUG]1Current NDC, 1 package rows20250309_2fd197c6-05db-5011-e063-6294a90a585d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1936-16729619360110 TABLET in 1 BOTTLE (67296-1936-1) 10 tablet2009-12-27NoNoHistorical