Misoprostol

Product NDC
50436-3172
11-digit product format
504363172
Labeler code
50436
Product ID
50436-3172_2246d2f2-ea10-4460-a664-b5c4635cc3e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091667
Marketing category
ANDA
Marketing start
2013-04-12
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3172-1Misoprostol4 in 1 BOTTLETABLET44
50436-3172-2Misoprostol3 in 1 BOTTLETABLET34
50436-3172-3Misoprostol9 in 1 BOTTLETABLET94
50436-3172-4Misoprostol8 in 1 BOTTLETABLET84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3172MISOPROSTOL TABLET [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20180301_6801a2df-2ed3-43c8-84d3-6855800589ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSN6801a2df-2ed3-43c8-84d3-6855800589ed4
317128misoprostol 0.2 MG Oral TabletSCD6801a2df-2ed3-43c8-84d3-6855800589ed4
317128misoprostol 200 MCG Oral TabletSY6801a2df-2ed3-43c8-84d3-6855800589ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3172-1504363172014 in 1 BOTTLEHistorical
50436-3172-2504363172023 in 1 BOTTLEHistorical
50436-3172-3504363172039 in 1 BOTTLEHistorical
50436-3172-4504363172048 in 1 BOTTLEHistorical