Misoprostol

Product NDC
69189-0161
11-digit product format
691890161
Labeler code
69189
Product ID
69189-0161_8d27861b-f767-4d46-9472-623919e456b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Avera McKennan Hospital
Application
ANDA091667
Marketing category
ANDA
Marketing start
2015-04-06
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-0161-12020-01-31C16284748780-19d75b9d0-7fcf-f424-e053-dadaa90a57ceMisoprostol Tablets GAVIS Pharmaceuticals, LLC
69189-0161-42020-01-31C16284748780-19d75b9d0-7fcf-f424-e053-dadaa90a57ceMisoprostol Tablets GAVIS Pharmaceuticals, LLC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-0161-1Misoprostol1 in 1 DOSE PACKTABLET11
69189-0161-4Misoprostol4 in 1 DOSE PACKTABLET41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-0161MISOPROSTOL TABLET [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 2 package rows20151218_aabee26a-3a04-41a1-a0cf-764710a4f6cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317128miSOPROStol 200 MCG Oral TabletPSNaabee26a-3a04-41a1-a0cf-764710a4f6cc1
317128misoprostol 0.2 MG Oral TabletSCDaabee26a-3a04-41a1-a0cf-764710a4f6cc1
317128misoprostol 200 MCG Oral TabletSYaabee26a-3a04-41a1-a0cf-764710a4f6cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-0161-1691890161011 in 1 DOSE PACKHistorical
69189-0161-4691890161044 in 1 DOSE PACKHistorical