Misoprostol

Product NDC
63629-7929
11-digit product format
636297929
Labeler code
63629
Product ID
63629-7929_cd40b6e7-3ba6-4311-9cd1-6b512b820280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091667
Marketing category
ANDA
Marketing start
2012-07-25
Marketing end
0000-00-00
Substance
MISOPROSTOL
Active strength
100 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-7929-1Misoprostol28 in 1 BOTTLETABLET283
63629-7929-2Misoprostol90 in 1 BOTTLETABLET903
63629-7929-3Misoprostol30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7929MISOPROSTOL TABLET [BRYANT RANCH PREPACK]3Legacy NDC, 3 package rows20220118_7b873139-24ea-41b9-aa93-9f3297d8c7da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311727miSOPROStol 100 MCG Oral TabletPSN7b873139-24ea-41b9-aa93-9f3297d8c7da3
311727misoprostol 0.1 MG Oral TabletSCD7b873139-24ea-41b9-aa93-9f3297d8c7da3
311727misoprostol 100 MCG Oral TabletSY7b873139-24ea-41b9-aa93-9f3297d8c7da3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7929-16362979290128 TABLET in 1 BOTTLE (63629-7929-1) 28 tablet2020-10-150000-00-00NoNoCurrent
63629-7929-26362979290290 TABLET in 1 BOTTLE (63629-7929-2) 90 tablet2019-02-280000-00-00NoNoCurrent
63629-7929-36362979290330 TABLET in 1 BOTTLE (63629-7929-3) 30 tablet2020-09-230000-00-00NoNoCurrent