misoprostol

Product NDC
71335-9631
11-digit product format
713359631
Labeler code
71335
Product ID
71335-9631_4629ba57-842d-45ec-8bf9-a1ed10a0a429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019268
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-12-27
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0E43V0BB57MISOPROSTOL59122-46-2MISOPROSTOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9631-17133596310128 TABLET in 1 BOTTLE (71335-9631-1) 28 tablet2023-01-31NoNoHistorical
71335-9631-27133596310290 TABLET in 1 BOTTLE (71335-9631-2) 90 tablet2023-01-31NoNoHistorical
71335-9631-37133596310330 TABLET in 1 BOTTLE (71335-9631-3) 30 tablet2023-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Misoprostol TabletsBryant Ranch Prepack2023-11-10HUMAN PRESCRIPTION DRUG LABEL101