misoprostol

Product NDC
43393-020
11-digit product format
433930020
Labeler code
43393
Product ID
43393-020_d64b80a2-6a77-2309-e053-2a95a90af630
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MISOPROSTOL
Dosage form
TABLET
Route
ORAL
Labeler
GenBioPro, Inc.
Application
NDA019268
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-12-27
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43393-020-04EA - Each43393-020ab1448bc-f8f5-4370-bade-2e2afcfd33fb12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43393-020MISOPROSTOL TABLET [GENBIOPRO, INC.]6Legacy NDC20240110_c5d0b74b-e5bc-4e81-91e8-4bfc587bf54c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43393-020-04433930020044 TABLET in 1 BOTTLE (43393-020-04) 4 tablet2020-03-180000-00-00NoNoCurrent