Misoprostol

Product NDC
43393-022
11-digit product format
433930022
Labeler code
43393
Product ID
43393-022_d64b83bd-1341-0769-e053-2a95a90a9ed7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
GenBioPro, Inc.
Application
ANDA091667
Marketing category
ANDA
Marketing start
2020-04-27
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43393-022MISOPROSTOL (MISOPROSTOL) TABLET [GENBIOPRO, INC.]5Legacy NDC20240110_99ce26c1-4e24-4b26-b76d-0b25c8d71313.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43393-022-04433930022044 TABLET in 1 BOTTLE (43393-022-04) 4 tablet2020-04-270000-00-00NoNoCurrent