Misoprostol

Product NDC
70710-1007
11-digit product format
707101007
Labeler code
70710
Product ID
70710-1007_8ccd806a-64c5-451e-89c9-f3920585a42f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA210201
Marketing category
ANDA
Marketing start
2020-01-14
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1007-170710100701100 TABLET in 1 BOTTLE (70710-1007-1) 100 tablet2020-01-140000-00-00NoNoCurrent
70710-1007-47071010070410 BLISTER PACK in 1 CARTON (70710-1007-4) > 10 TABLET in 1 BLISTER PACK (70710-1007-2) 10 blister pack2020-01-140000-00-00NoNoCurrent
70710-1007-67071010070660 TABLET in 1 BOTTLE (70710-1007-6) 60 tablet2020-01-140000-00-00NoNoCurrent
70710-1007-870710100708120 TABLET in 1 BOTTLE (70710-1007-8) 120 tablet2020-01-140000-00-00NoNoCurrent