MIFEPRISTONE

Product NDC
83114-001
11-digit product format
831140001
Labeler code
83114
Product ID
83114-001_ed8c0b7a-2dac-2bb1-e053-2a95a90aa156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mifepristone
Dosage form
TABLET
Route
ORAL
Labeler
PCI Pharma Services Canada, Inc.
Application
ANDA091178
Marketing category
ANDA
Marketing start
2019-04-11
Marketing end
0000-00-00
Substance
MIFEPRISTONE
Active strength
200 mg/1
Pharmacologic classes
Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83114-001-01831140001011 TABLET in 1 BLISTER PACK (83114-001-01) 1 tablet2019-04-110000-00-00NoNoCurrent
83114-001-06831140001066 TABLET in 1 CARTON (83114-001-06) 6 tablet2019-04-110000-00-00NoNoCurrent