NDC 83114-001

MIFEPRISTONE

Mifepristone

MIFEPRISTONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pci Pharma Services Canada, Inc.. The primary component is Mifepristone.

Product ID83114-001_ed8c0b7a-2dac-2bb1-e053-2a95a90aa156
NDC83114-001
Product TypeHuman Prescription Drug
Proprietary NameMIFEPRISTONE
Generic NameMifepristone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-11
Marketing CategoryANDA /
Application NumberANDA091178
Labeler NamePCI Pharma Services Canada, Inc.
Substance NameMIFEPRISTONE
Active Ingredient Strength200 mg/1
Pharm ClassesProgestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 83114-001-01

1 TABLET in 1 BLISTER PACK (83114-001-01)
Marketing Start Date2019-04-11
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "MIFEPRISTONE" or generic name "Mifepristone"

NDCBrand NameGeneric Name
43393-001MifepristoneMIFEPRISTONE
83114-001MIFEPRISTONEmifepristone
76346-073KorlymMifepristone

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