Mifepristone
These highlights do not include all the information needed to use MIFEPRISTONE TABLETS safely and effectively. See full prescribing information for MIFEPRISTONE TABLETS. MIFEPRISTONE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
5e09acc0-fd26-4722-b8b3-46e560390d47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mifepristone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-4390
Application NumberANDA211436
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mifepristone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2022
FDA Product Classification
INGREDIENTS (13)
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7
Classification: IACT
MIFEPRISTONEActive
Quantity: 300 mg in 1 1
Code: 320T6RNW1F
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT