Ella
These highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella. ELLA (ulipristal acetate) tablet, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
f4c302dd-4e71-b51e-e053-2995a90aaf2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
RedPharm Drug, Inc
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ulipristal acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1466
Application NumberNDA022474
Product Classification
M
Marketing Category
C73594
G
Generic Name
ulipristal acetate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ULIPRISTAL ACETATEActive
Quantity: 30 mg in 1 1
Code: YF7V70N02B
Classification: ACTIB