ELLA Tablet Ref.[10802] Active ingredients: Ulipristal

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.

Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6. The structural formula is:

C30H37NO4

Dosage Forms and Strengths

The ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked “ella” on both sides.

How Supplied

Ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC or PVC-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with “ella” on both sides.

NDC 73302-456-01 (1 tablet unit of use package)

Manufactured for: HRA Pharma America Inc., Morristown, NJ 07960

Manufactured by: Cenexi, 95520 Osny, France, or
Laboratorios León Farma S.A., 24008 León, Spain, or
Delpharm Lille SAS, 59452 Lys-Lez-Lannoy, France

Drugs

Drug Countries
ELLA Canada, Hong Kong, Israel, Singapore, Turkey, United States

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