Ella (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

ella® (ulipristal acetate) tablet 30 mg
NDC 50102-911-01Carton x 1 tablet

ella® (ulipristal acetate) tablet 30 mg NDC 50102-911-01 Carton x 1 tablet
(click image for full-size original)
ELLA ulipristal acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50102-911
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULIPRISTAL ACETATE (ULIPRISTAL) ULIPRISTAL ACETATE 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POVIDONE K30
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code ella
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50102-911-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (50102-911-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022474 08/13/2010
Labeler — Afaxys Inc. (080508656)
Registrant — Laboratoire HRA Pharma (502511996)
Establishment
Name Address ID/FEI Operations
Crystal Pharma, SAU 563371111 API MANUFACTURE (50102-911), ANALYSIS (50102-911), PACK (50102-911)
Establishment
Name Address ID/FEI Operations
Laboratorios Leon Farma S.A. 467782459 MANUFACTURE (50102-911), ANALYSIS (50102-911), PACK (50102-911)
Establishment
Name Address ID/FEI Operations
Delpharm Lille S.A.S. 283582547 MANUFACTURE (50102-911), ANALYSIS (50102-911), PACK (50102-911)

Revised: 09/2017 Afaxys Inc.

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