Ella (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 30 mg Tablet Blister Pack Carton

NDC 73302-456 -01
ella®
ulipristal acetate
tablet 30 mg
HRA Pharma
Rx only
Contains 1 Tablet
ella®
ulipristal acetate
tablet 30 mg
Each tablet contains
30 mg ulipristal acetate.
Usual dose: See package insert.
Take one tablet as soon as possible, within 5 days after unprotected intercourse.
Ella is contraindicated during pregnancy.
Store at 20-25°C (68-77°F). [See USP controlled room temperature.]
Keep the blister in the outer carton in order to protect from light.
Keep out of reach of children.
For Medical Emergencies — Contact HRA Pharma America Inc, Health and Safety Team at 844-994-0329
HRA Pharma
Manufactured for
HRA Pharma America Inc.
36 Cattano Ave. Suite 400 Morristown,
NJ 07960
Under License From:
Laboratoire HRA Pharma
92330 Chatillon, France
Product of Spain
Manufactured By:
Delpharm Lille S.A.S.
PARC D’ACTIVITE ROUBAIX EST
22 RUE DE TOUFFLERS
CS 50070
59492 LYS LEZ LANNOY
FRANCE5044762

carton
(click image for full-size original)

ella®
ulipristal acetate table 30 mg

N 73302-456-1
Push through from front
Contains 1
30 mg tablet
Manufactured for:
HRA Pharma America Inc.,
36 Cattano Ave. Suite 400
Morristown, NJ 07960
LOT:
EXP:5044761

Blister Label
(click image for full-size original)
ELLA ulipristal acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73302-456
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:73302-456-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (73302-456-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022474 05/11/2020
Labeler — HRA Pharma America, Inc. (081160441)
Registrant — Laboratoire HRA Pharma (502511996)
Establishment
Name Address ID/FEI Operations
Delpharm Lille S.A.S. 283582547 manufacture (73302-456), analysis (73302-456), pack (73302-456)
Establishment
Name Address ID/FEI Operations
CENEXI 263382610 manufacture (73302-456), analysis (73302-456), pack (73302-456)
Establishment
Name Address ID/FEI Operations
Laboratorios Leon Farma S.A. 467782459 manufacture (73302-456), analysis (73302-456), pack (73302-456)

Revised: 06/2021 HRA Pharma America, Inc.

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