Uceris (Page 7 of 7)

PACKAGE LABEL – PRINCIPAL DISPLAY — UCERIS® rectal foam 2 MG Carton

NDC 65649-651-03

UCERIS®
(budesonide) rectal foam
2mg/actuation

Rx ONLY

For rectal administration only, as directed by a physician. Shake well before using.

Each canister contains 14 metered doses.
Net weight 33.4 g per canister.

SALIX Pharmaceuticals

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(click image for full-size original)

UCERIS budesonide aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65649-651
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 28 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
CETYL ALCOHOL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
WATER
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65649-651-03 2 CANISTER in 1 CARTON contains a CANISTER (65649-651-02)
1 NDC:65649-651-02 1 AEROSOL, FOAM in 1 CANISTER This package is contained within the CARTON (65649-651-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205613 12/01/2014
Labeler — Salix Pharmaceuticals, Inc. (793108036)
Establishment
Name Address ID/FEI Operations
DPT Laboratories Ltd. 832224591 MANUFACTURE (65649-651)
Establishment
Name Address ID/FEI Operations
Carton Service, Incorporated 928861723 PACK (65649-651)

Revised: 04/2020 Salix Pharmaceuticals, Inc.

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