Uceris Tablets

Name: Uceris Tablets

Principal display panel

 PACKAGE LABEL – PRINCIPAL DISPLAY PANEL 9 mg

NDC 68012-309-30

Rx only

UCERIS®

(budesonide) extended release tablets

9 mg

Swallow tablet whole, do not chew or break.

30 Tablets

Salix
PHARMACEUTICALS

UCERIS 
budesonide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68012-309
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 9 mg
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID  
LECITHIN, SOYBEAN  
LACTOSE, UNSPECIFIED FORM  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
TALC  
TRIETHYL CITRATE  
TITANIUM DIOXIDE  
MICROCRYSTALLINE CELLULOSE  
HYDROXYPROPYL CELLULOSE (80000 MW)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MX9
Contains     
Packaging
# Item Code Package Description
1 NDC:68012-309-02 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 NDC:68012-309-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
3 NDC:68012-309-01 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203634 01/14/2013
Labeler - Santarus Inc. (104286369)
Establishment
Name Address ID/FEI Operations
Cosmo SpA 630431955 MANUFACTURE(68012-309)
Establishment
Name Address ID/FEI Operations
Carton Service Incorporated 928861723 PACK(68012-309), LABEL(68012-309)
Establishment
Name Address ID/FEI Operations
Patheon Puerto Rico, Inc. 143814544 LABEL(68012-309), PACK(68012-309)
Revised: 11/2016   Santarus Inc.
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