Uceris (Page 5 of 5)

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

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(click image for full-size original)
UCERIS budesonide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MX9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68012-309-02 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
2 NDC:68012-309-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68012-309-01 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
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: 04/2020 Santarus Inc.

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