NDC Code(s) : 65649-651-02, 65649-651-03
Packager : Salix Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ucerisbudesonide 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(UNII: Q3OKS62Q6X)
(BUDESONIDE - UNII:Q3OKS62Q6X) 		BUDESONIDE28 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
STEARETH-10(UNII: FD0913P475)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
BUTANE(UNII: 6LV4FOR43R)
PROPANE(UNII: T75W9911L6)
ISOBUTANE(UNII: BXR49TP611)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65649-651-032 in 1 CARTON 12/01/2014
1NDC:65649-651-021 in 1 CANISTER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
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 Business Operations
DPT Laboratories Ltd. 832224591 MANUFACTURE(65649-651)

Establishment
Name Address ID/FEI Business Operations
Carton Services, Incorporated 928861723 PACK(65649-651)

Establishment
Name Address ID/FEI Business Operations
ASM Aerosol Service AG 480286111 MANUFACTURE(65649-651)

PRINCIPAL DISPLAY PANEL

NDC 65649-651-03

Rx only

UCERIS®
(budesonide) rectal foam
2mg/ actuation

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

 Carton