NDC Code(s) : 68682-658-02, 68682-658-03
Packager : Oceanside Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

budesonidebudesonide AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-658
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:68682-658-032 in 1 CARTON 15/07/2022
1NDC:68682-658-021 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 07/15/2022

LABELER - Oceanside Pharmaceuticals(832011691)

Establishment
Name Address ID/FEI Business Operations
DPT Laboratories, Ltd. 832224690 MANUFACTURE(68682-658)

Establishment
Name Address ID/FEI Business Operations
ASM Aerosol Service AG 480286111 MANUFACTURE(68682-658)

PRINCIPAL DISPLAY PANEL

NDC 68682-658-03

Rx only

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.

OCEANSIDE
PHARMACEUTICALS

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