Budesonide Inhalation (Page 9 of 9)

PRINCIPAL DISPLAY PANEL 0.25 mg/2 mL

Budesonide Inhalation Suspension 0.25mg per 2mL
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BUDESONIDE INHALATION budesonide suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8429(NDC:0115-1687)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 0.25 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM
EDETATE DISODIUM
POLYSORBATE 80
CITRIC ACID MONOHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8429-3 6 POUCH in 1 CARTON contains a POUCH
1 5 VIAL in 1 POUCH This package is contained within the CARTON (68788-8429-3) and contains a VIAL
1 2 mL in 1 VIAL This package is contained within a POUCH and a CARTON (68788-8429-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078404 04/24/2023
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-8429)

Revised: 03/2024 Preferred Pharmaceuticals Inc.

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