Budesonide Inhalation Suspension

Budesonide Inhalation by

Drug Labeling and Warnings

Budesonide Inhalation by is a Prescription medication manufactured, distributed, or labeled by The Ritedose Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BUDESONIDE INHALATION- budesonide inhalation suspension suspension 
The Ritedose Corporation

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Budesonide Inhalation Suspension

NDC: 68180-984-30

Budesonide Inhalation Suspension

0.5 mg/2 mL

FOR INHALATION ONLY

Once an ampule is opened, use the contents immediately.

For use only in a jet nebulizer.

Do NOT use in an ultrasonic nebulizer.

STORE UPRIGHT

Rx only

Lupin

30 single-dose ampules per carton

Principal Display Panel - Lupin Budesonide 0.5 mg/2 mL 30 ct Carton

BUDESONIDE INHALATION 
budesonide inhalation suspension suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65302-042
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)	BUDESONIDE	0.5 mg  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65302-042-01	6 in 1 CARTON	05/21/2019
1		5 in 1 POUCH
1		2 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210897	05/21/2019

Labeler - The Ritedose Corporation (837769546)

Establishment
Name	Address	ID/FEI	Business Operations
The Ritedose Corporation		837769546	analysis(65302-042) , manufacture(65302-042) , pack(65302-042) , label(65302-042)

Revised: 12/2019

Document Id: 9a27fc4e-5c1e-9e9b-e053-2995a90aaa20

34391-3

Set id: 9a27fc4e-5c1d-9e9b-e053-2995a90aaa20

Version: 1

Effective Time: 20191220