BUDESONIDE INHALATION- budesonide inhalation suspension suspension 
The Ritedose Corporation

----------

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 30 ct Carton

BUDESONIDE INHALATION 
budesonide inhalation suspension suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65302-042
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) BUDESONIDE0.5 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65302-042-016 in 1 CARTON05/21/2019
15 in 1 POUCH
12 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21089705/21/2019
Labeler - The Ritedose Corporation (837769546)
Establishment
NameAddressID/FEIBusiness Operations
The Ritedose Corporation837769546analysis(65302-042) , manufacture(65302-042) , pack(65302-042) , label(65302-042)

Revised: 12/2019
Document Id: 9a27fc4e-5c1e-9e9b-e053-2995a90aaa20
Set id: 9a27fc4e-5c1d-9e9b-e053-2995a90aaa20
Version: 1
Effective Time: 20191220
 
The Ritedose Corporation