PULMICORT RESPULES
PULMICORT RESPULES (BUDESONIDE INHALATION SUSPENSION)INITIAL U.S. APPROVAL 2000
Approved
Approval ID
2e0fa140-85a0-42db-ba15-a068120076b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 4, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5774
Application NumberNDA020929
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 4, 2012
FDA Product Classification
INGREDIENTS (7)
BUDESONIDEActive
Quantity: 0.25 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5621
Application NumberNDA020929
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 4, 2012
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUDESONIDEActive
Quantity: 0.5 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT