Budesonide
These highlights do not include all the information needed to use BUDESONIDE INHALATION SUSPENSION safely and effectively. See full prescribing information for BUDESONIDE INHALATION SUSPENSION.BUDESONIDE INHALATION SUSPENSION.Initial U.S. Approval: 2000
Approved
Approval ID
d9656442-4587-4867-9a8c-5f5b0402936e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2020
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
Products 3
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 Code76282-640
Application NumberANDA205710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2020
FDA Product Classification
INGREDIENTS (6)
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
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-641
Application NumberANDA205710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2020
FDA Product Classification
INGREDIENTS (6)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUDESONIDEActive
Quantity: 0.5 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-642
Application NumberANDA205710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2020
FDA Product Classification
INGREDIENTS (6)
BUDESONIDEActive
Quantity: 1 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT